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

NCT ID: NCT01918553

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-09
• Study Completion Date: 2017-02-23

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)

Conditions

Elderly French Population; Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Subject in the study ALIENOR

Group Type: EXPERIMENTAL

clinical parameters

Intervention Type: OTHER

visual acuity exams

Intervention Type: OTHER

retinophotography

Intervention Type: OTHER

SD-OCT

Intervention Type: OTHER

Intra ocular Pressure (IOP)

Intervention Type: OTHER

retinal imaging (OPTOMAP)

Intervention Type: OTHER

axial length (IOL master)

Intervention Type: OTHER

Interventions

clinical parameters

Intervention Type: OTHER

visual acuity exams

Intervention Type: OTHER

retinophotography

Intervention Type: OTHER

SD-OCT

Intervention Type: OTHER

Intra ocular Pressure (IOP)

Intervention Type: OTHER

retinal imaging (OPTOMAP)

Intervention Type: OTHER

axial length (IOL master)

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Korobelnik Jean-François

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin

Bordeaux, , France

Countries

France

References

Cougnard-Gregoire A, Delyfer MN, Korobelnik JF, Rougier MB, Malet F, Le Goff M, Dartigues JF, Colin J, Barberger-Gateau P, Delcourt C. Long-term blood pressure and age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):1905-12. doi: 10.1167/iovs.12-10192.

Reference Type: BACKGROUND

PMID: 23404120 (View on PubMed)

Merle B, Delyfer MN, Korobelnik JF, Rougier MB, Colin J, Malet F, Feart C, Le Goff M, Dartigues JF, Barberger-Gateau P, Delcourt C. Dietary omega-3 fatty acids and the risk for age-related maculopathy: the Alienor Study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):6004-11. doi: 10.1167/iovs.11-7254.

Reference Type: BACKGROUND

PMID: 21705687 (View on PubMed)

Delcourt C, Delyfer MN, Rougier MB, Amouyel P, Colin J, Le Goff M, Malet F, Dartigues JF, Lambert JC, Korobelnik JF. Associations of complement factor H and smoking with early age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5955-62. doi: 10.1167/iovs.10-6235.

Reference Type: BACKGROUND

PMID: 21642625 (View on PubMed)

Other Identifiers

CHUBX 2012/31

Identifier Type: -

Identifier Source: org_study_id