NCT05250986

Comparison of Visual Acuity Performed in Office Versus In Residence

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 325 (estimated)
• Sponsor: Gobiquity Mobile Health · Industry
• Sex: All
• Age: 4 Years – 20 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
DEVICE	GoCheck Kids (Windows)	Visual Acuity method is used to measure of the sharpness or clearness of vision.
DEVICE	GoCheck at Home (iOS)	Visual Acuity method is used to measure of the sharpness or clearness of vision.
DEVICE	GoCheck at Home (Windows)	Visual Acuity method is used to measure of the sharpness or clearness of vision.

Timeline

• Start date: 2022-02-14
• Primary completion: 2022-05-31
• Completion: 2022-09-01
• First posted: 2022-02-22
• Last updated: 2022-02-22

Locations

4 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study