Diabetic Retinopathy, Macular Degeneration, Age-Related
Conditions
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).
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.
Interventions
DEVICEHead-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).
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will wear a head mounted visual enhancement device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Vision Aided by a Head Mounted Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized White/Hispanic | 1 Participants |
| Race/Ethnicity, Customized White/Non-HIspanic | 6 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: 10 minutes post intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vision Aided by a Head Mounted Device | Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device | BCVNA Unable to read | 1 Participants |
| Vision Aided by a Head Mounted Device | Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device | BCVNA <=20/50 | 2 Participants |
| Vision Aided by a Head Mounted Device | Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device | BCVNA <=20/150 | 1 Participants |
| Vision Aided by a Head Mounted Device | Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device | BCVNA > 20/150 | 4 Participants |
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.
Time frame: 5 minutes post intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vision Aided by a Head Mounted Device | Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device | BCVA unable to read | 1 Participants |
| Vision Aided by a Head Mounted Device | Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device | BCVA </= 20/50 | 4 Participants |
| Vision Aided by a Head Mounted Device | Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device | BCVA </= 20/80 | 2 Participants |
| Vision Aided by a Head Mounted Device | Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device | BCVA > 20/350 | 1 Participants |
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.
Time frame: Day 1 up to 1 minute post intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vision Aided by a Head Mounted Device | Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. | Able to distinguish expressions w/ device | 4 Participants |
| Vision Aided by a Head Mounted Device | Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. | Unable to distinguish expressions w/ device | 4 Participants |
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.
Time frame: Day 1 up to 6 minutes post intervention
Population: Participants were asked to read a passage 98 words within a 3 min. time period
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vision Aided by a Head Mounted Device | Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device | Completed reading assignment with device | 4 Participants |
| Vision Aided by a Head Mounted Device | Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device | Did not complete reading assignment with device | 4 Participants |
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.
Time frame: Initial Baseline and 3 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vision Aided by a Head Mounted Device | Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device | Identify items with device > 15 sec w/ headset | 3 Participants |
| Vision Aided by a Head Mounted Device | Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device | Cannot identify items w/ headset | 2 Participants |
| Vision Aided by a Head Mounted Device | Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device | Identify items with device < 15 sec w/ headset | 3 Participants |