Comparison of Visual Acuity Performed in Office Versus In Residence

• Conditions: Refractive Errors

• Registration Number: NCT05250986
• Lead Sponsor: Gobiquity Mobile Health

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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study Start: 2022-02-14
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22
• Primary Completion: 2022-05-31
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 325

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of in-office visual acuity results to visual acuity results obtained in residence.	10 Days	correlation of visual acuity results obtained by trained personnel utilizing the GoCheck Kids Visual Acuity solution in an in-office clinical setting compared to the results obtained by individuals conducting the same visual acuity test in their residence.

Secondary Outcome Measures

Name	Time	Method
Accuracy of in residence visual acuity results to opthalmic visual acuity	10 Days	Accuracy of visual acuity results obtained in residence relative to standard ophthalmic visual acuity test.
Repeatability and Reproducibility of Visual Acuity in Residence	7 Days	The repeatability and reproducibility of results of visual acuity testing conducted in the residence within defined intervals

Trial Locations

Locations (4)

Yale School of Medicine, Yale University; 🇺🇸 New Haven, Connecticut, United States

Alaska Children's Eye & Strabismus; 🇺🇸 Anchorage, Alaska, United States

Medical University of South Carolina-Storm Eye Institute; 🇺🇸 Charleston, South Carolina, United States

Stern Hospital; 🇮🇱 Haifa, Tel Aviv, Israel