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Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction

NCT05049070 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2023-04-06

No results posted yet for this study

Summary

This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health care provider, in subjects who have no known ocular disease or condition other than refractive error.

Conditions

  • Refractive Errors

Interventions

DIAGNOSTIC_TEST

Mobile medical application to self administer a subjective refraction test

GoEyes is a software as a medical device and mobile medical application, which is downloaded to a smartphone and is a self-administered subjective refraction test that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals

DIAGNOSTIC_TEST

Standard of care refraction test

Standard of care subjective manifest refraction test performed by a healthcare professional

Sponsors & Collaborators

  • 1800 Contacts, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05049070 on ClinicalTrials.gov