Treatment of Homonymous Visual Loss With Digital Therapeutics, VIVID Brain, Visual Perceptual Learning Device (HOGWAND Trial) : Multi Center, Randomized, Single-blind (Evaluator), Superiority Prove, Prospective Confirmatory Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nunaps Inc
- 入组人数
- 93
- 试验地点
- 12
- 主要终点
- The sum of improved areas compared to baseline in the whole field
研究概览
简要总结
This study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain disease. Half of participants will receive visual perceptual training using the VIVID Brain. The other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years and older
- •At least 3 months after brain disease related to visual field defect
- •Verified brain disease in visual pathway related to occipital lobe, parietal lobe, temporal lobe or etc. using CT or MRI
- •Brain disease induced visual field defect
- •Able to use the VR(Virtual Reality) device
- •Able to use the app with a smart phone
- •Patient/legally authorized representative has signed the informed consent form
排除标准
- •Complete hemianopsia
- •Epilepsy, photosensitivity, Parkinson's disease
- •Bilateral visual field defect
- •Hemispatial neglect
- •Ophthalmologic disorder that may interfere the trial. (Ptosis of Eyelid, Corneal Opacity, Diabetic Retinopathy, Glaucoma, Macular Degeneration etc.)
- •Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.
- •Candidate for carotid endarterectomy or stenting
- •Received ophthalmologic surgery or laser surgery within 3 months, except for the cataract surgery
- •Pregnant or breast feeding
- •Participating in other clinical trial
- •Any other condition that, in the opinion of the investigator, precludes participation in the trial
研究组 & 干预措施
VIVID Brain
VIVID Brain, 5 times a week for 12 weeks
干预措施: VIVID Brain (Device)
No-treatment Control
No-treatment is administered during control period.
干预措施: No-treatment Control (Other)
结局指标
主要结局
The sum of improved areas compared to baseline in the whole field
时间窗: 12 weeks
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the whole field measured by Humphrey visual field test. The improved area ranges between 0 and 2,736 degree\^2, of which larger area indicates better outcome.
次要结局
- The sum of improved areas compared to baseline in the affected hemi-field(12 weeks)
- Changes in perimetric mean deviation relative to baseline in the whole field(12 weeks)
- Changes in mean total deviation relative to baseline in the affected hemi-field(12 weeks)