Visual Rehabilitation in Macular Degeneration: a Pilot Study on Biofeedback Training and Home-based Mobile Virtual-reality Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility of home-based IVR audiovisual stimulation
研究概览
简要总结
Following the degeneration of the macula and the loss of central vision, the patients naturally relocate the fixation point for high visual acuity peripherally, in an eccentric and healthy part of the retina (PRL), to compensate for visual impairments. However, in many cases, the PRL lands on a sub-optimal retinal area and becomes useless. Modern low-vision rehabilitation procedures for AMD patients include biofeedback training (BFT) to relocate the PRL to a healthy retinal patch and acquire better fixation skills. This study seeks to combine BFT with home-based immersive virtual-reality audiovisual stimulation and measure feasibility and potential effectiveness on oculomotor control and visual perception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCVA > 20/
- •Ability to follow the visual and auditory stimuli and training instructions.
- •Auditory test positive at 50Hz 25-60dBHL.
- •Home Wi-Fi access.
排除标准
- •Both eyes with media opacity that impairs microperimetry testing.
- •Inability to perform during testing and training.
- •Psychoactive drugs consumption.
- •3 consecutive VRISE scores < 25 at inclusion.
- •History of vertigo or dizziness
- •Prior vision rehabilitation interventions.
结局指标
主要结局
Feasibility of home-based IVR audiovisual stimulation
时间窗: 18 months
Feasibility objectives for our pilot study to be considered successful: 1. Number of patients completing the stimulation protocol: ≥ 13 out of 16 patients (81%) per group. 2. Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 13 sessions out of 16 (81%). 3. Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores \< 25: ≤ 3 per patient during the treatment period. 4. Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 3 (19%) during the treatment period. 5. Number of randomized patients per week: ≥ 3 patients.
次要结局
- Visual Acuity(from baseline to end of follow-up at 7 months)
- Quality of Life Scores(from baseline to end of follow-up at 7 months)
- Fixation stability(from baseline to end of follow-up at 7 months)
- Contrast Sensitivity(from baseline to end of follow-up at 7 months)
- Reading Speed(from baseline to end of follow-up at 7 months)
- Retinal Sensitivity(from baseline to end of follow-up at 7 months)
研究者
Michael Reber
Principal Investigator
University Health Network, Toronto