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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Refractive Errors

Intervention / Treatment
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* Diagnostic Test: Mobile medical application to self administer a subjective refraction test
* Diagnostic Test: Standard of care refraction test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GoEyes<br>GoEyes Self administered refraction test + Standard of care refraction test | Diagnostic Test: Mobile medical application to self administer a subjective refraction test<br>* 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<br>* Other names: GoEyes;Diagnostic Test: Standard of care refraction test<br>* Standard of care subjective manifest refraction test performed by a healthcare professional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractive Errors, Myopia, Mobile Applications