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| Name | Class |
|---|---|
| Envision Solutions, LLC | OTHER_GOV |
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The purpose of this research is to assess the efficacy of a visual training task on reducing the size of a visual field deficit caused by brain damage in adults, and its ability to improve visual functions in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training in the blind field | Experimental | Training in the blind field using software |
|
| Training in the intact field | Experimental | Training in the intact field using software |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training in the blind field | Device | A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute, University of Miami Health Services | Miami | Florida | 33136 | United States | ||
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No subjects were excluded from the study between recruitment and randomization to assigned groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Training in the Blind Field | Training in the blind field using software Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. |
| FG001 | Training in the Intact Field | Training in the intact field using software Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Training in the Blind Field | Training in the blind field using software Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval. | All subjects that completed the assigned training were included in analysis. Each eye was analyzed independently for the primary outcome measure. | Posted | Mean | 95% Confidence Interval | decibels | 6 months | Eyes | Eyes |
|
Adverse event data were collected between initial enrollment and the conclusion of final assessment. For a given subject this period covered approximately 6 months.
Subjects were in open communication with study staff throughout their training period and invited to report any issues if they arose. At the conclusion of training subjects were interviewed and asked to report any adverse events they may have experienced.
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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 | Training in the Blind Field | Training in the blind field using software Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven E. Feldon, MD | University of Rochester | 585-273-1050 | Steven_Feldon@urmc.rochester.edu |
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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 | May 9, 2018 | Dec 1, 2020 | Prot_SAP_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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|
| Training in the intact field | Device | A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. |
|
| Flaum Eye Institute, University of Rochester Medical Center |
| Rochester |
| New York |
| 14642 |
| United States |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | United States |
| BG001 | Training in the Intact Field | Training in the intact field using software Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preliminary deficit size | The total area of the subject's deficit, as measured by Humphrey perimetry using a 24-2 testing pattern. This value was calculated by combining testing results from both eyes and interpolating between the tested points to a resolution of 0.1 deg of visual angle. Regions of the visual field with a pattern deviation value (as measured by the Humphrey perimeter) of less than -5 dB were then recorded as part of the deficit. The total area of these combined regions is reported here in square degrees of visual angle. | Mean | Standard Deviation | square degrees of visual angle |
|
| Patients with right sided deficits | Total number of patients with a visual deficit localized to the right hand side of the visual field. The number of patients with a left-side localized deficit is the difference between the total number of subjects and the right-side deficit count. | Count of Participants | Participants |
|
| Time since lesion | The length of time, in months, between the reported date of the stroke that induced visual loss in a patient and their enrollment in the study. | Median | Inter-Quartile Range | months |
|
| OG001 | Training in the Intact Field (Left Eye) | Training in the intact field using software Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. Final outcomes will be reported independently for Left and Right eyes. |
| OG002 | Training in the Blind Field (Right Eye) | Training in the blind field using software Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. Final outcomes will be reported independently for Left and Right eyes. |
| OG003 | Training in the Intact Field (Right Eye) | Training in the intact field using software Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. Final outcomes will be reported independently for Left and Right eyes. |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Training in the Intact Field | Training in the intact field using software Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D001766 |
| Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |