Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

Study Overview
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Brief Summary
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Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Our study is going to look at an FDA Class 1 Exempted visual aid that uses augmented reality to help people see better.

Detailed Description
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In this study subjects will have their best corrected visual acuity and contrast sensitivity compared to their best vision and contrast with the Eyedaptic device. The Eyedaptic device is an FDA 510(k) Class 1 Exempt device as it is a visual aid. This is a pilot study to determine whether subjects with diabetic retinopathy associated vision loss obtain a benefit with augmented reality vision. Subjects will receive a manifest refraction. When subjects have their optimal corrective lenses, the subjects' vision will be tested with their corrective lenses alone and again using the Eyedaptic device. This will be a single visit study, with no follow up.

Official Title
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Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

Conditions
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Diabetic Retinopathy, Low Vision

Intervention / Treatment
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* Device: Eye4
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Best correct visual acuity in the better seeing eye between 20/60 and 20/800 History of diabetic retinopathy Exclusion Criteria: Unable to complete the visit Unable to give a reliable measurement of vision Unable to comfortably wear the glasses for at least 60 minutes

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye4<br>This is the arm with the Eyedaptic Device | Device: Eye4<br>* Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity.<br>|
| Placebo Comparator: Baseline<br>This is the placebo arm with the best correction the subject has | Other: Placebo<br>* This is the patient's best corrected vision with or without glasses/contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity at distance | Visual acuity at distance using Snellen Visual Acuity Chart | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity at near | Visual acuity at near tested using Ridgevue Near Vision chart | Day 1 | 
| Contrast sensitivity | Contrast sensitivity measured using the Ridgevue contrast sensitivity scale | Day 1 |