NCT05049070

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 349 (estimated)
• Sponsor: 1800 Contacts, Inc. · Industry
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-09-17
• Last updated: 2023-04-06

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study