NCT05491746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

August 1, 2022

Last Update Submit

February 14, 2023

Conditions

Diabetic RetinopathyLow Vision

Outcome Measures

Primary Outcomes (1)

  • Visual acuity at distance

    Visual acuity at distance using Snellen Visual Acuity Chart

    Day 1

Secondary Outcomes (2)

  • Visual acuity at near

    Day 1

  • Contrast sensitivity

    Day 1

Study Arms (2)

Eye4

EXPERIMENTAL

This is the arm with the Eyedaptic Device

Device: Eye4

Baseline

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Eye4DEVICE

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

Eye4
PlaceboOTHER

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

Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Best correct visual acuity in the better seeing eye between 20/60 and 20/800
  • History of diabetic retinopathy

You may not qualify if:

  • Unable to complete the visit
  • Unable to give a reliable measurement of vision
  • Unable to comfortably wear the glasses for at least 60 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eyedaptic

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Conditions

Diabetic RetinopathyVision, Low

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mitul Mehta, MD

    Eyedaptic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 8, 2022

Study Start

July 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)