Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

NCT ID: NCT05491746

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-10-01

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.

Conditions

Diabetic Retinopathy; Low Vision

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Eye4

This is the arm with the Eyedaptic Device

Group Type: EXPERIMENTAL

Eye4

Intervention Type: DEVICE

Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity.

Baseline

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

This is the patient's best corrected vision with or without glasses/contact lenses

Interventions

Eye4

Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity.

Intervention Type: DEVICE

Placebo

This is the patient's best corrected vision with or without glasses/contact lenses

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eyedaptic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitul Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Eyedaptic

Locations

Eyedaptic

Laguna Hills, California, United States

Countries

United States

Other Identifiers

2

Identifier Type: -

Identifier Source: org_study_id