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

Primary Purpose

Elderly French Population, Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
clinical parameters
visual acuity exams
retinophotography
SD-OCT
Intra ocular Pressure (IOP)
retinal imaging (OPTOMAP)
axial length (IOL master)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Elderly French Population focused on measuring AMD, epidemiology, risk factors, cohort study

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subject in the study ALIENOR

Arm Description

Outcomes

Primary Outcome Measures

8-year incidence of late AMD (neovascular and/or atrophic)

Secondary Outcome Measures

best-corrected visual acuity (ETDRS methodology) measured in visit 1 and 2 years later with ETDRS methodology

Full Information

First Posted
July 8, 2013
Last Updated
April 28, 2020
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01918553
Brief Title
Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors
Acronym
ECLAIR
Official Title
Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2015 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly French Population, Age-related Macular Degeneration
Keywords
AMD, epidemiology, risk factors, cohort study

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subject in the study ALIENOR
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
clinical parameters
Intervention Type
Other
Intervention Name(s)
visual acuity exams
Intervention Type
Other
Intervention Name(s)
retinophotography
Intervention Type
Other
Intervention Name(s)
SD-OCT
Intervention Type
Other
Intervention Name(s)
Intra ocular Pressure (IOP)
Intervention Type
Other
Intervention Name(s)
retinal imaging (OPTOMAP)
Intervention Type
Other
Intervention Name(s)
axial length (IOL master)
Primary Outcome Measure Information:
Title
8-year incidence of late AMD (neovascular and/or atrophic)
Time Frame
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 Measure Information:
Title
best-corrected visual acuity (ETDRS methodology) measured in visit 1 and 2 years later with ETDRS methodology
Time Frame
at day 0 (inclusion) and year 2 after inclusion (end of study)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korobelnik Jean-François
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23404120
Citation
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.
Results Reference
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PubMed Identifier
21705687
Citation
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.
Results Reference
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PubMed Identifier
21642625
Citation
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.
Results Reference
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Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors

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