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DRTARES: Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

Sponsor
Eyedaptic (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05491746
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Eye4
  • Other: Placebo
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eye4

This is the arm with the Eyedaptic Device

Device: Eye4
Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity.
Placebo Comparator: Baseline

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

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

Outcome Measures

Primary Outcome Measures

  1. Visual acuity at distance [Day 1]

    Visual acuity at distance using Snellen Visual Acuity Chart

Secondary Outcome Measures

  1. Visual acuity at near [Day 1]

    Visual acuity at near tested using Ridgevue Near Vision chart

  2. Contrast sensitivity [Day 1]

    Contrast sensitivity measured using the Ridgevue contrast sensitivity scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eyedaptic Laguna Hills California United States 92653

Sponsors and Collaborators

  • Eyedaptic

Investigators

  • Principal Investigator: Mitul Mehta, MD, Eyedaptic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eyedaptic
ClinicalTrials.gov Identifier:
NCT05491746
Other Study ID Numbers:
  • 2
First Posted:
Aug 8, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vision, Low
Retinal Diseases
Diabetic Retinopathy

Study Results

No Results Posted as of Aug 8, 2022