Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
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|
- 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
|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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|