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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05049070
Other study ID # QAD-079
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date June 2023

Study information

Verified date April 2023
Source 1800 Contacts, Inc.
Contact Karen Howse
Email khowse@luna.io
Is FDA regulated No
Health authority
Study type Interventional

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.


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 information / eligibility

Status Recruiting
Enrollment 349
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 39 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Athens Eye Care Athens Ohio
United States Matrix Clinical Research Beverly Hills California
United States Segal Drug Trials Delray Beach Florida
United States Tauber Eye Center Kansas City Missouri
United States IMA Research Las Vegas Nevada
United States Butchertown Clinical Trials Louisville Kentucky
United States Optimed Research Marysville Ohio
United States Total Eye Care Memphis Tennessee
United States Wagner Macula & Retina Norfolk Virginia
United States North Bay Eye Associates Petaluma California
United States Empire Clinical Research Pomona California
United States Core, Inc Vita Eye Clinic Shelby North Carolina

Sponsors (1)

Lead Sponsor Collaborator
1800 Contacts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 90% Concordance for sphere power and cylinder power (monocular) Baseline
Primary Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power Baseline
Primary Monocular refractive outcomes Lower confidence limit of = 90% for concordance (for right and left eyes separately) Baseline
Primary Monocular visual acuity Lower confidence limit of =95% (for right and left eyes combined) Baseline
Primary Proportion of out-of-range eye that are correctly excluded Baseline
Primary Incidence of Adverse Events in Part 1 21 days
Primary Incidence of Adverse Events in Part 2 8 Days
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined Baseline
Secondary 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)
Secondary 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)
Secondary Rate of disagreement between GoEyes screening at home and in-clinic screening Baseline
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