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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049070
• Other study ID #: QAD-079
• Status: Recruiting
• Phase: N/A
• 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
• 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 -

Related Conditions & MeSH terms

• Refractive Errors

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