NCT05491746

Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Eyedaptic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Retinopathy
• Low Vision

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2022-08-08
• Last updated: 2023-02-15

Locations

1 site across 1 country: United States