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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Albert von Metzler Foundation | OTHER |
| Augenstern Association, Germany | UNKNOWN |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational programme | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huibert J Simonsz, MD, PhD | ErasmusMC, Department of Ophthalmology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Augenklinik Frankfurt | Frankfurt am Main | 60590 | Germany | |||
| Leicester Royal Infirmary; Dept. of Ophthalmology |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| Edith von Heyden Foundation, Germany |
| UNKNOWN |
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| Leicester |
| LE2 7LX |
| United Kingdom |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |