AmblyopiaNCT03119675
Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
A study testing GoCheck Kids (iOS) and GoCheck Kids (Windows) in people with Amblyopia, run by Gobiquity Mobile Health.
Trial summary
Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs) Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™ App and patients are evaluated with cycloplegic… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- GoCheck Kids (iOS) and GoCheck Kids (Windows)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2017
- Phase
- Interventional
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12 months to 6 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
About this study
Official title: Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)
Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™ App and patients are evaluated with cycloplegic refraction.
- Conditions
- Amblyopia
- Being tested
- GoCheck Kids (iOS), GoCheck Kids (Windows)
- Keywords
- Myopia, Hyperopia, Anisometropia, Amblyopia Risk Factors, Risk Factors, Smartphone Application (App), Photoscreening, Vision Screening, Mobile Vision Screening
- Medical subject headings
- Amblyopia, Myopia, Hyperopia, Anisometropia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoCheck Kids (iOS)Device
Photorefraction method is used to screen amblyopia risk factors.
GoCheck Kids (Windows)Device
Photorefraction method is used to screen amblyopia risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Photorefraction of ages 1 to 6 years | Other | Clinical Validation of GoCheck Kids Smartphone App Receives: Device: GoCheck Kids (iOS); Device: GoCheck Kids (Windows) |
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 photo refraction
Identification of risk factors as 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 posted18 Apr 2017
- Study startNov 2016
- Primary completionMar 2017
- Study completionMay 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 358 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
- NCT03119675
- Sponsor's protocol ID
- 2016-001
- Status last verified
- Mar 2018
- First submitted
- 11 Apr 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
- ClinicalTrials.gov ID
- NCT03119675
- Acronym / sponsor ID
- 2016-001
- Conditions
- Amblyopia
- Keywords
- Myopia, Hyperopia, Anisometropia, Amblyopia Risk Factors, Risk Factors, Smartphone Application (App), Photoscreening, Vision Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Gobiquity Mobile HealthIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Apr 2017 (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.
Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)
Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™ App and patients are evaluated with cycloplegic refraction.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photorefraction of ages 1 to 6 years | Other | Device: GoCheck Kids (iOS), Device: GoCheck Kids (Windows)Clinical Validation of GoCheck Kids Smartphone App |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 12 months to 6 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 |
|---|---|---|
| GoCheck Kids (iOS)Photorefraction method is used to screen amblyopia risk factors. | Device | Photorefraction of ages 1 to 6 years |
| GoCheck Kids (Windows)Photorefraction method is used to screen amblyopia risk factors. | Device | Photorefraction of ages 1 to 6 years |
Primary outcome
Sensitivity and specificity of amblyopia risk factors detected by photo refraction
Time frame: 1 Day
Identification of risk factors as 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 13 Mar 2018.
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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.
Sean Donahue, MD, PhD principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing GoCheck Kids (iOS) and GoCheck Kids (Windows) in people with Amblyopia, run by Gobiquity Mobile Health.
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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 photo refraction (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 13 Mar 2018.