AmblyopiaNCT05484453
Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders
An observational study of Amblyopia and Infant, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study. Read more about this study
- Who is it for?
- Ages 11 to 16 months
- What is being tested?
- Complete Eye Examination by Ophthalmologist
- How many people
- 460 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Aug 2021to May 2025
- 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 11 to 16 months
- All sexes
- Child
Study population: Children who undergo GCK evaluation at the Child And Family Agency consultation
Who may be able to join
- GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months.
Who cannot join
- Allergy for the used cycloplegia cyclopentolate 0.5%.
- Any history of ocular surgery
- The time window between GCK measurement and the complete eye examination may not exceed 2 months.
- The parents or legal representatives of the child do not understand or speak Dutch, French or English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.
The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.
Read the detailed description
Comparison of the results of the GoCheck Kids application on iPhone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.
- Being tested
- Complete Eye Examination by Ophthalmologist
- Keywords
- Eye screening
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Eye Examination by OphthalmologistDiagnostic test
complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.
| Study group | Role | What they receive |
|---|---|---|
| GoCheckKids screening | GoCheckKids screening at the Child And Family Agency at the age of 12-15 months (+- 1 month) are invited to undergo a complete eye examination by an ophthalmologist for evaluation of amblyopia risk factors. Receives: Diagnostic Test: Complete Eye Examination by Ophthalmologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of GCK eye screener
Measured: Day 1
Specificity
Specificity of GCK eye screener
Measured: Day 1
Positive predictive value
Positive predictive value of GCK eye screener
Measured: Day 1
Negative predictive value
Negative predictive value of GCK eye screener
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start4 Aug 2021
- Primary completion31 May 2022
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Cassiman, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484453
- Sponsor's protocol ID
- S64113
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Otto H, Deschoemaeker M, Van Overmeire B, Casteels I, Cassiman C. Validation of the eye screening tool GoCheck Kids for the detection of amblyopia risk factors in toddlers in Flanders. J AAPOS. 2024 Oct;28(5):104008. doi: 10.1016/j.jaapos.2024.104008. Epub 2024 Sep 19.
PubMed 39304027
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.
- ClinicalTrials.gov ID
- NCT05484453
- Acronym / sponsor ID
- S64113
- Keywords
- Eye screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 2 Aug 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.
The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.
Detailed description
Comparison of the results of the GoCheck Kids application on iPhone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GoCheckKids screening | – | Diagnostic Test: Complete Eye Examination by OphthalmologistGoCheckKids screening at the Child And Family Agency at the age of 12-15 months (+- 1 month) are invited to undergo a complete eye examination by an ophthalmologist for evaluation of amblyopia risk factors. |
Who may qualify
- Ages
- 11 to 16 months
- Sex
- All
- Age groups
- Child
- Study population
- Children who undergo GCK evaluation at the Child And Family Agency consultation
Key inclusion criteria (1 listed)
- GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months.
Key exclusion criteria (4 listed)
- Allergy for the used cycloplegia cyclopentolate 0.5%.
- Any history of ocular surgery
- The time window between GCK measurement and the complete eye examination may not exceed 2 months.
- The parents or legal representatives of the child do not understand or speak Dutch, French or English.
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 |
|---|---|---|
| Complete Eye Examination by Ophthalmologistcomplete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist. | Diagnostic test | GoCheckKids screening |
Primary outcome
Sensitivity
Time frame: Day 1
Sensitivity of GCK eye screener
Specificity
Time frame: Day 1
Specificity of GCK eye screener
Positive predictive value
Time frame: Day 1
Positive predictive value of GCK eye screener
Negative predictive value
Time frame: Day 1
Negative predictive value of GCK eye screener
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 39304027Otto H, Deschoemaeker M, Van Overmeire B, Casteels I, Cassiman C. Validation of the eye screening tool GoCheck Kids for the detection of amblyopia risk factors in toddlers in Flanders. J AAPOS. 2024 Oct;28(5):104008. doi: 10.1016/j.jaapos.2024.104008. Epub 2024 Sep 19.
- Individual participant dataSharing planned: No
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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.
Catherine Cassiman, MD, PhD principal investigator
UZ Leuven
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 and Infant, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 4 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 3 Jul 2024. 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 Belgium. 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?
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 (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05484453, which also lists 1 linked publication.
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 Jul 2024.