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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT07006194
Eligibility Criteria:
Group 1 Inclusion Criteria
* Age \> 18 years
* Diagnosis of open-angle glaucoma (primary open-angle glaucoma)
* Uncontrolled IOP (\> 21 mmHg as the mean of three measurements between 8-10 am and 16),
* Maximal medical therapy
* Perimetric-OCT and ophthalmic optic neuropathy criteria
* Indication for standalone or combined glaucoma surgery (any surgery allowing aqueous humor sampling: MIGS, MIBS, TRABE, DS, canal surgery, drainage tube implants, revision of surgical implant)
Group 2 and 4 Inclusion Criteria
* Age \> 18 years
* Diagnosis of open-angle glaucoma
* Controlled IOP (≤ 21 mmHg as the mean of three measurements between 8-10 am and 16) under medical therapy (excluding oral acetazolamide)
* Perimetric-OCT and ophthalmic optic neuropathy criteria.
Group 3 Inclusion Criteria:
* Age \>18 years
* IOP ≤ 21 mmHg
* Absence of perimetric-OCT and ophthalmic optic neuropathy criteria for glaucoma.
Exclusion Criteria for all groups
* Conditions and systemic therapies influencing NAM levels in biological fluids
* Concomitant ocular pathologies beyond glaucoma or cataracts
* Ocular therapies beyond hypotensive eye drops
* Prior ocular surgeries
* Secondary glaucomas (uveitic, silicone oil, traumatic, neovascular)
* End-stage glaucoma or severe glaucoma (\<-20 dB)
* Pregnancy and breastfeeding.
* (only for Group 3) family history of glaucoma and transient IOP spikes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07006194
Study Brief:
Protocol Section:
NCT07006194