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

Not Applicable

Completed

• Conditions: Age-related Macular Degeneration; Elderly French Population
• Interventions: 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)

• Registration Number: NCT01918553
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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)

Study Timeline

• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Study Start: 2015-07-09
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subject in the study ALIENOR	Intra ocular Pressure (IOP)	-
Subject in the study ALIENOR	retinal imaging (OPTOMAP)	-
Subject in the study ALIENOR	visual acuity exams	-
Subject in the study ALIENOR	axial length (IOL master)	-
Subject in the study ALIENOR	clinical parameters	-
Subject in the study ALIENOR	retinophotography	-
Subject in the study ALIENOR	SD-OCT	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin; 🇫🇷 Bordeaux, France