Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

Diabetic Retinopathy Clinical Trial

— DRTARES  

Official title:

Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05491746
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2023
• Source: Eyedaptic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Low Vision
• Retinal Diseases
• Vision, Low

Intervention

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

Locations

Country	Name	City	State
United States	Eyedaptic	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Eyedaptic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity at distance	Visual acuity at distance using Snellen Visual Acuity Chart	Day 1
Secondary	Visual acuity at near	Visual acuity at near tested using Ridgevue Near Vision chart	Day 1
Secondary	Contrast sensitivity	Contrast sensitivity measured using the Ridgevue contrast sensitivity scale	Day 1