Comparison of Visual Acuity Performed in Office Versus In Residence

NCT ID: NCT05250986

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 325 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2022-09-01

Brief Summary

GoCheck has developed and deployed a home-based visual acuity test that may be used in-office or in residence. The test methodology utilizes modified ATS and ETDRS protocols with Sloan optotypes, crowding bars and sophisticated algorithms. The objective of this study is to determine if the results of the GoCheck visual acuity test performed in an office setting correlate to the same testing when implemented in the residence

Detailed Description

To address the increasing needs for remote patient assessment, GoCheck has developed and deployed a home-based visual acuity test that may be used in-office or in residence, to meet the changing needs of providers visit time allocation, as well as presenting a standardized form of visual acuity centered around clinically-validated approaches.

The test methodology utilizes modified ETDRS design features with HOTV or Sloan optotypes (based on age), crowding bars, and displays 3 optotypes at a time (arranged vertically) to accommodate smaller screen sizes, but still significantly shortens testing time as opposed to displaying only a single optotype at a time.

The application may be used to screen children old enough to comprehend the test, typically around age 4 through adulthood, during their primary care, or school-based visits, and now, in the home. The purpose of home vision testing is to provide actionable insights into the status of an individual's vision without the need for an in-office visit. The testing results will be able to used by the physician to help determine if additional interventions are necessary.

The objective of this study is to determine if the results of the GoCheck visual acuity test performed in an office setting correlate to the same testing when implemented in the residence.

Conditions

Refractive Errors

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

GoCheck Kids (iOS)

Visual Acuity method is used to measure of the sharpness or clearness of vision.

Device: GoCheck Visual Acuity in Office (Windows) Photorefraction method is used to screen amblyopia risk factors.

Intervention Type: DEVICE

GoCheck Kids (Windows)

Visual Acuity method is used to measure of the sharpness or clearness of vision.

Intervention Type: DEVICE

GoCheck at Home (iOS)

Visual Acuity method is used to measure of the sharpness or clearness of vision.

Intervention Type: DEVICE

GoCheck at Home (Windows)

Visual Acuity method is used to measure of the sharpness or clearness of vision.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Ages four (4) to twenty(20) years, inclusive

2. Corrected visual acuity range of 20/16 to 20/100

3. Manifest or cycloplegic refraction within prior six (6) months

4. Ability to comprehend and complete the VA test with age appropriate optotypes

Exclusion Criteria

1. No access to smartphone

2. Inability to read, write, and/or understand English

3. Inability to provide written informed consent or have consent conferred on patient's behalf

4. Subjects from populations otherwise deemed ineligible/unable to provide informed consent and/or participate in studies (detention, correction, rehabilitation, psychiatric residents, etc.)

5. Current pregnancy

6. Any ocular pathology defect(s) except amblyopia, strabismus or refractive error or history of nystagmus.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gobiquity Mobile Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Huang, MD

Role: STUDY_CHAIR

Oregon Health and Science University

Locations

Alaska Children's Eye & Strabismus

Anchorage, Alaska, United States

Site Status: RECRUITING

Yale School of Medicine, Yale University

New Haven, Connecticut, United States

Site Status: NOT_YET_RECRUITING

Medical University of South Carolina-Storm Eye Institute

Charleston, South Carolina, United States

Site Status: NOT_YET_RECRUITING

Stern Hospital

Haifa, Tel Aviv, Israel

Site Status: RECRUITING

Countries

United States; Israel

Central Contacts

Lindsey Sangillo

Role: CONTACT

Lindsey.Sangillo@gocheckkids.com

18605140084

Facility Contacts

Robert Arnold, MD

Role: primary

Jill Rotruck, MD

Role: primary

Mae Peterseim, MD

Role: primary

Tamara Wygnanski-Jaffe, MD

Role: primary

Other Identifiers

2021-001

Identifier Type: -

Identifier Source: org_study_id