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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors
• Intervention / Treatment: Diagnostic test: Mobile medical application to self administer a subjective refraction test; Diagnostic test: Standard of care refraction test

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.

• Study Type: Interventional
• Enrollment (Anticipated): 349
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Howse; Email: khowse@luna.io

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Not yet recruiting
      • Matrix Clinical Research
      • Contact: Brendon Quarnberg
    • Petaluma, California, United States, 94954
      • Not yet recruiting
      • North Bay Eye Associates
      • Contact: Brendon Quarnberg
    • Pomona, California, United States, 91767
      • Not yet recruiting
      • Empire Clinical Research
      • Contact: Brendon Quarnberg
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Recruiting
      • Segal Drug Trials
      • Contact: Brendon Quarnberg
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Not yet recruiting
      • Butchertown Clinical Trials
      • Contact: Brendon Quarnberg
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Not yet recruiting
      • Tauber Eye Center
      • Contact: Brendon Quarnberg
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Not yet recruiting
      • IMA Research
      • Contact: Brendon Quarnberg
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Not yet recruiting
      • Core, Inc Vita Eye Clinic
      • Contact: Brendon Quarnberg
  • Ohio
    • Athens, Ohio, United States, 45701
      • Recruiting
      • Athens Eye Care
      • Contact: Brendon Quarnberg
    • Marysville, Ohio, United States, 43040
      • Recruiting
      • Optimed Research
      • Contact: Brendon Quarnberg
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Recruiting
      • Total Eye Care
      • Contact: Brendon Quarnberg
  • Virginia
    • Norfolk, Virginia, United States, 23454
      • Not yet recruiting
      • Wagner Macula & Retina
      • Contact: Brendon Quarnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GoEyes; GoEyes Self administered refraction test + Standard of care refraction test

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; Other Names: GoEyes; Diagnostic test: Standard of care refraction test; Standard of care subjective manifest refraction test performed by a healthcare professional

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: 1800 Contacts, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Myopia; Mobile Applications; Refractive Errors
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: QAD-079

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes