Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be a prospective, non-randomized study of low-vision individuals diagnosed with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS visual acuity from 20/60 to 20/400 in both eyes from the University of Texas - Southwestern (UTSW) Medical Center at Dallas. Specifically, the primary objective of this testing is to establish the benefits of a wide field-of-view (FOV) monocular head-mounted visual enhancement device display (HMD), aiding the most degraded eye, as compared to best corrected visual acuity with glasses. It should be noted that in this approach, the HMD incorporates a camera, mounted coaxially with the visual axis of the eye with worse vision, and also image-enhancing or correction algorithms. Following review and execution of the informed consent, each subject will undergo an examination of their eyes, including: 1) ETDRS Best-corrected distance visual acuity; 2) Best-corrected near visual acuity; 3) Tests based on questions 5,6,7 and 11 of the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25).
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. All testing will be used for research purposes. There will be an 1) Early Treatment Diabetic Retinopathy Study visual acuity test, 2) near vision test, 3) Testing based on questions 5,6,7, and 11 of the National Eye Institute 25 item visual function questionnaire, (NEI VFQ-25) which includes a speed reading test, identifying objects, physically taking them and returning the items to correct original placement, once with glasses only, once with the head mounted visual device placed over the worst eye visually. There will also be an video tracks showing a conversation between 2 individuals - Subjects will be queried about the facial expressions of the actors during the conversation. The device is a wide field of view (FOV) monocular head-mounted visual enhancement device (HMD). The HMD has a camera mounted coaxially with the visual axis of the worse vision eye, and also image enhancing or correction algorithms. There are breaks planned between testing on the visual function exam portion of the NEI-25.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vision Aided by a Head Mounted Device | Other | A Head-Mounted Visual Enhancement Device developed by Evergaze Technology LLC has designed an electronic visual enhancement device that is compact and similar to glasses. It will be powered by a battery pack connected to the device. The electronic display will be affixed over only one of the user's eyes. The vision through the unobstructed eye will aid with the subject's balance and spatial orientation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head-Mounted Visual Enhancement Device | Device | Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black & white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use). |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device | ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | 5 minutes post intervention |
| Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device | ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | 10 minutes post intervention |
| Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device | Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY. | Day 1 up to 6 minutes post intervention |
| Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. | Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | Day 1 up to 1 minute post intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rafael Ufret-Vincenty, MD | UTSW Medical Center | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Use of Head Mounted Device | Evergaze has developed a head-mounted visual enhancement device for low-vision patients. Patients will be non-randomized individuals diagnosed with either Retinal Degeneration or diabetic macular edema with ETDRS (Early Treatment Diabetic Retinopathy Study) VA 20/60 to 20/400. The device will be placed over the most degraded eye incorporating a camera, mounted coaxially with the visual axis of the eye with the worse vision. Incorporation of a video recording of head and eye movement with the head mounted device is being included for any functionality improvements to be made. Then each subject will undergo complete examination of their eyes, including ETDRS VA, distance and near along with Questions 5,6,7,and 11 of the NEI (National Eye Institute) 25 item visual function questionnaire (NEI VFQ 25) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants performing skills without the head mounted visual aid device will be provide the baseline values for each aspect of this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vision Aided by a Head Mounted Device | Head-Mounted Visual Enhancement Device: Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black & white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device | ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | Posted | Count of Participants | Participants | 5 minutes post intervention |
|
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Use of Head Mounted Device | Evergaze has developed a head-mounted visual enhancement device for low-vision patients. Patients will be non-randomized individuals diagnosed with either Retinal Degeneration or diabetic macular edema with ETDRS (Early Treatment Diabetic Retinopathy Study) VA 20/60 to 20/400. The device will be placed over the most degraded eye incorporating a camera, mounted coaxially with the visual axis of the eye with the worse vision. Incorporation of a video recording of head and eye movement with the head mounted device is being included for any functionality improvements to be made. Then each subject will undergo complete examination of their eyes, including ETDRS VA, distance and near along with Questions 5,6,7,and 11 of the NEI (National Eye Institute) 25 item visual function questionnaire (NEI VFQ 25) |
Not provided
Not provided
This study had a small enrollment of 8 initial pilot study participants that were tested but not analyzed due to an early termination of the study. Termination was due to irreconcilable differences regarding intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Chen | UT Southwestern Medical Center | 12146283837 | peter.chen@utsouthwestern.edu |
Not provided
| 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 | Oct 10, 2016 | Sep 22, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
Not provided
Not provided
Participants will wear a head mounted visual enhancement device.
Not provided
Not provided
Not provided
Not provided
|
| Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device | Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | Initial Baseline and 3 minutes |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Rows represent Race and Ethnicity. | Count of Participants | Participants |
|
|
|
| Primary | Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device | ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | Posted | Count of Participants | Participants | 10 minutes post intervention |
|
|
|
| Primary | Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device | Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY. | Participants were asked to read a passage 98 words within a 3 min. time period | Posted | Count of Participants | Participants | Day 1 up to 6 minutes post intervention |
|
|
|
| Primary | Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. | Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | Posted | Count of Participants | Participants | Day 1 up to 1 minute post intervention |
|
|
|
| Primary | Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device | Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. | Posted | Count of Participants | Participants | Initial Baseline and 3 minutes |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| BCVNA > 20/150 |
|