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临床试验/NCT03767985
NCT03767985Unknown不适用

A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2017年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
124
试验地点
1
主要终点
Visual Acuity improvement

研究概览

简要总结

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.

详细描述

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%.

In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.

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 (Care Provider)

盲法说明

The research orthoptist that does the orthoptic examinations is masked to the randomization.

入排标准

年龄范围
4 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.

排除标准

  • •A non-comitant or large angle constant strabismus >30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.

研究组 & 干预措施

Occlusion therapy

Active Comparator

Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.

干预措施: Occlusion therapy (Other)

Dichoptic video game therapy

Experimental

Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.

干预措施: Dichoptic video game therapy (Other)

结局指标

主要结局

Visual Acuity improvement

时间窗: 24 weeks

Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sjoukje Elizabeth Loudon

MD, PhD

Erasmus Medical Center

研究点 (1)

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