Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Amblyopia

Clinical Trial Details

NCT number	NCT00131729
Study type	Interventional
Source	Erasmus Medical Center
Contact
Status	Completed
Phase	Phase 3
Start date	July 2001
Completion date	December 2005

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