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

Refractive Errors Clinical Trial

Official title:
A Prospective, Multicenter, Open Label Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction Assessed by GoEyes

Clinical Trial 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.

Clinical Trial Description

GoEyes is a Mobile Medical Application, which can be downloaded to a smartphone and is being developed as a self -administered subjective refraction examination that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals. The Study will be conducted in 2 parts; Part 1 and Part 2. Approximately 59 participants will be enrolled In Part 1. Part 1 participants will have a GoEyes refraction test in clinic on two separate days and will also have a standard of care refraction test performed by a health care provider and best corrected visual acuity assessments. Approximately 349 participants will be enrolled in Part 2. Part 2 participants will self administer the GoEyes test at home on 2 separate days and will also have in clinic standard of care refraction test performed by a health care provider and best corrected visual acuity assessments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05049070
Study type Interventional
Source 1800 Contacts, Inc.
Contact Karen Howse
Email khowse@luna.io
Status Recruiting
Phase N/A
Start date September 15, 2021
Completion date June 2023
View Details
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