AmblyopiaNCT03447171
Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
An observational study of Amblyopia, run by Gobiquity Mobile Health at 1 site in United States.
Trial summary
The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs). Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- App Vision Screening
- Type of treatment
- Medical device
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 4 Jun 2018
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Study population will be selected from eye clinics.
Who may be able to join
- Age 12 months to 8 years inclusive.
- Informed consent given by parent or legal guardian.
Who cannot join
- History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Children's Eye & Strabismus
Anchorage, Alaska, 99508
About this study
The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs).
Read the detailed description
Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years
- Conditions
- Amblyopia
- Being tested
- App Vision Screening
- Keywords
- Amblyopia, Myopia, Hyperopia, Risk Factors, Amblyopia Risk Factors, Smartphone Application (App), Photoscreening, Vision Screening, Mobile Vision Screening, Vision Screening App, Preschool children, Objective vision screening
- Medical subject headings
- Amblyopia, Myopia, Hyperopia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App Vision ScreeningDevice
Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors
| Study group | Role | What they receive |
|---|---|---|
| Refractive Error | Not described Receives: Device: App Vision Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of amblyopia risk factors detected by Photorefraction
Identification of risk factors compared to gold standard cycloplegic refraction
Measured: 1 day
Secondary outcomes (1)
Number of patients with gaze error identified by photo screening
Detection of gaze error compared to cover test examination results
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start7 Feb 2018
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gobiquity Mobile Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Donahue, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447171
- Sponsor's protocol ID
- 2018-001
- Status last verified
- Aug 2018
- First submitted
- 21 Feb 2018
- Last updated
- 3 Aug 2018
- 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 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
- ClinicalTrials.gov ID
- NCT03447171
- Acronym / sponsor ID
- 2018-001
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Myopia, Hyperopia, Risk Factors, Amblyopia Risk Factors, Smartphone Application (App), Photoscreening, Vision Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Gobiquity Mobile HealthIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 27 Feb 2018 (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.
The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs).
Detailed description
Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractive Error | – | Device: App Vision Screening |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study population will be selected from eye clinics.
Key inclusion criteria (2 listed)
- Age 12 months to 8 years inclusive.
- Informed consent given by parent or legal guardian.
Key exclusion criteria (1 listed)
- History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement
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 |
|---|---|---|
| App Vision ScreeningUsing GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors | Device | Refractive Error |
Primary outcome
Sensitivity and specificity of amblyopia risk factors detected by Photorefraction
Time frame: 1 day
Identification of risk factors compared to gold standard cycloplegic refraction
1 secondary outcome
Number of patients with gaze error identified by photo screening
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Amblyopia
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
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.
Sean Donahue, MD, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia, run by Gobiquity Mobile Health at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of amblyopia risk factors detected by Photorefraction (time frame: 1 day). 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 3 Aug 2018.