NCT03350919已完成不适用
Visual Restoration for Hemianopia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
研究概览
简要总结
The purpose of this research is to assess the efficacy of a visual training task on reducing the size of a visual field deficit caused by brain damage in adults, and its ability to improve visual functions in this patient population.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21-75 years old
- •Ability and willingness to sign informed consent
- •Willingness to participate in both the training and evaluation sessions
- •MRI or CT scan demonstrating lesion in the occipital lobe of the brain and/or affecting white matter tracts that provide visual input to the occipital lobe of the brain
- •Brain injury due to ischemic or hemorrhagic causes that occurs after age 18 and at least 90 days prior to screening visit
- •At least two reliable HVF's demonstrating good fixation and a stable homonymous incomplete (e.g., quadrantanopia or relative defect) or complete hemianopia
- •Reliable HVFs with repeat HVFs if randomization takes place more than 4 weeks after screening visit
- •A homonymous, contiguous visual deficit measured by the 24-2 HVF to be a minimum of two testing locations high and two testing locations wide, where impaired locations are any that measure a threshold of less than 15 dB.
- •Demonstration of good fixation on visual training task - able to fixate the small targets presented as fixation letters reliably for 1000ms with jitter over less than 1 degree of visual angle in any direction away from target edge
排除标准
- •Physical, neurological or mental disability that would interfere with study intervention
- •Concurrent participation in "vision therapy" other than standard occupational or physical therapy
- •Unreliable visual fields on prior testing, indicated by greater than 20% fixation losses, false positives, or false negatives.
- •Inability to discontinue medications judged to affect training and/or assessment (e.g., Ritalin, amphetamines, dopamines, or chemotherapeutic agents)
- •Physical condition likely to preclude completion of the clinical trial (e.g. end-stage or uncontrolled cancer, uncontrolled epilepsy, or end-stage heart disease)
- •Ocular or neurological condition that would interfere with training or assessment (e.g. damage to the optic nerves or lateral geniculate nucleus, any degenerative ocular condition)
- •Best corrected vision worse than 20/40
- •Impaired foveal Humphrey sensitivity as indicated by the HVF tests.
- •Presence of vision loss resulting from ocular disease or disorder
- •Presence of bilateral visual acuity loss from any source
- •Inability to demonstrate fixation stability on eye movement monitored testing
- •Inability to follow training instructions
结局指标
主要结局
24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
时间窗: 6 months
Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval.
次要结局
未报告次要终点
研究者
Steven Feldon
Professor and Chair of Ophthalmology
University of Rochester
研究点 (6)
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