Comparison of Visual Acuity Performed in Office Versus In Residence

Refractive Errors Clinical Trial

— VA IR vs IO  

Official title:

Comparison of Visual Acuity Performed in Office Versus In Residence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250986
• Other study ID #: 2021-001
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2022
• Source: Gobiquity Mobile Health
• Contact: Lindsey Sangillo
• Phone: 18605140084
• Email: Lindsey.Sangillo[@]gocheckkids.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: September 1, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• 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.
• GoCheck Kids (Windows)
Visual Acuity method is used to measure of the sharpness or clearness of vision.
• GoCheck at Home (iOS)
Visual Acuity method is used to measure of the sharpness or clearness of vision.
• GoCheck at Home (Windows)
Visual Acuity method is used to measure of the sharpness or clearness of vision.

Locations

Country	Name	City	State
Israel	Stern Hospital	Haifa	Tel Aviv
United States	Alaska Children's Eye & Strabismus	Anchorage	Alaska
United States	Medical University of South Carolina-Storm Eye Institute	Charleston	South Carolina
United States	Yale School of Medicine, Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Gobiquity Mobile Health

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of in-office visual acuity results to visual acuity results obtained in residence.	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.	10 Days
Secondary	Accuracy of in residence visual acuity results to opthalmic visual acuity	Accuracy of visual acuity results obtained in residence relative to standard ophthalmic visual acuity test.	10 Days
Secondary	Repeatability and Reproducibility of Visual Acuity in Residence	The repeatability and reproducibility of results of visual acuity testing conducted in the residence within defined intervals	7 Days