Evaluation and Development of a Novel Binocular Treatment (I-BiTTM) System Using Video Clips and Interactive Games to Improve Vision in Children With Amblyopia ('Lazy Eye').
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change from baseline in visual acuity
研究概览
简要总结
The study aims to determine whether 30 minutes of treatment playing an interactive computer game weekly for 6 weeks, improves visual acuity. The game has been specially configured to ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses which manipulate the image seen by each eye in order to provide more information to the amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM technology, play the computer game but without the I-BiTTM technology, or watch a DVD using the I-BiTTM technology.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Anisometropic, Strabismic or Mixed Amblyopia as made by an Orthoptist
- •Male or Female
- •Aged 4 - 8 years inclusive.
- •Participant's parent or guardian is willing and able to give informed consent for participation in the study
排除标准
- •Stimulus deprivation amblyopia.
- •Organic lesions of the eye preventing the establishment of good vision (e.g. media opacities, abnormalities in the fundus or optic nerve).
- •Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment).
- •Patients diagnosed with Photosensitive Epilepsy
- •Patients diagnosed with or suspected of having Conjunctivitis
- •Loss of suppression at filter 4 or less as measured with the Sbisa Bar
- •Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
- •Inability to comply with the follow up visits required
- •Refusal to accept randomisation
- •Have participated in a previous study examining I-BiT treatment
研究组 & 干预措施
I-BiTTM game
30 minutes intervention weekly for 6 weeks.
干预措施: I-BiTTM game (Device)
Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
干预措施: Non-I-BiTTM game (Device)
I-BiTTM DVD
30 minutes intervention weekly for 6 weeks.
干预措施: I-BiTTM DVD (Device)
结局指标
主要结局
Change from baseline in visual acuity
时间窗: 6 weeks
次要结局
- Change from baseline in visual acuity(10 weeks)