Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders

NCT ID: NCT05484453

Last Updated: 2024-07-03

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-04

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Amblyopia Infant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months.

Exclusion Criteria

* 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.
Minimum Eligible Age

11 Months

Maximum Eligible Age

16 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Cassiman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S64113

Identifier Type: -

Identifier Source: org_study_id

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