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

NCT ID: NCT05049070

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-06-30

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.

Conditions

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Refractive Errors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The Best Corrected Visual Acuity (BCVA) assessor will be masked to GoEyes and Standard of Care refraction results.

Study Groups

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GoEyes

GoEyes Self administered refraction test + Standard of care refraction test

Group Type EXPERIMENTAL

Mobile medical application to self administer a subjective refraction test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

Standard of care subjective manifest refraction test performed by a healthcare professional

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Standard of care refraction test

Standard of care subjective manifest refraction test performed by a healthcare professional

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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GoEyes

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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1800 Contacts, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Matrix Clinical Research

Beverly Hills, California, United States

Site Status NOT_YET_RECRUITING

North Bay Eye Associates

Petaluma, California, United States

Site Status NOT_YET_RECRUITING

Empire Clinical Research

Pomona, California, United States

Site Status NOT_YET_RECRUITING

Segal Drug Trials

Delray Beach, Florida, United States

Site Status RECRUITING

Butchertown Clinical Trials

Louisville, Kentucky, United States

Site Status NOT_YET_RECRUITING

Tauber Eye Center

Kansas City, Missouri, United States

Site Status NOT_YET_RECRUITING

IMA Research

Las Vegas, Nevada, United States

Site Status NOT_YET_RECRUITING

Core, Inc Vita Eye Clinic

Shelby, North Carolina, United States

Site Status NOT_YET_RECRUITING

Athens Eye Care

Athens, Ohio, United States

Site Status RECRUITING

Optimed Research

Marysville, Ohio, United States

Site Status RECRUITING

Total Eye Care

Memphis, Tennessee, United States

Site Status RECRUITING

Wagner Macula & Retina

Norfolk, Virginia, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Karen Howse

Role: CONTACT

Facility Contacts

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Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Brendon Quarnberg

Role: primary

Other Identifiers

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QAD-079

Identifier Type: -

Identifier Source: org_study_id

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