Visual Enhancement Device in Low Vision Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Head Mounted Electronic Visual Enhancement Device in Low Vision Patients

Conditions
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Macular Degeneration, Age-Related, Diabetic Retinopathy

Intervention / Treatment
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* Device: Head-Mounted Visual Enhancement Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will wear a head mounted visual enhancement device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vision Aided by a Head Mounted Device<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |