Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

Erasmus University

Status and phase

Completed

Phase 3

Conditions

Amblyopia

Treatments

Behavioral: Educational programme

Study type

Interventional

Funder types

Other

Identifiers

NCT00131729

2300.0020

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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