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Clinical Trials/NCT00131729
NCT00131729CompletedPhase 3

Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance

Erasmus Medical Center4 sites in 2 countries200 target enrollmentStarted: July 2001Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
200
Locations
4
Primary Endpoint
Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single

Eligibility Criteria

Ages
0 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (4)

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