Evergaze: Visual Enhancement Device in Low Vision Patients
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Vision Aided by a Head Mounted Device 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. |
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).
|
Outcome Measures
Primary Outcome Measures
- Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device [5 minutes post intervention]
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.
- Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device [10 minutes post intervention]
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.
- Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device [Day 1 up to 6 minutes post intervention]
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.
- Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. [Day 1 up to 1 minute post intervention]
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.
- Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device [Initial Baseline and 3 minutes]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient of any sex, race, or ethnicity who are 18 years of age or older. Spanish speaking patients will be encouraged to participate, Spanish forms will be available to review and execute.
-
Patient willing to review, understand and sign written informed consent. Parents or legal guardians will consent on behalf of minors.
-
Written authorization for use or release of health and research study information.
-
Patient who volunteers is suffering from a posterior segment ophthalmic disorder including AMD and/or Diabetic Retinopathy and visual acuity from 20/60 to 20/400 in the better seeing eye.
Exclusion Criteria:
-
Subjects will be excluded if they are less than 18 years of age.
-
Subjects will not be considered for this research study if they will not review and execute the informed consent form.
-
During the screening process, subjects will be excluded from further consideration if they are identified with having a potential ophthalmic diagnosis other than age-related macular degeneration or diabetic macular edema that could be negatively affecting the visual testing.
-
ETDRS Visual Acuity better than 20/60 or worse than 20/400
-
During screening, subjects will be disqualified from further assessment if it is determined that their refractive error is outside of the -5.00 to +5.00 D corrective range.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
- Principal Investigator: Rafael Ufret-Vincenty, MD, UTSW Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- STU 012014-015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Use of Head Mounted Device |
|---|---|
| Arm/Group Description | 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) |
| Period Title: Overall Study | |
| STARTED | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Vision Aided by a Head Mounted Device |
|---|---|
| Arm/Group Description | 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). |
| Overall Participants | 8 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
8
100%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
87.5%
|
| Male |
1
12.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Black |
1
12.5%
|
| White/Hispanic |
1
12.5%
|
| White/Non-HIspanic |
6
75%
|
Outcome Measures
| Title | Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device |
|---|---|
| Description | 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. |
| Time Frame | 5 minutes post intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vision Aided by a Head Mounted Device |
|---|---|
| Arm/Group Description | ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions. 1. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device. |
| Measure Participants | 8 |
| BCVA unable to read |
1
12.5%
|
| BCVA </= 20/50 |
4
50%
|
| BCVA </= 20/80 |
2
25%
|
| BCVA > 20/350 |
1
12.5%
|
| Title | Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device |
|---|---|
| Description | 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. |
| Time Frame | 10 minutes post intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vision Aided by a Head Mounted Device |
|---|---|
| Arm/Group Description | ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected near visual acuity (BCNVA) will be determined for each participant using the following conditions. 1. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device. |
| Measure Participants | 8 |
| BCVNA Unable to read |
1
12.5%
|
| BCVNA <=20/50 |
2
25%
|
| BCVNA <=20/150 |
1
12.5%
|
| BCVNA > 20/150 |
4
50%
|
| Title | Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device |
|---|---|
| Description | 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. |
| Time Frame | Day 1 up to 6 minutes post intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants were asked to read a passage 98 words within a 3 min. time period |
| Arm/Group Title | Vision Aided by a Head Mounted Device |
|---|---|
| Arm/Group Description | Reading speed is measured by using a standard paragraph. English Paragraph Reference: 3-Minute Reading Assessments, Rasinski TV and Padak N, 2005. Scholastic Inc., NY. This outcome examines change in reading speed of the participant in two separate conditions: 1. Baseline reading - no use of the head-mounted electronic visual enhancement device. and 2. reading using head-mounted electronic visual enhancement device. |
| Measure Participants | 8 |
| Completed reading assignment with device |
4
50%
|
| Did not complete reading assignment with device |
4
50%
|
| Title | Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. |
|---|---|
| Description | 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. |
| Time Frame | Day 1 up to 1 minute post intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vision Aided by a Head Mounted Device |
|---|---|
| Arm/Group Description | 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 will be determined for each participant using the following conditions. 1. Using the head-mounted electronic visual enhancement device. 2. Without using the head-mounted electronic visual enhancement device. |
| Measure Participants | 8 |
| Able to distinguish expressions w/ device |
4
50%
|
| Unable to distinguish expressions w/ device |
4
50%
|
| Title | Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device |
|---|---|
| Description | 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. |
| Time Frame | Initial Baseline and 3 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vision Aided by a Head Mounted Device |
|---|---|
| Arm/Group Description | Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded. Data will record change in response speed to identify shapes and objects under 2 conditions; 1. with the participant using the head-mounted electronic visual enhancement device and 2. with the participant not using the head-mounted electronic visual enhancement device . |
| Measure Participants | 8 |
| Identify items with device < 15 sec w/ headset |
3
37.5%
|
| Identify items with device > 15 sec w/ headset |
3
37.5%
|
| Cannot identify items w/ headset |
2
25%
|
Adverse Events
| Time Frame | 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. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Use of Head Mounted Device | |
| Arm/Group Description | 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) | |
All Cause Mortality |
||
| Use of Head Mounted Device | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Serious Adverse Events |
||
| Use of Head Mounted Device | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Use of Head Mounted Device | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Peter Chen |
|---|---|
| Organization | UT Southwestern Medical Center |
| Phone | 12146283837 |
| peter.chen@utsouthwestern.edu |
- STU 012014-015