Efficacy and Safety of Visual Perceptual Learning Using the Nunap Vision for Improvement of Visual Field Defect Caused by Brain Damage: Multi Center, Superiority Prove, Double-blind, Randomized, Confirmatory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nunaps Inc
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline
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 damage. Half of participants will receive visual perceptual training using the Nunap Vision, while the other half will receive sham training using the Nunap Vision-C.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-80 years
- •Brain damage-induced visual field defect
- •At least 6 months after brain lesion
- •Minimum of 4 testing locations, where measured threshold ≤ 20dB
- •Verified visual pathway damage using CT or MRI
- •K-MMSE(Korean Mini Mental Status Examination) score ≥ 24
- •Visual acuity equal or better than 20/40
- •Able to use the investigational device
- •Patient/legally authorized representative has signed the informed consent form
排除标准
- •Unreliable Humphrey visual field test (any of fixation loss, false positive, false negative ≥ 20%)
- •Complete hemianopsia with sensitivity of the whole hemifield ≤ 3 dB
- •Epilepsy, photosensitivity, Parkinson's disease
- •Bilateral visual field defect
- •Hemispatial neglect
- •Ophthalmologic disorder that may interfere the trial
- •Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.
- •Candidate for carotid endarterectomy or stenting
- •Received ophthalmologic 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
Nunap Vision
Nunap Vision , 5 days a week for 12 weeks
干预措施: Nunap Vision (Device)
Nunap Vision-C
Nunap Vision-C, 5 days a week for 12 weeks
干预措施: Nunap Vision-C (Device)
结局指标
主要结局
Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline
时间窗: 12 weeks
Improved regions have luminance sensitivity that increased by equal or more than 6 dB relative to baseline. The improved area ranges between 0 and 972 degree\^2, of which larger area indicates better outcome.
次要结局
- Changes in Humphrey visual field mean deviation relative to baseline(12 weeks)
- Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline(12 weeks)