Nicotinamide Levels in Serum, Aqueous Humor, and Tear Film in Glaucoma and Correlations With Mitochondrial Damage-Associated Molecular Patterns (mtDAMPs) and Senescence-Associated Secretory Phenotype (SASP)

Launched by UNIVERSITÀ DEGLI STUDI 'G. D'ANNUNZIO' CHIETI E PESCARA · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the levels of a substance called nicotinamide (NAM) in the blood, eye fluids, and tears of patients with glaucoma. Glaucoma is a serious eye condition that can lead to permanent vision loss, and understanding how NAM relates to the disease could help researchers find better treatments. The trial aims to measure NAM levels at different stages of glaucoma and see how they connect with markers of eye damage and disease severity. Additionally, it will explore whether taking nicotinamide supplements can improve these levels in patients being treated for glaucoma.

To participate in the trial, individuals must be over 18 years old and have been diagnosed with open-angle glaucoma, which is the most common form of the disease. There are different groups for participants depending on whether their glaucoma is controlled or uncontrolled, and there are specific eye health requirements. Participants can expect to provide samples of their blood and eye fluids for analysis, contributing valuable information to help advance glaucoma research. It's important to note that some people may not be eligible due to certain health conditions or prior eye surgeries.

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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