Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT03418220
Eligibility Criteria:
Inclusion Criteria:
* • GENERAL CRITERIA
* Man or woman with age over 60 years,
* Informed, written and signed consent by the patient and the investigator (no later than the day of inclusion) and before any investigation required by the research,
* Patient affiliated with social security,
* Patient willing and able to return to all clinical visits to the study and complete all related procedures.
• SPECIFIC CRITERIA
* Patient who need a cataract surgery,
* Patient presenting in both eyes:
the same type of AMD defined according to the international AREDS study modified (Ferris et al., 2013) no other ophthalmological pathology (control group).
Exclusion Criteria:
* • GENERAL CRITERIA
* Major patient under tutorship or curatorship or unable to express consent,
* Person deprived of liberty,
* Patient participating in an ongoing clinical trial during the inclusion visit,
• SPECIFIC CRITERIA
* Patient with chronic ophthalmic pathologies other than cataract and AMD defined in the modified international AREDS study included in the eye (Ferris et al., 2013),
* Patient who participated in a clinical trial of an experimental drug for atrophic AMD,
* Patient taking systemically drugs with immunomodulatory action: immunosuppressants, immunomodulators, chemotherapy or corticosteroids,
* Patient with systemic diseases modifying his immune status,
* Patient with a history of diabetes,
* Patient who received an anti-inflammatory eye treatment in both eyes in the 6 months preceding the surgery,
* Patient having dynamic phototherapy on the included eye.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03418220
Study Brief:
Protocol Section:
NCT03418220