Prospective Pilot Study of the NEIVATECH Virtual Reality-based System to Improve Visual Function in Children with Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in distance best-corrected visual acuity (BCVA)
研究概览
简要总结
The NEIVATECH system has been designed to provide binocular vision training to 7-15 year old amblyopic children by discriminating Gabor patches presented with different contrast to each eye as a perceptual learning task.
详细描述
Due to the global impact of amblyopia, there is a medical and social need, and at the same time, a clear market niche, for the design and development of new therapies that can improve recurrence rates and non-compliance with conventional treatments. In this sense, the aim of this single-arm, multicentre, prospective pilot study is to examine the safety, acceptability and clinical efficacy of a novel Virtual Reality-based system designed to provide binocular vision training to 7-15 year old amblyopic children complementing the concepts of perceptual learning and dichoptic training with a gamification approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 7 and 15 years.
- •VA in the amblyopic eye < 0.1 logMAR units.
- •Interocular difference in VA ≥ 1 logMAR line.
- •Interocular difference in espherical equivalent ≥ 1 D.
- •Interpupillary distance (IPD) between 60.7 and 73.5 mm.
- •Use of best refractive correction for at least 2 months prior to inclusion.
- •Lack of response or therapeutic adherence to conventional occlusion therapy.
- •Willingness to attend all the active vision therapy sessions and/or visits of the study.
- •No history of previous treatment for amblyopia other than optimal refractive correction for at least 2 months prior to inclusion.
排除标准
- •Active eye disease.
- •Previous ocular surgery.
- •BCVA in the amblyopic eye of ≥ 0.70 logMAR.
- •Presence of cognitive impairment or neurological or psychiatric disorders.
- •Presence of irregular cornea due to astigmatism or ectatic corneal disease.
研究组 & 干预措施
Active group
18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system
干预措施: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system (Other)
结局指标
主要结局
Change in distance best-corrected visual acuity (BCVA)
时间窗: Baseline - 1 month
ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)
次要结局
- Change in near BCVA(Baseline - 1 month)
- Change in photopic contrast sensitivity function (CSF)(Baseline - 1 month)
研究者
Juan Francisco Arenillas Lara
Principal Investigator
Increase-Tech