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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Notify MeKey information
Conditions
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
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
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
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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