Comparison of Visual Acuity Performed in Office Versus In Residence (VA IR vs IO)

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

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors
• Intervention / Treatment: Device: GoCheck Kids (iOS); Device: GoCheck Kids (Windows); Device: GoCheck at Home (iOS); Device: GoCheck at Home (Windows)

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 Type: Observational
• Enrollment (Anticipated): 325

Contacts and Locations

• Study Contact: Name: Lindsey Sangillo; Phone Number: 18605140084; Email: Lindsey.Sangillo@gocheckkids.com

Study Locations

• Israel
  • Tel Aviv
    • Haifa, Tel Aviv, Israel
      • Recruiting
      • Stern Hospital
      • Contact: Tamara Wygnanski-Jaffe, MD
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Recruiting
      • Alaska Children's EYE & Strabismus
      • Contact: Robert Arnold, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Not yet recruiting
      • Yale School of Medicine, Yale University
      • Contact: Jill Rotruck, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Medical University of South Carolina-Storm Eye Institute
      • Contact: Mae Peterseim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

English-speaking individuals of any gender, aged four to twenty years, with recent refraction, able to comprehend and complete the visual acuity test with age appropriate optotypes.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Gobiquity Mobile Health
• Investigators: Study Chair: David Huang, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 14, 2022
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes