Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Amblyopia |
Behavioral: Educational programme |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance |
- Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group
- Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | December 2005 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Germany | |
| Universitäts-Augenklinik Frankfurt | |
| Frankfurt am Main, Germany, 60590 | |
| United Kingdom | |
| Leicester Royal Infirmary; Dept. of Ophthalmology | |
| Leicester, United Kingdom, LE2 7LX | |
| Study Chair: | Huibert J Simonsz, MD, PhD | ErasmusMC, Department of Ophthalmology |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00131729 History of Changes |
| Other Study ID Numbers: | 2300.0020 |
| Study First Received: | August 18, 2005 |
| Last Updated: | March 17, 2006 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Erasmus Medical Center:
|
Amblyopia Occlusion therapy Compliance Risk factors |
Additional relevant MeSH terms:
|
Amblyopia Brain Diseases Central Nervous System Diseases Nervous System Diseases Vision Disorders |
Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013