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

Universitaire Ziekenhuizen KU Leuven

Status: Active, not recruiting

Conditions: Amblyopia; Infant

Treatments: Diagnostic Test: Complete Eye Examination by Ophthalmologist

Study type: Observational

Funder types: Other

Identifiers

NCT05484453

S64113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 estimated patients

Sex: All

Ages: 11 to 16 months old

Volunteers: No Healthy Volunteers

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.

Trial design

460 participants in 1 patient group

GoCheckKids screening

Description:

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.

Treatment:

Diagnostic Test: Complete Eye Examination by Ophthalmologist