Visual Function Tests in Non-Exudative Age-Related Macular Degeneration and Normal Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Critical flicker fusion
研究概览
简要总结
The goal of this study is to assess a battery of visual function tests in subjects with non-exudative age-related macular degeneration
详细描述
Age-related macular degeneration (AMD) is one of the leading causes of visual impairment among elderly populations in developed countries. Majority of AMD patients (80%) suffer from the dry or non-exudative form of the disease. Currently there are no approved treatments for dry AMD. Clinical development of therapeutic agents for dry AMD is limited by slow progressing nature of the disease as well as the lack of sensitive endpoints to assess therapeutic efficacy. Visual acuity, the commonly used functional endpoint, remains minimally affected during early stages of dry AMD. Thus novel visual function endpoints, that can identify functional deficits during early stages of dry AMD prior to development of geographic atrophy, are needed. In the current study a battery of visual function tests will be evaluated in subjects with different stages of dry AMD and normal controls, to assess their sensitivity and feasibility as potential functional endpoints for dry AMD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Subjects Must:
- •Be 60 years of age or older;
- •Provide written informed consent;
- •Be willing and able to follow all instructions and attend the study visits;
- •Must be able to perform all study procedures;
- •Normal Subjects:
- •Have BCVA of 20/25 or better in the study eye;
- •Have no history or clinical evidence of AMD, retinal diseases or any other ocular pathologies in either eye;
- •AMD Subjects:
- •Have BCVA of 20/40 or better in the study eye;
- •Have a clinical diagnosis of non-exudative AMD in the study eye;
排除标准
- •All subjects must not have any of the below criteria
- •Have a diagnosis of wet AMD in the study eye;
- •Have any other hereditary or acquired retinal diseases in either eye ;
- •Have glaucoma or other optic nerve diseases in either eye;
- •Have corneal or other anterior segment diseases in either eye;
- •Have significant cataract in the study eye;
- •Have a history of ocular trauma or ocular surgery (other than cataract removal) in the study eye;
- •Have a history of uncontrolled systemic disease (e.g. poorly controlled hypertension or poorly controlled diabetes);
- •Have a history of seizures;
- •On psychotropic medications;
- •Any other symptoms or conditions that could, in the opinion of the investigator, interfere with study procedures.
结局指标
主要结局
Critical flicker fusion
时间窗: At study visit through study completion, an average of 2 years
Critical flicker fusion will be tested using a computer based test for different stimulus colors, white, red, green and blue. A wide range of luminance and contrast levels will be tested. The subject would be seated in front of the monitor. The non-study eye will be occluded. Subjects would be given adequate practice tests prior to performing the actual test. The stimulus will be presented on the monitor screen and the subject indicates perceiving the stimulus by pressing a test button.
次要结局
- Reading Tests(At study visit through study completion, an average of 2 years)
- Color vision function(At study visit through study completion, an average of 2 years)
- Dark adaptation(At study visit through study completion, an average of 2 years)
- Shape discrimination(At study visit through study completion, an average of 2 years)