Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
Primary Purpose
Amblyopia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Educational programme
Sponsored by
About this trial
This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, Occlusion therapy, Compliance, Risk factors
Eligibility 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
Sites / Locations
- Universitäts-Augenklinik Frankfurt
- Leicester Royal Infirmary; Dept. of Ophthalmology
Outcomes
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
Full Information
NCT ID
NCT00131729
First Posted
August 18, 2005
Last Updated
March 17, 2006
Sponsor
Erasmus Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Albert von Metzler Foundation, Augenstern Association, Germany, Edith von Heyden Foundation, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00131729
Brief Title
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
Official Title
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Erasmus Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Albert von Metzler Foundation, Augenstern Association, Germany, Edith von Heyden Foundation, Germany
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Amblyopia, Occlusion therapy, Compliance, Risk factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Educational programme
Primary Outcome Measure Information:
Title
Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group
Secondary Outcome Measure Information:
Title
Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huibert J Simonsz, MD, PhD
Organizational Affiliation
ErasmusMC, Department of Ophthalmology
Official's Role
Study Chair
Facility Information:
Facility Name
Universitäts-Augenklinik Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Leicester Royal Infirmary; Dept. of Ophthalmology
City
Leicester
ZIP/Postal Code
LE2 7LX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
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