Clinical trial NCT05049070: Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
Official title: A Prospective, Multicenter, Open Label Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction Assessed by GoEyes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractive Errors
Keywords: Refractive Errors
Myopia
Mobile Applications
Lead sponsor: 1800 Contacts, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: 90% Concordance for sphere power and cylinder power (monocular)
timeFrame: Baseline
measure: Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power
timeFrame: Baseline
measure: Monocular refractive outcomes
timeFrame: Baseline
measure: Monocular visual acuity
timeFrame: Baseline
measure: Proportion of out-of-range eye that are correctly excluded
timeFrame: Baseline
measure: Incidence of Adverse Events in Part 1
timeFrame: 21 days
measure: Incidence of Adverse Events in Part 2
timeFrame: 8 Days
Secondary outcomes:
measure: Descriptive statistics for sphere power and cylinder power (monocular)
timeFrame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
measure: Descriptive statistics for cylinder axis (monocular) stratified by cylinder power
timeFrame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
measure: Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately
timeFrame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
measure: Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined
timeFrame: Baseline
measure: Proportion of out of range eyes that are correctly excluded
timeFrame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
measure: Comparison of test and re-test measurements to Standard of Care (SOC) data
timeFrame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
measure: Rate of disagreement between GoEyes screening at home and in-clinic screening
timeFrame: Baseline
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Matrix Clinical Research
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Delray Beach
country: United States
facility: Segal Drug Trials
state: Florida
city: Louisville
country: United States
facility: Butchertown Clinical Trials
state: Kentucky
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Las Vegas
country: United States
facility: IMA Research
state: Nevada
city: Shelby
country: United States
facility: Core, Inc Vita Eye Clinic
state: North Carolina
city: Athens
country: United States
facility: Athens Eye Care
state: Ohio
city: Marysville
country: United States
facility: Optimed Research
state: Ohio
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Norfolk
country: United States
facility: Wagner Macula & Retina
state: Virginia
Study officials:
References: