Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

NCT05491746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Eyedaptic

    lead INDUSTRY

Principal Investigators

  • Mitul Mehta, MD · Eyedaptic

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491746 on ClinicalTrials.gov