Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00131729
First received: August 18, 2005
Last updated: March 17, 2006
Last verified: March 2006
  Purpose

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 Intervention Phase
Amblyopia
Behavioral: Educational programme
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Further study details as provided by Erasmus Medical Center:

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

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

Estimated Enrollment: 200
Study Start Date: July 2001
Estimated Study Completion Date: December 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131729

Locations
Germany
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
Investigators
Study Chair: Huibert J Simonsz, MD, PhD ErasmusMC, Department of Ophthalmology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00131729     History of Changes
Other Study ID Numbers: 2300.0020
Study First Received: August 18, 2005
Last Updated: March 17, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
Amblyopia
Occlusion therapy
Compliance
Risk factors

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

ClinicalTrials.gov processed this record on April 22, 2014