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

NCT05049070 | Unknown FDA Device

• 1 other identifier: QAD-079
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 12

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

Keywords

Refractive Errors; Myopia; Mobile Applications

Outcome Measures

Primary Outcomes (7)

• 90% Concordance for sphere power and cylinder power (monocular)

  Baseline

• Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power

  Baseline

• Monocular refractive outcomes

  Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately)

  Baseline

• Monocular visual acuity

  Lower confidence limit of ≥95% (for right and left eyes combined)

  Baseline

• Proportion of out-of-range eye that are correctly excluded

  Baseline

• Incidence of Adverse Events in Part 1

  21 days

• Incidence of Adverse Events in Part 2

  8 Days

Secondary Outcomes (7)

• Descriptive statistics for sphere power and cylinder power (monocular)

  Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)

• Descriptive statistics for cylinder axis (monocular) stratified by cylinder power

  Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)

• Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately

  Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)

• Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined

  Baseline

• Proportion of out of range eyes that are correctly excluded

  Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)

Study Arms (1)

GoEyes

EXPERIMENTAL

GoEyes Self administered refraction test + Standard of care refraction test

Diagnostic Test: Mobile medical application to self administer a subjective refraction test; Diagnostic Test: Standard of care refraction test

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

Also known as: GoEyes

GoEyes

Standard of care refraction test DIAGNOSTIC_TEST

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

GoEyes

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• 1800 Contacts, Inc.: lead

Study Sites (12)

Matrix Clinical Research

Beverly Hills, California, 90210, United States

NOT YET RECRUITING

North Bay Eye Associates

Petaluma, California, 94954, United States

NOT YET RECRUITING

Empire Clinical Research

Pomona, California, 91767, United States

NOT YET RECRUITING

Segal Drug Trials

Delray Beach, Florida, 33484, United States

RECRUITING

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

NOT YET RECRUITING

Tauber Eye Center

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

IMA Research

Las Vegas, Nevada, 89102, United States

NOT YET RECRUITING

Core, Inc Vita Eye Clinic

Shelby, North Carolina, 28150, United States

NOT YET RECRUITING

Athens Eye Care

Athens, Ohio, 45701, United States

RECRUITING

Optimed Research

Marysville, Ohio, 43040, United States

RECRUITING

Total Eye Care

Memphis, Tennessee, 38119, United States

RECRUITING

Wagner Macula & Retina

Norfolk, Virginia, 23454, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Karen Howse

CONTACT

khowse@luna.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The Best Corrected Visual Acuity (BCVA) assessor will be masked to GoEyes and Standard of Care refraction results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 17, 2021
• Study Start: September 15, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

US (12)