Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders
NCT ID: NCT05484453
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
460 participants
OBSERVATIONAL
2021-08-04
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Complete Eye Examination by Ophthalmologist
complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.
Interventions
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Complete Eye Examination by Ophthalmologist
complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
11 Months
16 Months
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Catherine Cassiman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S64113
Identifier Type: -
Identifier Source: org_study_id
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