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
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia||Behavioral: Educational programme||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
- Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group
- Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance
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
|Frankfurt am Main, Germany, 60590|
|Leicester Royal Infirmary; Dept. of Ophthalmology|
|Leicester, United Kingdom, LE2 7LX|
|Study Chair:||Huibert J Simonsz, MD, PhD||ErasmusMC, Department of Ophthalmology|