Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Erasmus Medical Center The Netherlands Organization 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 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance |
Estimated Enrollment: | 200 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | December 2005 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Universitäts-Augenklinik Frankfurt | |
Frankfurt am Main, Germany, 60590 | |
United Kingdom | |
Leicester Royal Infirmary; Dept. of Ophthalmology | |
Leicester, United Kingdom, LE2 7LX |
Study Chair: | Huibert J Simonsz, MD, PhD | ErasmusMC, Department of Ophthalmology |
Study ID Numbers: | 2300.0020 |
Study First Received: | August 18, 2005 |
Last Updated: | March 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00131729 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Amblyopia Occlusion therapy Compliance Risk factors |
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia |
Eye Diseases Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Nervous System Diseases |