Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
Primary Purpose
Refractive Errors
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile medical application to self administer a subjective refraction test
Standard of care refraction test
Sponsored by
About this trial
This is an interventional diagnostic trial for Refractive Errors focused on measuring Refractive Errors, Myopia, Mobile Applications
Eligibility Criteria
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 -
Sites / Locations
- Matrix Clinical Research
- North Bay Eye Associates
- Empire Clinical Research
- Segal Drug TrialsRecruiting
- Butchertown Clinical Trials
- Tauber Eye Center
- IMA Research
- Core, Inc Vita Eye Clinic
- Athens Eye CareRecruiting
- Optimed ResearchRecruiting
- Total Eye CareRecruiting
- Wagner Macula & Retina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GoEyes
Arm Description
GoEyes Self administered refraction test + Standard of care refraction test
Outcomes
Primary Outcome Measures
90% Concordance for sphere power and cylinder power (monocular)
Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power
Monocular refractive outcomes
Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately)
Monocular visual acuity
Lower confidence limit of ≥95% (for right and left eyes combined)
Proportion of out-of-range eye that are correctly excluded
Incidence of Adverse Events in Part 1
Incidence of Adverse Events in Part 2
Secondary Outcome Measures
Descriptive statistics for sphere power and cylinder power (monocular)
Descriptive statistics for cylinder axis (monocular) stratified by cylinder power
Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately
Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined
Proportion of out of range eyes that are correctly excluded
Comparison of test and re-test measurements to Standard of Care (SOC) data
Rate of disagreement between GoEyes screening at home and in-clinic screening
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05049070
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
1800 Contacts, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Refractive Errors, Myopia, Mobile Applications
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The Best Corrected Visual Acuity (BCVA) assessor will be masked to GoEyes and Standard of Care refraction results.
Allocation
N/A
Enrollment
349 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GoEyes
Arm Type
Experimental
Arm Description
GoEyes Self administered refraction test + Standard of care refraction test
Intervention Type
Diagnostic Test
Intervention Name(s)
Mobile medical application to self administer a subjective refraction test
Other Intervention Name(s)
GoEyes
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard of care refraction test
Intervention Description
Standard of care subjective manifest refraction test performed by a healthcare professional
Primary Outcome Measure Information:
Title
90% Concordance for sphere power and cylinder power (monocular)
Time Frame
Baseline
Title
Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power
Time Frame
Baseline
Title
Monocular refractive outcomes
Description
Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately)
Time Frame
Baseline
Title
Monocular visual acuity
Description
Lower confidence limit of ≥95% (for right and left eyes combined)
Time Frame
Baseline
Title
Proportion of out-of-range eye that are correctly excluded
Time Frame
Baseline
Title
Incidence of Adverse Events in Part 1
Time Frame
21 days
Title
Incidence of Adverse Events in Part 2
Time Frame
8 Days
Secondary Outcome Measure Information:
Title
Descriptive statistics for sphere power and cylinder power (monocular)
Time Frame
Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Title
Descriptive statistics for cylinder axis (monocular) stratified by cylinder power
Time Frame
Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Title
Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately
Time Frame
Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Title
Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined
Time Frame
Baseline
Title
Proportion of out of range eyes that are correctly excluded
Time Frame
Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Title
Comparison of test and re-test measurements to Standard of Care (SOC) data
Time Frame
Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Title
Rate of disagreement between GoEyes screening at home and in-clinic screening
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Howse
Email
khowse@luna.io
Facility Information:
Facility Name
Matrix Clinical Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Empire Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Segal Drug Trials
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Butchertown Clinical Trials
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
IMA Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Core, Inc Vita Eye Clinic
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Athens Eye Care
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Optimed Research
City
Marysville
State/Province
Ohio
ZIP/Postal Code
43040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
Facility Name
Wagner Macula & Retina
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendon Quarnberg
12. IPD Sharing Statement
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Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
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