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Disinvestment Study of Population-Based Vision Screening in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Erasmus Medical Center
Sponsor:
Collaborators:
Icare Health Care, Dept. Youth Health Care, Meppel
Public Health Service of Amsterdam
Information provided by (Responsible Party):
Huib Simonsz, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01675193
First received: August 27, 2012
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Amblyopia
Behavioral: Omission of population-based child vision screening visits at 6-9 and 14-24 months

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Disinvestment Study of Population-Based Vision Screening in Preverbal Children in the Netherlands

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • The number of cases of amblyopia detected, weighted for visual acuity, against age at detection. [ Time Frame: 2011-2016 ] [ Designated as safety issue: No ]

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. [ Time Frame: 2011-2016 ] [ Designated as safety issue: No ]

Estimated Enrollment: 11770
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Current screening protocol
Eye screening at age 1-2, 3-4, 6-9, 14-24, 36, 45 and 54-60 months
Disinvestment protocol
No eye screening at 6-9 and 14-24 months
Behavioral: Omission of population-based child vision screening visits at 6-9 and 14-24 months

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.

  Eligibility

Ages Eligible for Study:   6 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675193

Contacts
Contact: Huibert J Simonsz, MD, PhD 0031651187878 simonsz@compuserve.com
Contact: Frea Sloot, MD 0031619825505 f.sloot@erasmusmc.nl

Locations
Netherlands
GGD Jeugdzorg Amsterdam Recruiting
Amsterdam, Netherlands
Contact: Trijntje Sjoerdsma         
Principal Investigator: Trijntje Sjoerdsma, C.O.         
Icare Jeugdgezondheidszorg Recruiting
Meppel, Netherlands
Contact: Janine Benjamins    0031522-279347    j.benjamins@icare.nl   
Principal Investigator: Janine ter Haar, MD         
Sponsors and Collaborators
Erasmus Medical Center
Icare Health Care, Dept. Youth Health Care, Meppel
Public Health Service of Amsterdam
Investigators
Study Chair: Huibert J Simonsz, MD, PhD ErasmusMC, Department of Ophthalmology
  More Information

No publications provided

Responsible Party: Huib Simonsz, Prof. H.J. Simonsz, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01675193     History of Changes
Other Study ID Numbers: ErasmusMC MEC-2012-003
Study First Received: August 27, 2012
Last Updated: August 14, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Erasmus Medical Center:
Amblyopia
Vision-Screening

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on November 25, 2014