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Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

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ClinicalTrials.gov Identifier: NCT00131729
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : March 20, 2006
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amblyopia Behavioral: Educational programme Phase 3

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance
Study Start Date : July 2001
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group

Secondary Outcome Measures :
  1. Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131729

Universitäts-Augenklinik Frankfurt
Frankfurt am Main, Germany, 60590
United Kingdom
Leicester Royal Infirmary; Dept. of Ophthalmology
Leicester, United Kingdom, LE2 7LX
Sponsors and Collaborators
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
More Information

ClinicalTrials.gov Identifier: NCT00131729     History of Changes
Other Study ID Numbers: 2300.0020
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: March 20, 2006
Last Verified: March 2006

Keywords provided by Erasmus Medical Center:
Occlusion therapy
Risk factors

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