Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 516
- 试验地点
- 2
- 主要终点
- 8-year incidence of late AMD (neovascular and/or atrophic)
研究概览
简要总结
Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised countries. There are few epidemiological studies on the incidence of this disease. Studying the incidence of AMD in an elderly French population and identifying the predisposing factors is very important to allow a major advance in the epidemiological knowledge of AMD. This study will contribute to the identification of the clinical, genetic and modifiable parameters associated at the risk of developing AMD. This could result in means prevention as well as in the identification of subjects as high risk of AMD
详细描述
Age-related Macular Degeneration is the most cause of blindness in the industrialised countries. There are few French epidemiological data on this disease. Worldwide, studies have included a small number of very old subjects. Thus, it is important to estimate the AMD incidence in an elderly French population, in order to evaluate more precisely the number of cases in the French population. Besides, some clinical, genetic and modifiable parameters predisposing to the AMD are under study. The aim of the ECLAIR project is to study the 8-year incidence of AMD in an elderly French population and to identify the predisposing factors. It is based on an existing cohort study (ALIENOR) in which some clinical, genetic and modifiable data were collected at baseline, 2 and 4 years. It is the only cohort study performed in France in this field since fifteen years in parallel with another one performed in Dijon according to the same methodology. It is important to extend the study to 8 years in order to have a sufficient statistical power for the identification of predisposing factors. In the ECLAIR study, there is no treatment. The subjects will be followed during 2 years (6 and 8 years after baseline of the Alienor study). The visit 1 (A0) will be the inclusion visit where the subjects will sign the inform consent and will perform ophthalmological examinations. The subjects will come back 2 years later for the visit 2 (A2). In this second visit, the ophthalmological examinations will be the same that is: measure of clinical parameters, measurement of visual acuity exams, retinophotography,spectral domain optical coherence tomography (SD-OCT), intraocular pressure, retinal imaging (OPTOMAP), axial length (IOL master)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject participating in the study ALIENOR
- •Affiliated to a social security
- •Consent signed by the patient and the investigator
排除标准
- •- Health incompatible with one hour and a half ophthalmic examination
研究组 & 干预措施
Subject in the study ALIENOR
干预措施: Intra ocular Pressure (IOP) (Other)
Subject in the study ALIENOR
干预措施: clinical parameters (Other)
Subject in the study ALIENOR
干预措施: visual acuity exams (Other)
Subject in the study ALIENOR
干预措施: retinophotography (Other)
Subject in the study ALIENOR
干预措施: SD-OCT (Other)
Subject in the study ALIENOR
干预措施: retinal imaging (OPTOMAP) (Other)
Subject in the study ALIENOR
干预措施: axial length (IOL master) (Other)
结局指标
主要结局
8-year incidence of late AMD (neovascular and/or atrophic)
时间窗: at day 0 (inclusion in ECLAIR study and 6 years after inclusion in ALIENOR cohort) and year 2 after inclusion (end of ECLAIR study and 8 years after inclusion in ALIENOR cohort)
次要结局
- best-corrected visual acuity (ETDRS methodology) measured in visit 1 and 2 years later with ETDRS methodology(at day 0 (inclusion) and year 2 after inclusion (end of study))
