ClinicalTrials.gg
Status unknownNCT05250986VA IR vs IOUpdated Feb 22, 2022

Comparison of Visual Acuity Performed in Office Versus In Residence

An observational study in Refractive Errors, sponsored by Gobiquity Mobile Health. Status unknown at 4 sites in 2 countries. Open to participants aged 4 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-22.

Sponsored by Gobiquity Mobile Health · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
325
Ages
4 Years to 20 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 146 studies in Refractive Errors with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Refractive Errors · United States.

Planned enrollment
7th of 30
325 · median 121
Started
2022
with 12 others
Observational
30 of 146
2 open now
Registered
108th of 146
by date

Among the 146 studies in Refractive Errors with a site in United States, this one is the 7th largest by planned enrollment of the 30 observational ones, is one of 13 that started in 2022, is one of 30 observational ones, and was the 108th registered.

By phase

146 studies; the count open now beside each. This study's row is marked.

No phase98 · 1 open
Observationalthis study30 · 2 open
Phase 38 · 0 open
Phase 25 · 0 open
Phase 43 · 0 open
Phase 11 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1999; this study’s year is marked. 13 started in 2022.

Size and results

Median enrollment 68 across the 115 interventional studies, 121 across the 30 observational. Of the 126 that completed or were terminated, 79 (63%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 146 studies in Refractive Errors with a site in United States, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • Refractive Errors

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04

Who can participate

Ages eligible
4 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. No access to smartphone
  2. Inability to read, write, and/or understand English
  3. Inability to provide written 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
325 participants (estimated)
Patient registry
No

Interventions

  • DeviceGoCheck 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.

  • DeviceGoCheck Kids (Windows)

    Visual Acuity method is used to measure of the sharpness or clearness of vision.

  • DeviceGoCheck at Home (iOS)

    Visual Acuity method is used to measure of the sharpness or clearness of vision.

  • DeviceGoCheck at Home (Windows)

    Visual Acuity method is used to measure of the sharpness or clearness of vision.

06

What researchers measure

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.

    Time frame: 10 Days

Secondary outcomes

  1. 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.

    Time frame: 10 Days

  2. 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

    Time frame: 7 Days

07

Study locations

2 of 4 sites recruiting
  • Alaska Children's Eye & Strabismus
    Anchorage, Alaska 99508, United States
    Recruiting
    • Robert Arnold, MD · Contact
  • Yale School of Medicine, Yale University
    New Haven, Connecticut 06510, United States
    Not yet recruiting
    • Jill Rotruck, MD · Contact
  • Medical University of South Carolina-Storm Eye Institute
    Charleston, South Carolina 29425, United States
    Not yet recruiting
    • Mae Peterseim, MD · Contact
  • Stern Hospital
    Haifa, Tel Aviv, Israel
    Recruiting
    • Tamara Wygnanski-Jaffe, MD · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2022; primary completion for May 2022, 3 months later.

Of 42 observational studies under Refractive Errors, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2022
First posted
Feb 22, 2022
StartEst.
Feb 14, 2022
Primary completionEst.
May 31, 2022
CompletionEst.
Sep 1, 2022
Last update
Feb 22, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05250986
Lead sponsor
Gobiquity Mobile Health
Responsible party
Sponsor
First posted
Feb 22, 2022
Start date
Feb 14, 2022 (estimated)
Primary completion
May 31, 2022 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
Feb 22, 2022

Study contacts

Lindsey Sangillo
Contact
Lindsey.Sangillo@gocheckkids.com
18605140084
David Huang, MD
study chair · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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