Vision Restoration Training in Glaucoma - A Double-blind, Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Detection accuracy change in percent over baseline of the visual field
研究概览
简要总结
Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and methods are needed to achieve vision restoration. Behavioral vision restoration training (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise such a method.
Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT by daily one hour training for 3 months improves detection performance in perimetry compared to a vision discrimination task in the intact visual field sector.
详细描述
Design: Prospective, randomized, double-blind, placebo controlled trial. Setting: Ambulatory care and home training Participants: Volunteer sample of glaucoma patients (25-80 yrs old) with stable visual fields and well controlled intraocular pressure (IOP).
Intervention: Computer-based home training with VRT (n=15) or placebo discrimination training (n=15).
Main Outcome Measures: The primary endpoint is change in detection performance in High Resolution Perimetry (HRP). Secondary endpoints are 30° white/white and 30° blue/yellow near-threshold perimetry. Further measures are eye movements, vision-related quality of life (vQoL) as assessed with (NEI-VFQ) and health-related quality of life (hQoL) using SF-36 Health Survey-Short Form.
Investigators hypothesize that VRT will improve visual performance in glaucoma
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual filed defect caused by glaucoma
- •Presence of a reproducible and stable visual field defect inside 30° eccentricity in at least one eye in 2 consecutive ophthalmologic visits during the last 12 months before recruitment
- •Well controlled intraocular pressure (IOP), and (iv) age between 25 and 80 years
排除标准
- •History of any medical condition precluding scheduled study visits or completion of the study (e.g. unstable cardiovascular disease)
- •History of any chronic degenerative or chronic inflammatory disease that could affect the visual field (e.g. multiple sclerosis, tumor
- •History of trauma or any non-glaucoma ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration, macular detachment, vascular occlusion
- •Severe cognitive or motor impairments
- •Insufficient fixation ability
- •Photosensitivity
- •Intraocular surgery or laser treatment performed within the previous 12 months before recruitment; OR
- •Scheduled intraocular surgery
研究组 & 干预措施
vision restoration training
Vision restoration training (VRT): visual stimuli repetitively presented to stimulate areas of residual vision. The training consists of luminance increment stimuli similar to perimetry and the task isa simple detection task (pressing a key whenever a target stimulus was detected).
干预措施: vision restoration training (Behavioral)
Discrimination training
Discrimination training. Here, the stimulus is a line segment (bar) which is always presented within the central ±5° visual field in one of four possible random orientations: horizontal, vertical, oblique to the right or oblique to the left. If the patient has visual field defects in this central area, 80% of the stimuli are presented in the intact part of the training region. The task is to identify the orientation of the line segment and press, as fast as possible, one of 4 assigned buttons on the keyboard.
干预措施: Discrimination Training (Behavioral)
结局指标
主要结局
Detection accuracy change in percent over baseline of the visual field
时间窗: between baseline and 3 months of training
visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)
次要结局
- change in visual stimulus perimetric detection rate(between baseline and 3 months of training)
- improvement of reaction time(between baseline and 3 months of training)
研究者
Bernhard A. Sabel
Director, Principle Investigator and Study Director
University of Magdeburg