Therapeutic Effects of Cataract Removal in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- Visual acuity, spatial contrast sensitivity, visual perception and cognition
研究概览
简要总结
Two very common aging-related diseases in older adults are Alzheimer's disease (AD) and cataracts. In elderly adults, these two diseases frequently occur in the same person. Although a cure for AD is currently unavailable, cataracts can be effectively treated with surgery in most people. The removal of cataracts has documented benefits for visual performance and for reducing accidents and falls. However, it has been the experience of the ophthalmologists, and others in the field, that patients, caregivers, and primary care doctors are reluctant to proceed with cataract surgery once an individual is given the diagnosis of AD. It is thought that cataract surgery will not improve the AD patient's quality of life, vision, and cognition. The investigators have designed this study to determine whether or not this is true.
详细描述
In this project, we propose to test the following clinical hypothesis, while addressing the primary and two secondary Specific Aims:
Hypothesis: Cataract removal produces measurable benefits in vision, perception, independent function, and quality of life in patients with co-morbid Alzheimer's disease.
Primary Specific Aim: To determine the effects of cataract removal on visual acuity, spatial contrast sensitivity, vision dependent functions, visual information processing, and quality of life in patients with Alzheimer's disease.
Secondary Specific Aims.
- To delineate the baseline characteristics of those patients who benefit most from the surgical intervention.
- To assess the thickness of the retinal nerve fiber layer (RNFL) with optical coherence tomography (OCT) in large samples of AD patients classified with mild or moderate dementia to determine if the thickness of the RNFL is associated with dementia severity, visual performance measures, and other patient characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 50 and older
- •clinical diagnosis of possible/probable Alzheimer's disease, or other type of dementia, mild (CDR-1), moderate (CDR-2), or severe (CDR-3)
- •at least 1 visually significant cataract
- •no ocular pathology
- •psychotropic drug must be with stable dosage for 30 days
排除标准
- •history of cataract removal
- •history of visually significant retinal, or optic nerve abnormalities
- •informed consent cannot be obtained from either subject or their research partner
- •subject shows evidence (in preoperative testing) of unstable cardiac or pulmonary function
- •history of uncontrolled diabetes or hypertension
- •history of stroke in areas known to affect cognition
- •life expectancy of less than 1 year
- •Down's Syndrome
研究组 & 干预措施
Immediate Cataract Surgery
Subjects randomly selected into the Immediate Surgery group will have their cataract surgery scheduled one month from the time their initial study visits are completed. The subjects will be followed monthly for a period of 6 months for surgical and non-surgical adverse events. At the 6-month point, subjects will receive a final comprehensive eye exam and neuropsychological testing. The research partners will complete final activities of daily living and resource utilization questionnaires.
干预措施: Immediate Cataract Surgery (Procedure)
Delayed Cataract Surgery
Subjects selected into the Delayed Surgery group will be asked to delay their surgery for 6 months after their initial study visits. At 6 months, this group will also undergo the same testing as the Surgery Group.
结局指标
主要结局
Visual acuity, spatial contrast sensitivity, visual perception and cognition
时间窗: Baseline and Month 6
次要结局
- Independent function(Baseline and Month 6)
- Quality of Life(Baseline and Month 6)
- Retinal Nerve Fiber Layer(Baseline, Months 2,4, & 6)
研究者
Grover C. Gilmore, PhD.
Principal Investigator
Case Western Reserve University