Clinical trial NCT00131729: Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
Official title: Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amblyopia
Keywords: Amblyopia
Occlusion therapy
Compliance
Risk factors
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Albert von Metzler Foundation
name: Augenstern Association, Germany
name: Edith von Heyden Foundation, Germany
First posted: 2005-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group
Secondary outcomes:
measure: Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Universitäts-Augenklinik Frankfurt
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept. of Ophthalmology
Study officials:
affiliation: ErasmusMC, Department of Ophthalmology
name: Huibert J Simonsz, MD, PhD
role: STUDY_CHAIR
References: