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Disinvestment Study of Population-Based Vision Screening in Children

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Disinvestment protocol
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Amblyopia focused on measuring Amblyopia, Vision-Screening

Eligibility Criteria

6 Months - 14 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All children visiting the selected screening offices and becoming 6 months of age(in a 6 months period from the start of recruiting).

Exclusion Criteria:

  • previous eye surgery
  • previous eye disorder

Sites / Locations

  • GGD Jeugdzorg Amsterdam
  • Icare Jeugdgezondheidszorg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Current screening protocol

Disinvestment protocol

Arm Description

Eye screening at age 1-2, 3-4, 6-9, 14-24, 36, 45 and 54-60 months

No eye screening at 6-9 and 14-24 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 27, 2012
Last Updated
August 18, 2017
Sponsor
Erasmus Medical Center
Collaborators
Public Health Service of Amsterdam, Icare Youth Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT01675193
Brief Title
Disinvestment Study of Population-Based Vision Screening in Children
Official Title
Disinvestment Study of Population-Based Vision Screening in Preverbal Children in the Netherlands
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Public Health Service of Amsterdam, Icare Youth Health Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Amblyopia (prevalence 3 - 4%)is a preventable, unilateral loss of vision in young children, in most cases caused by strabismus (squint) or unilateral hypermetropia (need of plus glasses), or both. The sensitive period in which vision loss can develop and be recovered, by covering the better eye with a patch, is up to 6 years of age. Population-based programs for child vision screening exist in Sweden, the United Kingdom, Canada, eastern European countries and the Netherlands. Measurement of visual acuity at age four (preschool) is most common. In some countries, including Canada and the Netherlands, preverbal screening of visual function in infants and young children (age 0 - 2) has been added to the screening program. In the Netherlands, it is applied during the regular visits at ages 1-2, 3-4, 6-9, 14-24 months. At the age of 36 months, monocular visual acuity is tested with a picture chart. At the age of 45 and 60 months, monocular visual acuity is measured with the Landolt-C chart. In 1996, the investigators started a follow-up study of a birth cohort in Rotterdam (RAMSES) to determine the sensitivity, specificity and effectiveness of the screening program. A diagnosis of amblyopia was made in 100 (3.4%) of 2,964 children and was caused by refractive error (42), strabismus (19), both combined (30) or deprivation (7). It was found that most cases of amblyopia were detected by vision screening with measurement of visual acuity from age 3 years onwards. Preverbal screening enabled earlier detection of strabismus amblyopia, but not at all of refractive amblyopia. The investigators therefore propose a disinvestment study of vision screening, with omission of screening at age 6-9 and 14-24 months. First, the optimal screening intervals are calculated with a newly developed micro-simulation model for effectiveness of repeated screening, on the basis of the data obtained in the RAMSES study. The model simulation predicted that screening at age 6-9 and 14-24 months can be omitted without an appreciable loss of number of detected amblyopia cases. This will be tested in a RCT among two large youth health care organisations, ICARE (12,500 new children annually) and GGD-Amsterdam. Two large birth-cohorts will be recruited. Children born between July and December 2011 will form our control group and will be examined at 6-9, 14-24, 36 and 45 months. Children born between January and June 2012 will be our intervention group. These children will be examined only at 36 and 45 months. Endpoint is the number of cases of amblyopia detected, weighted for visual acuity, against age at detection. The question is whether a significant difference between groups can be found in the cumulative number of cases of amblyopia detected up to the age of 4 years. The new model for optimising screening intervals will be developed further in the course of the study into a generic tool for determining optimal screening intervals in any screening program with repeated exams for young children and should ultimately allow for comparison of effectiveness of population-based screening programs for different disorders in different countries, carried out by different personnel. Finally, in the RAMSES study 23% of the children screened positively had not been referred successfully to an ophthalmologist or orthoptist; 43% of their parents had low to moderate fluency in the Dutch language. This reflects lack of utilisation among immigrants of preventive screening and a faltering transit from prevention to care. Unsuccessful referral, in relation to parental fluency in Dutch, ethnicity and SES will, hence, be monitored in the study in an exploratory fashion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Amblyopia, Vision-Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10803 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current screening protocol
Arm Type
No Intervention
Arm Description
Eye screening at age 1-2, 3-4, 6-9, 14-24, 36, 45 and 54-60 months
Arm Title
Disinvestment protocol
Arm Type
Other
Arm Description
No eye screening at 6-9 and 14-24 months
Intervention Type
Behavioral
Intervention Name(s)
Disinvestment protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.
Description
The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.
Time Frame
2011-2016
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2011-2016

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All children visiting the selected screening offices and becoming 6 months of age(in a 6 months period from the start of recruiting). Exclusion Criteria: previous eye surgery previous eye disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huibert J Simonsz, MD, PhD
Organizational Affiliation
ErasmusMC, Department of Ophthalmology
Official's Role
Study Chair
Facility Information:
Facility Name
GGD Jeugdzorg Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Icare Jeugdgezondheidszorg
City
Meppel
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25270899
Citation
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.
Results Reference
derived

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Disinvestment Study of Population-Based Vision Screening in Children

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