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

Resource links provided by NLM:


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
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: 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 July 22, 2014