Diabetic Retinopathy Clinical Trial
— DRTARESOfficial title:
Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
NCT number | NCT05491746 |
Other study ID # | 2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | October 1, 2022 |
Verified date | February 2023 |
Source | Eyedaptic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Eyedaptic | Laguna Hills | California |
Lead Sponsor | Collaborator |
---|---|
Eyedaptic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual acuity at distance | Visual acuity at distance using Snellen Visual Acuity Chart | Day 1 | |
Secondary | Visual acuity at near | Visual acuity at near tested using Ridgevue Near Vision chart | Day 1 | |
Secondary | Contrast sensitivity | Contrast sensitivity measured using the Ridgevue contrast sensitivity scale | Day 1 |
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