Disinvestment Study of Population-Based Vision Screening in Children
1 other identifier
interventional
10,803
1 country
2
Brief Summary
The purpose of this study is to determine the optimal screening intervals and cost-effectiveness of population-based vision screening in preverbal children in the Netherlands.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedAugust 22, 2017
August 1, 2017
5.2 years
August 27, 2012
August 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.
The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.
2011-2016
Secondary Outcomes (1)
Cost-effectiveness analysis of vision screening in the two regions under both scenarios, with and without screening at age 6-9 and 14-24 months.
2011-2016
Study Arms (2)
Current screening protocol
NO INTERVENTIONEye screening at age 1-2, 3-4, 6-9, 14-24, 36, 45 and 54-60 months
Disinvestment protocol
OTHERNo eye screening at 6-9 and 14-24 months
Interventions
Omission of population-based child vision screening visits at 6-9 and 14-24 months: Children in the intervention group will not be eye screened at age 6-24 months
Eligibility Criteria
You may qualify if:
- All children visiting the selected screening offices and becoming 6 months of age(in a 6 months period from the start of recruiting).
You may not qualify if:
- previous eye surgery
- previous eye disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Public Health Service of Amsterdamcollaborator
- Icare Youth Health Carecollaborator
Study Sites (2)
GGD Jeugdzorg Amsterdam
Amsterdam, Netherlands
Icare Jeugdgezondheidszorg
Meppel, Netherlands
Related Publications (1)
Sloot F, Sami A, Karaman H, Benjamins J, Loudon SE, Raat H, Sjoerdsma T, Simonsz HJ. Effect of omission of population-based eye screening at age 6-9 months in the Netherlands. Acta Ophthalmol. 2015 Jun;93(4):318-21. doi: 10.1111/aos.12556. Epub 2014 Oct 1.
PMID: 25270899DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huibert J Simonsz, MD, PhD
ErasmusMC, Department of Ophthalmology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. H.J. Simonsz, MD, PhD
Study Record Dates
First Submitted
August 27, 2012
First Posted
August 29, 2012
Study Start
February 1, 2012
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08