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Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131729
First Posted: August 19, 2005
Last Update Posted: March 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Albert von Metzler Foundation
Augenstern Association, Germany
Edith von Heyden Foundation, Germany
Information provided by:
Erasmus Medical Center
August 18, 2005
August 19, 2005
March 20, 2006
July 2001
Not Provided
Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group
Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group.
Complete list of historical versions of study NCT00131729 on ClinicalTrials.gov Archive Site
Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance
Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.
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Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance
The purpose of this study was to determine whether compliance with occlusion therapy for amblyopia could be improved and, secondly, if risk factors for non-compliance could be identified.

Non-compliance is a limiting factor for success of occlusion therapy for amblyopia (lazy eye) in childhood. It is responsible for approximately 1% of the adult population being unable to read with the amblyopic eye. The researchers used electronic monitoring of compliance to investigate predictors and a remedy for non-compliance.

Methods: In a prospective randomised controlled trial, compliance was measured for one week every three months during 30 months in newly diagnosed amblyopic children in The Hague, Frankfurt and Leicester. The family’s social-economic and ethnic background was assessed through a questionnaire. Children were randomised to receive either an educational cartoon story explaining, without text, the rationale for treatment to the child with reward stickers and an information sheet, or a picture to colour. All received standard orthoptic care by a treating orthoptist, who was unaware of the randomisation. The electronic device and educational programme were distributed via home-visits by researchers. The primary outcome measure was percentage of compliance (realised/prescribed occlusion time). The secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Amblyopia
Behavioral: Educational programme
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2005
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Inclusion Criteria:

  • All newly diagnosed amblyopic children with an inter-ocular difference in visual acuity of at least 0.2 logMAR, strabismus and/or anisometropia or deprivation (e.g. cataract)

Exclusion Criteria:

  • Previous treatment for amblyopia
  • Neurological disorder
  • Medication
  • Other eye disorder
  • Decreased visual acuity caused by brain damage or trauma
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
 
NCT00131729
2300.0020
Not Provided
Not Provided
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Erasmus Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Albert von Metzler Foundation
  • Augenstern Association, Germany
  • Edith von Heyden Foundation, Germany
Study Chair: Huibert J Simonsz, MD, PhD ErasmusMC, Department of Ophthalmology
Erasmus Medical Center
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP