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OpenTrials
Completed

NCT Number: NCT05491746

Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Low Vision Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders Vision, Low

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eyedaptic

Laguna Hills, California, 92653, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye4

Device

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

Placebo

Other

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

Primary outcomes

  1. Visual acuity at distance

    Time frame: Day 1

    Visual acuity at distance using Snellen Visual Acuity Chart

Secondary outcomes

  1. Visual acuity at near

    Time frame: Day 1

    Visual acuity at near tested using Ridgevue Near Vision chart

  2. Contrast sensitivity

    Time frame: Day 1

    Contrast sensitivity measured using the Ridgevue contrast sensitivity scale

Sponsors and collaborators

Lead sponsor

Eyedaptic

Industry

Registry information

Acronym: DRTARES

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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