Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study (DRTARES)

Eyedaptic

Status: Completed

Conditions: Low Vision; Diabetic Retinopathy

Treatments: Other: Placebo; Device: Eye4

Study type: Interventional

Funder types: Industry

Identifiers

NCT05491746

2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Eye4

Experimental group

Description:

This is the arm with the Eyedaptic Device

Treatment:

Device: Eye4

Baseline

Placebo Comparator group

Description:

This is the placebo arm with the best correction the subject has

Treatment:

Other: Placebo