Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

Amblyopia Clinical Trial

Official title:

Electronic Recording of Compliance With Occlusion Therapy for Amblyopia: 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131729
• Other study ID #: 2300.0020
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2005
• Last updated: March 17, 2006
• Start date: July 2001
• Est. completion date: December 2005

Study information

• Verified date: March 2006
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia

Intervention

Behavioral:
• Educational programme

Locations

Country	Name	City	State
Germany	Universitäts-Augenklinik Frankfurt	Frankfurt am Main
United Kingdom	Leicester Royal Infirmary; Dept. of Ophthalmology	Leicester

Sponsors (5)

Lead Sponsor	Collaborator
Erasmus Medical Center	Albert von Metzler Foundation, Augenstern Association, Germany, Edith von Heyden Foundation, Germany, ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group
Secondary	Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance