Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

Not Applicable

Completed

• Conditions: Diabetic Retinopathy; Low Vision
• Interventions: Device: Eye4; Other: Placebo

• Registration Number: NCT05491746
• Lead Sponsor: Eyedaptic

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eye4	Eye4	This is the arm with the Eyedaptic Device
Baseline	Placebo	This is the placebo arm with the best correction the subject has

Primary Outcome Measures

Name	Time	Method
Visual acuity at distance	Day 1	Visual acuity at distance using Snellen Visual Acuity Chart

Secondary Outcome Measures

Name	Time	Method
Contrast sensitivity	Day 1	Contrast sensitivity measured using the Ridgevue contrast sensitivity scale
Visual acuity at near	Day 1	Visual acuity at near tested using Ridgevue Near Vision chart

Trial Locations

Locations (1)

Eyedaptic; 🇺🇸 Laguna Hills, California, United States