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

Conditions

• Refractive Errors

Eligibility Criteria

Sex

ALL

Age

18 Years - 39 Years

Healthy Volunteers

Not accepted

Interventions

• Mobile medical application to self administer a subjective refraction test — DIAGNOSTIC_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
• Standard of care refraction test — DIAGNOSTIC_TEST
  Standard of care subjective manifest refraction test performed by a healthcare professional

Study Details

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.

Key Dates

First listed

Sep 17, 2021

Start date

Sep 15, 2021

Status verified

Apr 2023

Primary completion

Jun 30, 2023

Completion

Jun 30, 2023

Study Design

Enrollment

349 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: GoEyes
  GoEyes Self administered refraction test + Standard of care refraction test

Primary Outcome Measure

90% Concordance for sphere power and cylinder power (monocular) [ Time Frame: Baseline ]

Central Contacts

• Karen Howse
  [email protected]

Locations (12)

Find similar trials in Beverly Hills, CA

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