Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors

Conditions
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Elderly French Population, Age-related Macular Degeneration

Intervention / Treatment
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* Other: clinical parameters
* Other: visual acuity exams
* Other: retinophotography
* Other: SD-OCT
* Other: Intra ocular Pressure (IOP)
* Other: retinal imaging (OPTOMAP)
* Other: axial length (IOL master)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject participating in the study ALIENOR Affiliated to a social security Consent signed by the patient and the investigator Exclusion Criteria: - Health incompatible with one hour and a half ophthalmic examination
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject in the study ALIENOR<br> | Other: clinical parameters<br> <br> Other: visual acuity exams<br> <br> Other: retinophotography<br> <br> Other: SD-OCT<br> <br> Other: Intra ocular Pressure (IOP)<br> <br> Other: retinal imaging (OPTOMAP)<br> <br> Other: axial length (IOL master)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8-year incidence of late AMD (neovascular and/or atrophic) |  | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, epidemiology, risk factors, cohort study