Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
- Conditions
- Refractive Errors
- Interventions
- Diagnostic Test: Mobile medical application to self administer a subjective refraction testDiagnostic Test: Standard of care refraction test
- Registration Number
- NCT05049070
- Lead Sponsor
- 1800 Contacts, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 349
- 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 -
- 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 -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GoEyes Mobile medical application to self administer a subjective refraction test GoEyes Self administered refraction test + Standard of care refraction test GoEyes Standard of care refraction test GoEyes Self administered refraction test + Standard of care refraction test
- Primary Outcome Measures
Name Time Method Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power Baseline Proportion of out-of-range eye that are correctly excluded Baseline Incidence of Adverse Events in Part 1 21 days Monocular visual acuity Baseline Lower confidence limit of ≥95% (for right and left eyes combined)
90% Concordance for sphere power and cylinder power (monocular) Baseline Incidence of Adverse Events in Part 2 8 Days Monocular refractive outcomes Baseline Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately)
- Secondary Outcome Measures
Name Time Method Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined Baseline 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) 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) Comparison of test and re-test measurements to Standard of Care (SOC) data Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2) Rate of disagreement between GoEyes screening at home and in-clinic screening Baseline 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 sphere power and cylinder power (monocular) Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Trial Locations
- Locations (12)
Matrix Clinical Research
🇺🇸Beverly Hills, California, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
Butchertown Clinical Trials
🇺🇸Louisville, Kentucky, United States
Segal Drug Trials
🇺🇸Delray Beach, Florida, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Athens Eye Care
🇺🇸Athens, Ohio, United States
Core, Inc Vita Eye Clinic
🇺🇸Shelby, North Carolina, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States
Optimed Research
🇺🇸Marysville, Ohio, United States
Wagner Macula & Retina
🇺🇸Norfolk, Virginia, United States
IMA Research
🇺🇸Las Vegas, Nevada, United States