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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Universitäts-Augenklinik Frankfurt
Frankfurt am Main, Germany
Leicester Royal Infirmary; Dept. of Ophthalmology
Leicester, United Kingdom
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
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