Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group []
Secondary Outcome Measures
- Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance []
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitäts-Augenklinik Frankfurt | Frankfurt am Main | Germany | 60590 | |
| 2 | Leicester Royal Infirmary; Dept. of Ophthalmology | Leicester | United Kingdom | LE2 7LX |
Sponsors and Collaborators
- Erasmus Medical Center
- ZonMw: The Netherlands Organisation for Health Research and Development
- Albert von Metzler Foundation
- Augenstern Association, Germany
- Edith von Heyden Foundation, Germany
Investigators
- Study Chair: Huibert J Simonsz, MD, PhD, ErasmusMC, Department of Ophthalmology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2300.0020