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The purpose of this research study is to investigate the effectiveness of a new rehabilitation for visual hemianopia. The study team believes a cross-modal rehabilitation technique delivered by a virtual reality system can help restore the visual field for subjects with homonymous hemianopia.
The study tests a novel rehabilitation system, translated from promising cross-modal rehabilitation animal research, that is the first treatment capable of restoring the visual field for hemianopia patients. This noninvasive technique uses a virtual reality device to deliver visual and auditory stimulus. The goals of this study are to obtain proof of concept and procure rehabilitation data to support the development of this novel rehabilitation treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group Virtual Reality (VR) Treatment | Experimental | Visual Auditory Virtual Reality rehabilitation for visual hemianopia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-model Visual Auditory Rehabilitation | Device | Subjects will put on a virtual reality rehabilitation system which will present sights and sounds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humphrey Visual Field Perimetry | The area of the subject's visual field measured by 30-2 Humphrey visual field (HVF) perimetry. Both left and right sides will be tested. The deficit side includes is the hemianopic side. The intact side is the non-hemianopic side. During the HVF test, light is projected into a white bowl with a standardized background light intensity to form a circular stimulus, around 30 cm away from the patient's eye. The overall field mapping technique used is a form of static perimetry, where a stimulus appears in various areas of the field of vision. The patient indicates when they can see the stimulus and the perimetrist then records the point where the stimulus was seen. These data points are used to determine the patient's visual field. | Baseline |
| Humphrey Visual Field Perimetry | The area of the subject's visual field measured by 30-2 Humphrey visual field (HVF) perimetry. Both left and right sides will be tested. The deficit side includes is the hemianopic side. The intact side is the non-hemianopic side. During the HVF test, light is projected into a white bowl with a standardized background light intensity to form a circular stimulus, around 30 cm away from the patient's eye. The overall field mapping technique used is a form of static perimetry, where a stimulus appears in various areas of the field of vision. The patient indicates when they can see the stimulus and the perimetrist then records the point where the stimulus was seen. These data points are used to determine the patient's visual field. | up to 2 Months |
| Virtual Reality (VR) Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 1 |
| Virtual Reality Visual Field Test--Mean Percent Correct |
| Measure | Description | Time Frame |
|---|---|---|
| National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Grating Acuity Test | Change in the percentage of correctly identified trials. | First visit after the completion of rehabilitation (1 or 2 months) |
| Color Vision Test | Change in the percentage of correctly identified trials for each color. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huai Jiang, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27101 | United States |
All of the individual participant data that underlie the results reported in the publication will be shared after deidentification (text, tables, figures, and appendices)
Data will be made available immediately following publication for five years.
Anyone who wishes to access the data for any purpose.
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Six subjects signed consent. One screen failed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group Virtual Reality (VR) Treatment | Visual Auditory Virtual Reality rehabilitation for visual hemianopia Cross-model Visual Auditory Rehabilitation: Subjects will put on a virtual reality rehabilitation system which will present sights and sounds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population includes only subjects who met screening criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group Virtual Reality (VR) Treatment | Visual Auditory Virtual Reality rehabilitation for visual hemianopia Cross-model Visual Auditory Rehabilitation: Subjects will put on a virtual reality rehabilitation system which will present sights and sounds. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Humphrey Visual Field Perimetry | The area of the subject's visual field measured by 30-2 Humphrey visual field (HVF) perimetry. Both left and right sides will be tested. The deficit side includes is the hemianopic side. The intact side is the non-hemianopic side. During the HVF test, light is projected into a white bowl with a standardized background light intensity to form a circular stimulus, around 30 cm away from the patient's eye. The overall field mapping technique used is a form of static perimetry, where a stimulus appears in various areas of the field of vision. The patient indicates when they can see the stimulus and the perimetrist then records the point where the stimulus was seen. These data points are used to determine the patient's visual field. | Analysis only includes subjects who completed study. | Posted | Mean | Standard Deviation | visual angle degrees^2 | Baseline | eyes | eyes |
|
Baseline through 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group Virtual Reality (VR) Treatment | Visual Auditory Virtual Reality rehabilitation for visual hemianopia Cross-model Visual Auditory Rehabilitation: Subjects will put on a virtual reality rehabilitation system which will present sights and sounds. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huai Jiang, PhD | Wake Forest School of Medicine | 336-695-6460 | jianghuai.ws@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Jul 29, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2021 | Aug 27, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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All study participants will be given the same treatment.
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Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. |
| Day 2 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 3 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 4 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 5 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 6 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 7 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 8 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 9 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 10 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 11 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 12 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 13 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 14 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 15 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 16 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 17 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 18 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 19 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 20 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 21 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 22 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 23 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 24 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 25 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 26 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 27 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 28 |
| Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Day 29 |
| Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | Baseline |
| Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | up to 2 Months |
| Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | 3 Months |
| Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | 6 Months |
| Baseline, 2 months, 3 months |
| NEI-VFQ-25--Composite Score | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life. | 6 month |
| NEI-VFQ-25--General Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Health Score is a subscale that measures the participant's self-report of their overall health. The score ranges from 0 to 100. A higher score denotes better perception of overall health. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--General Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Health Score is a subscale that measures the participant's self-report of their overall health. The score ranges from 0 to 100. A higher score denotes better perception of overall health. | 6 months |
| NEI-VFQ-25--General Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Vision Score measures the participant's reported quality of vision. The score ranges from 0 to 100. A higher score denotes a better perception of vision | Baseline, 2 months, 3 months |
| NEI-VFQ-25--General Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Vision Score measures the participant's reported quality of vision. The score ranges from 0 to 100. A higher score denotes a better perception of vision | 6 months |
| NEI-VFQ-25--Ocular Pain Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Ocular Pain Score Subscale measures reported pain or discomfort in and around the eyes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to ocular pain. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Ocular Pain Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Ocular Pain Score Subscale measures reported pain or discomfort in and around the eyes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to ocular pain. | 6 months |
| NEI-VFQ-25--Near Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Near Activities Score Subscale measures difficulty with performing near activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to near activities. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Near Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Near Activities Score Subscale measures difficulty with performing near activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to near activities. | 6 months |
| NEI-VFQ-25--Distance Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Distance Activities Score Subscale measures difficulty with performing distance activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to distance activities. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Distance Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Distance Activities Score Subscale measures difficulty with performing distance activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to distance activities. | 6 months |
| NEI-VFQ-25--Social Functioning Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Social Functioning Score Subscale measures how vision difficulties affect social functioning. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to social functioning. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Social Functioning Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Social Functioning Score Subscale measures how vision difficulties affect social functioning. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to social functioning. | 6 months |
| NEI-VFQ-25--Mental Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Mental Health Score Subscale measures how much patients feel vision affects their mental health. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to mental health. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Mental Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Mental Health Score Subscale measures how much patients feel vision affects their mental health. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to mental health. | 6 months |
| NEI-VFQ-25--Role Difficulties Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Role Difficulties Score Subscale measures how limited by their vision patients feel they are. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to role difficulties. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Role Difficulties Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Role Difficulties Score Subscale measures how limited by their vision patients feel they are. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to role difficulties. | 6 months |
| NEI-VFQ-25--Dependency Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Dependency Score Subscale measures how much patients are dependent on other people due to their vision. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to dependency. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Dependency Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Dependency Score Subscale measures how much patients are dependent on other people due to their vision. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to dependency. | 6 months |
| NEI-VFQ-25--Driving Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Driving Score Subscale measures patients' reported difficulty with driving. The score ranges from 0 to 100. Patients who do not drive are not given a driving score. A higher score denotes better vision-specific quality of life related to driving. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Driving Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Driving Score Subscale measures patients' reported difficulty with driving. The score ranges from 0 to 100. Patients who do not drive are not given a driving score. A higher score denotes better vision-specific quality of life related to driving. | 6 months |
| NEI-VFQ-25--Color Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Color Vision Score Subscale measures how much difficulty patients have with using color vision to complete daily activities such as picking out clothes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to color vision. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Color Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Color Vision Score Subscale measures how much difficulty patients have with using color vision to complete daily activities such as picking out clothes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to color vision. | 6 months |
| NEI-VFQ-25--Peripheral Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Peripheral Vision Score Subscale measures how much difficulty patients have with their peripheral vision to complete daily activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to peripheral vision. | Baseline, 2 months, 3 months |
| NEI-VFQ-25--Peripheral Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Peripheral Vision Score Subscale measures how much difficulty patients have with their peripheral vision to complete daily activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to peripheral vision. | 6 months |
| Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity. | Baseline, 2 months |
| VA LV VFQ-48--Item Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity. | 3 months |
| VA LV VFQ-48--Item Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity. | 6 months |
| VA LV VFQ-48--Composite Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better. | Baseline, 2 months |
| VA LV VFQ-48--Composite Score | he VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better. | 3 months |
| VA LV VFQ-48--Composite Score | he VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better. | 6 months |
| VA LV VFQ-48--Reading Domain Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). | Baseline, 2 months |
| VA LV VFQ-48--Reading Domain Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). | 3 months |
| VA LV VFQ-48--Reading Domain Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). | 6 months |
| First visit after the completion of rehabilitation (1 or 2 months) |
| Shape Recognition Test | Change in the percentage of correctly identified trials. | First visit after the completion of rehabilitation (1 or 2 months) |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Visual Auditory Virtual Reality rehabilitation for visual hemianopia group--deficit eye. Deficit eye is the hemianopic side. |
| OG001 | Virtual Reality (VR) Treatment-Intact | Visual Auditory Virtual Reality rehabilitation for visual hemianopia group--intact eye. Intact eye is non-hemianopic side. |
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| Primary | Humphrey Visual Field Perimetry | The area of the subject's visual field measured by 30-2 Humphrey visual field (HVF) perimetry. Both left and right sides will be tested. The deficit side includes is the hemianopic side. The intact side is the non-hemianopic side. During the HVF test, light is projected into a white bowl with a standardized background light intensity to form a circular stimulus, around 30 cm away from the patient's eye. The overall field mapping technique used is a form of static perimetry, where a stimulus appears in various areas of the field of vision. The patient indicates when they can see the stimulus and the perimetrist then records the point where the stimulus was seen. These data points are used to determine the patient's visual field. | Analysis only includes subjects who completed study. | Posted | Mean | Standard Deviation | visual angle degrees^2 | up to 2 Months | eyes | eyes |
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| Primary | Virtual Reality (VR) Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 1 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 2 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 3 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 4 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 5 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 6 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 7 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. One subject did not complete the test day 8, so no data was collected for any subjects for this day. | Posted | Day 8 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 9 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 10 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. One subject did not complete the test day 11, so no data was collected for any subjects for this day. | Posted | Day 11 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 12 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 13 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 14 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 15 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 16 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 17 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 18 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 19 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 20 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. One subject did not complete the test day 21, so no data was collected for any subjects for this day. | Posted | Day 21 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 22 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. One subject did not complete the test day 23, so no data was collected for any subjects for this day. | Posted | Day 23 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. One subject did not complete the test day 24, so no data was collected for any subjects for this day. | Posted | Day 24 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 25 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 26 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. One subject did not complete the test day 27, so no data was collected for any subjects for this day. | Posted | Day 27 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. Data was not collected for 3 subjects due to logistical issues during COVID-19. One subject did not complete the test day 28, so no data was collected for any subjects for this day. | Posted | Day 28 | eyes | eyes |
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| Primary | Virtual Reality Visual Field Test--Mean Percent Correct | Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals. | Data was not collected for 3 subjects due to logistical issues during COVID-19. | Posted | Mean | Standard Deviation | percentage of correct trials | Day 29 | eyes | eyes |
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| Primary | Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | Posted | Mean | Standard Deviation | Percent of correct trials | Baseline | eyes | eyes |
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| Primary | Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | Posted | Mean | Standard Deviation | Percent of correct trials | up to 2 Months | eyes | eyes |
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| Primary | Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | Posted | Mean | Standard Deviation | Percent of correct trials | 3 Months | eyes | eyes |
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| Primary | Peripheral Visual Field Frame Test | The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested. | Due to study timeline constraints, only one subject completed the 6 month follow-up test. | Posted | Number | Percent of correct trials | 6 Months | eyes | eyes |
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| Secondary | National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Composite Score | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 month |
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| Secondary | NEI-VFQ-25--General Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Health Score is a subscale that measures the participant's self-report of their overall health. The score ranges from 0 to 100. A higher score denotes better perception of overall health. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--General Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Health Score is a subscale that measures the participant's self-report of their overall health. The score ranges from 0 to 100. A higher score denotes better perception of overall health. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--General Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Vision Score measures the participant's reported quality of vision. The score ranges from 0 to 100. A higher score denotes a better perception of vision | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--General Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Vision Score measures the participant's reported quality of vision. The score ranges from 0 to 100. A higher score denotes a better perception of vision | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Ocular Pain Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Ocular Pain Score Subscale measures reported pain or discomfort in and around the eyes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to ocular pain. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Ocular Pain Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Ocular Pain Score Subscale measures reported pain or discomfort in and around the eyes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to ocular pain. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Near Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Near Activities Score Subscale measures difficulty with performing near activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to near activities. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Near Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Near Activities Score Subscale measures difficulty with performing near activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to near activities. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Distance Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Distance Activities Score Subscale measures difficulty with performing distance activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to distance activities. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Distance Activities Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Distance Activities Score Subscale measures difficulty with performing distance activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to distance activities. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Social Functioning Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Social Functioning Score Subscale measures how vision difficulties affect social functioning. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to social functioning. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Social Functioning Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Social Functioning Score Subscale measures how vision difficulties affect social functioning. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to social functioning. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Mental Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Mental Health Score Subscale measures how much patients feel vision affects their mental health. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to mental health. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Mental Health Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Mental Health Score Subscale measures how much patients feel vision affects their mental health. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to mental health. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Role Difficulties Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Role Difficulties Score Subscale measures how limited by their vision patients feel they are. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to role difficulties. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Role Difficulties Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Role Difficulties Score Subscale measures how limited by their vision patients feel they are. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to role difficulties. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Dependency Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Dependency Score Subscale measures how much patients are dependent on other people due to their vision. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to dependency. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Dependency Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Dependency Score Subscale measures how much patients are dependent on other people due to their vision. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to dependency. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Driving Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Driving Score Subscale measures patients' reported difficulty with driving. The score ranges from 0 to 100. Patients who do not drive are not given a driving score. A higher score denotes better vision-specific quality of life related to driving. | Driving Score Mean and Standard deviation could not be calculated because only one subject was driving and only for the 3 month follow up. | Posted | Number | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Driving Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Driving Score Subscale measures patients' reported difficulty with driving. The score ranges from 0 to 100. Patients who do not drive are not given a driving score. A higher score denotes better vision-specific quality of life related to driving. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Color Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Color Vision Score Subscale measures how much difficulty patients have with using color vision to complete daily activities such as picking out clothes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to color vision. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Color Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Color Vision Score Subscale measures how much difficulty patients have with using color vision to complete daily activities such as picking out clothes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to color vision. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | NEI-VFQ-25--Peripheral Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Peripheral Vision Score Subscale measures how much difficulty patients have with their peripheral vision to complete daily activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to peripheral vision. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months, 3 months |
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| Secondary | NEI-VFQ-25--Peripheral Vision Score Subscale | The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Peripheral Vision Score Subscale measures how much difficulty patients have with their peripheral vision to complete daily activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to peripheral vision. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | score on a scale | 6 months |
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| Secondary | Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 2 months |
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| Secondary | VA LV VFQ-48--Item Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity. | Only one subject completed this outcome measure during the 3 month follow-up due to study timeline constraints. | Posted | Number | Score on a Scale | 3 months |
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| Secondary | VA LV VFQ-48--Item Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 (most difficult) and >=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | Score on a Scale | 6 months |
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| Secondary | VA LV VFQ-48--Composite Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 2 months |
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| Secondary | VA LV VFQ-48--Composite Score | he VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better. | Only one subject completed this outcome measure during the 3 month follow-up due to study timeline constraints. | Posted | Number | Score on a Scale | 3 months |
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| Secondary | VA LV VFQ-48--Composite Score | he VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is <= 2.34 and >=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better. | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | Score on a Scale | 6 months |
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| Secondary | VA LV VFQ-48--Reading Domain Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 2 months |
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| Secondary | VA LV VFQ-48--Reading Domain Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). | Only one subject completed this outcome measure during the 3 month follow-up due to study timeline constraints. | Posted | Number | Score on a Scale | 3 months |
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| Secondary | VA LV VFQ-48--Reading Domain Score | The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). | The study's start was delayed due to COVID so only 1 participant was able to complete the 6 month follow-up within the grant time frame. | Posted | Number | Score on a Scale | 6 months |
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| Other Pre-specified | Grating Acuity Test | Change in the percentage of correctly identified trials. | Not Posted | First visit after the completion of rehabilitation (1 or 2 months) | Participants |
| Other Pre-specified | Color Vision Test | Change in the percentage of correctly identified trials for each color. | Not Posted | First visit after the completion of rehabilitation (1 or 2 months) | Participants |
| Other Pre-specified | Shape Recognition Test | Change in the percentage of correctly identified trials. | Not Posted | First visit after the completion of rehabilitation (1 or 2 months) | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
Not provided
Not provided
Not provided
| D001766 |
| Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 45 Degrees |
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| 60 Degrees |
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| 75 Degrees |
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| 45 Degrees |
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| 60 Degrees |
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| 75 Degrees |
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| 45 Degrees |
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| 60 Degrees |
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| 75 Degrees |
|
| 45 Degrees |
|
| 60 Degrees |
|
| 75 Degrees |
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