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Completed

NCT Number: NCT00131729

Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

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.

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Key information

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitäts-Augenklinik Frankfurt, Frankfurt am Main, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational programme

Behavioral

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Albert von Metzler Foundation
  • Augenstern Association, Germany
  • Edith von Heyden Foundation, Germany
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2005
First posted
Aug 19, 2005
Registry last updated
Mar 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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