Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131729
Status:
COMPLETED
Last Update Posted:
2006-03-20
First Post:
2005-08-18
Brief Title:
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia 1 Effects of Patient Education on Compliance 2 Predictors for Non-Compliance
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 familys 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 realisedprescribed occlusion time The secondary outcome measure was influence of social-economic ethnic and clinical factors on 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 familys 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 realisedprescribed occlusion time The secondary outcome measure was influence of social-economic ethnic and clinical factors on compliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None