Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Educational programme

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Huibert J Simonsz, MD, PhD

Role: STUDY_CHAIR

ErasmusMC, Department of Ophthalmology

Locations

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Universitäts-Augenklinik Frankfurt

Frankfurt am Main, , Germany

Site Status

Leicester Royal Infirmary; Dept. of Ophthalmology

Leicester, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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2300.0020

Identifier Type: -

Identifier Source: org_study_id