Clinical trial NCT05250986: Comparison of Visual Acuity Performed in Office Versus In Residence
Official title: Comparison of Visual Acuity Performed in Office Versus In Residence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractive Errors
Lead sponsor: Gobiquity Mobile Health
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 325
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of in-office visual acuity results to visual acuity results obtained in residence.
timeFrame: 10 Days
Secondary outcomes:
measure: Accuracy of in residence visual acuity results to opthalmic visual acuity
timeFrame: 10 Days
measure: Repeatability and Reproducibility of Visual Acuity in Residence
timeFrame: 7 Days
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Children's Eye & Strabismus
state: Alaska
city: New Haven
country: United States
facility: Yale School of Medicine, Yale University
state: Connecticut
city: Charleston
country: United States
facility: Medical University of South Carolina-Storm Eye Institute
state: South Carolina
city: Haifa
country: Israel
facility: Stern Hospital
state: Tel Aviv
Study officials:
affiliation: Oregon Health and Science University
name: David Huang, MD
role: STUDY_CHAIR
References: