Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

Phase 3

Completed

• Conditions: Amblyopia

• Registration Number: NCT00131729
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed 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 Timeline

• Study Start: 2001-07
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-08-18
• Study First Posted: 2005-08-19
• Study Completion: 2005-12
• Status Verified: 2006-03
• Last Update Submitted: 2006-03-17
• Last Update Posted: 2006-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All newly diagnosed amblyopic children with an inter-ocular difference in visual acuity of at least 0.2 logMAR, strabismus and/or anisometropia or deprivation (e.g. cataract)

Exclusion Criteria

• Previous treatment for amblyopia
• Neurological disorder
• Medication
• Other eye disorder
• Decreased visual acuity caused by brain damage or trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance

Trial Locations

Locations (2)

Universitäts-Augenklinik Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Leicester Royal Infirmary; Dept. of Ophthalmology; 🇬🇧 Leicester, United Kingdom