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:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT05191628
Eligibility Criteria:
Inclusion Criteria:
* Man or woman over 18 years of age, less than 75 years
* Macular Hole of all etiologies
* Patient with history of opened macular hole after previous pars plana vitrectomy
* Delay between previous surgery and inclusion (relapse or non-closing hole) \> 1 month
* Patient who received the study information and provided consent
* Patient who is a members or a beneficiary of a national health insurance plan
Exclusion Criteria:
* Ocular surgery other than the macular hole surgery in the prior 3 months
* Participation in other clinical studies in the prior 3 months
* Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
* Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
* Patient with uveitis or other active ocular inflammation or infection
* Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method
* Person deprived of liberty by judicial or administrative measures
* Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05191628
Study Brief:
Protocol Section:
NCT05191628