Refractive ErrorsVA IR vs IONCT05250986
Comparison of Visual Acuity Performed in Office Versus In Residence
An observational study of Refractive Errors, run by Gobiquity Mobile Health at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- GoCheck Kids (iOS), GoCheck Kids (Windows) and GoCheck at Home (iOS)
- Type of treatment
- Medical device
- How many people
- 325 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Feb 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Alaska Children's Eye & Strabismus
Anchorage, Alaska, 99508
Robert Arnold, MD
- Not yet recruiting
Medical University of South Carolina-Storm Eye Institute
Charleston, South Carolina, 29425
Mae Peterseim, MD
- Not yet recruiting
Yale School of Medicine, Yale University
New Haven, Connecticut, 06510
Jill Rotruck, MD
Israel1 site, 1 recruiting
- Recruiting
Stern Hospital
Haifa, Tel Aviv
Tamara Wygnanski-Jaffe, MD
About this study
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.
- Conditions
- Refractive Errors
- Being tested
- GoCheck Kids (iOS), GoCheck Kids (Windows), GoCheck at Home (iOS), GoCheck at Home (Windows)
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoCheck Kids (iOS)Device
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.
GoCheck Kids (Windows)Device
Visual Acuity method is used to measure of the sharpness or clearness of vision.
GoCheck at Home (iOS)Device
Visual Acuity method is used to measure of the sharpness or clearness of vision.
GoCheck at Home (Windows)Device
Visual Acuity method is used to measure of the sharpness or clearness of vision.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 Days
Secondary outcomes (2)
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.
Measured: 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
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start14 Feb 2022 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gobiquity Mobile Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Huang, MD, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250986
- Sponsor's protocol ID
- 2021-001
- Acronym
- VA IR vs IO
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Acuity Performed in Office Versus In Residence
- ClinicalTrials.gov ID
- NCT05250986
- Acronym / sponsor ID
- VA IR vs IO / 2021-001
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Gobiquity Mobile HealthIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Correlation of in-office visual acuity results to visual acuity results obtained in residence.
Time frame: 10 Days
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.
2 secondary outcomes
Accuracy of in residence visual acuity results to opthalmic visual acuity
Time frame: 10 Days
Repeatability and Reproducibility of Visual Acuity in Residence
Time frame: 7 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Huang, MD study chair
Oregon Health and Science University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Gobiquity Mobile Health at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Sangillo (18605140084, Lindsey.Sangillo@gocheckkids.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of in-office visual acuity results to visual acuity results obtained in residence. (time frame: 10 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.