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临床试验/NCT00131729
NCT00131729已完成3 期

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

Erasmus Medical Center2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2001年7月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
200
试验地点
2
主要终点
Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •Previous treatment for amblyopia
  • •Neurological disorder
  • •Medication
  • •Other eye disorder
  • •Decreased visual acuity caused by brain damage or trauma

结局指标

主要结局

Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group

次要结局

  • Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance

研究者

申办方类型
Other

研究点 (2)

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