Comparison of Visual Acuity Performed in Office Versus In Residence
VA IR vs IO
1 other identifier
observational
325
2 countries
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedStudy Start
First participant enrolled
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedFebruary 22, 2022
February 1, 2022
4 months
February 11, 2022
February 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Accuracy of in residence visual acuity results to opthalmic visual acuity
10 Days
Repeatability and Reproducibility of Visual Acuity in Residence
7 Days
Interventions
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.
Visual Acuity method is used to measure of the sharpness or clearness of vision.
Visual Acuity method is used to measure of the sharpness or clearness of vision.
Visual Acuity method is used to measure of the sharpness or clearness of vision.
Eligibility Criteria
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.
You may qualify if:
- Ages four (4) to twenty(20) years, inclusive
- Corrected visual acuity range of 20/16 to 20/100
- Manifest or cycloplegic refraction within prior six (6) months
- Ability to comprehend and complete the VA test with age appropriate optotypes
You may not qualify if:
- No access to smartphone
- Inability to read, write, and/or understand English
- Inability to provide written informed consent or have consent conferred on patient's behalf
- Subjects from populations otherwise deemed ineligible/unable to provide informed consent and/or participate in studies (detention, correction, rehabilitation, psychiatric residents, etc.)
- Current pregnancy
- Any ocular pathology defect(s) except amblyopia, strabismus or refractive error or history of nystagmus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Alaska Children's Eye & Strabismus
Anchorage, Alaska, 99508, United States
Yale School of Medicine, Yale University
New Haven, Connecticut, 06510, United States
Medical University of South Carolina-Storm Eye Institute
Charleston, South Carolina, 29425, United States
Stern Hospital
Haifa, Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Huang, MD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 22, 2022
Study Start
February 14, 2022
Primary Completion
May 31, 2022
Study Completion
September 1, 2022
Last Updated
February 22, 2022
Record last verified: 2022-02