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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05484453
• Collaborator: (none)
• Enrollment: 460
• Location: 1
• Anticipated Duration (Months): 20.9
• Patients Per Site Per Month: 22

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Amblyopia; Infant	Diagnostic Test: Complete Eye Examination by Ophthalmologist

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

• Study Type: Observational
• Anticipated Enrollment: 460 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.
• Actual Study Start Date: Aug 4, 2021
• Actual Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: Complete Eye Examination by Ophthalmologist; complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Outcome Measures

Primary Outcome Measures

1. Sensitivity [Day 1]

   Sensitivity of GCK eye screener

2. Specificity [Day 1]

   Specificity of GCK eye screener

3. Positive predictive value [Day 1]

   Positive predictive value of GCK eye screener

4. Negative predictive value [Day 1]

   Negative predictive value of GCK eye screener

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Months to 16 Months
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: Catherine Cassiman, MD, PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT05484453
• Other Study ID Numbers: S64113
• First Posted: Aug 2, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitaire Ziekenhuizen Leuven: Eye screening
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Aug 10, 2022