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Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131729
Enrollment
200
Registered
2005-08-19
Start date
2001-07-31
Completion date
2005-12-31
Last updated
2006-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Keywords

Amblyopia, Occlusion therapy, Compliance, Risk factors

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.

Interventions

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Albert von Metzler Foundation
CollaboratorOTHER
Augenstern Association, Germany
CollaboratorUNKNOWN
Edith von Heyden Foundation, Germany
CollaboratorUNKNOWN
Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
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

Design outcomes

Primary

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

Secondary

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

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026