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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05491746
Other study ID # 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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