Recruiting

Observational Study

Sponsor:

1800 Contacts, Inc.

Code:

NCT05049070

Conditions

Refractive Errors

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Mobile medical application to self administer a subjective refraction test

Standard of care refraction test

Study Details

Brief 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

Study ID

NCT05049070

Start date

Sep 15, 2021

Status verified date

Apr, 2023

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males or females aged 18-39 years who currently wear glasses and/or soft contact lenses to correct refractive error
2. Normal color vision
3. Able to use both hands at the same time and to hear, understand and verbally respond to audio instructions
4. Have single vision lenses only
5. Able to provide informed consent -

Exclusion Criteria:

1. Have any ongoing disease or ocular condition other than refractive error
2. Have a history of permanent vison loss
3. Have a neurological condition affecting vision
4. Have worn glasses since age 6 or younger
5. Have a prism in their prescription
6. Use Rigid gas permeable lenses or OrthoK lenses
7. Have had laser refractive surgery or any other eye surgery
8. Use prescription eye drops -

Study Design

Enrollment

349 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: GoEyes

GoEyes Self administered refraction test + Standard of care refraction test

Interventions

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

Standard of care refraction test

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

Primary outcome measure

  • 90% Concordance for sphere power and cylinder power (monocular) [ Time Frame: Baseline ]
  • Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power [ Time Frame: Baseline ]
  • Monocular refractive outcomes [ Time Frame: Baseline ]
  • Monocular visual acuity [ Time Frame: Baseline ]
  • Proportion of out-of-range eye that are correctly excluded [ Time Frame: Baseline ]
  • Incidence of Adverse Events in Part 1 [ Time Frame: 21 days ]
  • Incidence of Adverse Events in Part 2 [ Time Frame: 8 Days ]

Central Contacts and Locations

Central contacts

Karen Howse

khowse@luna.io

Locations

Segal Drug Trials

Recruiting

Delray Beach, Florida, United States, 33484

Athens Eye Care

Recruiting

Athens, Ohio, United States, 45701

Optimed Research

Recruiting

Marysville, Ohio, United States, 43040

Total Eye Care

Recruiting

Memphis, Tennessee, United States, 38119

More Information

Sponsor

1800 Contacts, Inc.

Last update posted

Apr 6, 2023

Last verified

Apr, 2023

Keywords

  • Refractive Errors
  • Myopia
  • Mobile Applications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by 1800 Contacts, Inc. on 2023-04-06.