Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
NCT05491746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-02-15
Summary
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.
Conditions
- Diabetic Retinopathy
- Low Vision
Interventions
- DEVICE
-
Eye4
Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity.
- OTHER
-
Placebo
This is the patient's best corrected vision with or without glasses/contact lenses
Sponsors & Collaborators
-
Eyedaptic
lead INDUSTRY
Principal Investigators
-
Mitul Mehta, MD · Eyedaptic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2022-10-01
- Completion
- 2022-10-01
Countries
- United States
Study Locations
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