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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Elderly French Population
Age-related Macular Degeneration

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01918553
CHUBX 2012/31

Details and patient eligibility

About

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

Full 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)

Enrollment

516 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

516 participants in 1 patient group

Subject in the study ALIENOR
Experimental group
Treatment:
Other: retinal imaging (OPTOMAP)
Other: retinophotography
Other: Intra ocular Pressure (IOP)
Other: clinical parameters
Other: visual acuity exams
Other: SD-OCT
Other: axial length (IOL master)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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