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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT01918553
Collaborator
(none)
516
1
1
19.5
26.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
516 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors
Actual Study Start Date :
Jul 9, 2015
Actual Primary Completion Date :
Feb 23, 2017
Actual Study Completion Date :
Feb 23, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subject in the study ALIENOR

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin Bordeaux France 33000

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

  • Principal Investigator: Korobelnik Jean-François, University Hospital Bordeaux, France

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01918553
Other Study ID Numbers:
  • CHUBX 2012/31
First Posted:
Aug 7, 2013
Last Update Posted:
Apr 29, 2020
Last Verified:
Apr 1, 2020
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2020