Safety and exploratory functional effects of topical cord blood serum in glaucoma patients.
📄 Abstract
To evaluate the safety, tolerability, and potential functional signals associated with cord blood serum (CBS) eye drops as adjunctive treatment in patients with open-angle glaucoma (OAG) already under intraocular pressure (IOP)-lowering therapy. In this monocentric prospective pilot study, 20 OAG patients (37 eyes) received topical CBS eye drops 8 times daily for 60 days, in addition to their standard hypotensive therapy. Ophthalmic evaluations were performed at baseline (V1), end of treatment (V4), and 60 days after discontinuation (V5), and included best-corrected visual acuity (BCVA), IOP, visual field (VF), pattern electroretinography (PERG), and retinal nerve fiber layer (RNFL) thickness. Statistical analyses assessed changes in functional and structural parameters. The treatment was well tolerated, with no adverse events and no significant changes in IOP or BCVA. Visual field mean deviation (MD), PERG parameters, and RNFL thickness showed non-significant variations across visits. A statistically significant RNFL thinning was observed in the infero-temporal sector between V1 and V4, although likely due to outlier effects. Linear mixed model analysis showed a significant increase in N95 amplitude at V5 compared to V4 when baseline MD was considered as a covariate. CBS eye drops were safe and well tolerated in this glaucoma population. Although no statistically significant functional or structural improvement was observed, some exploratory signals suggest potential neuroretinal involvement that warrants further investigation in larger, controlled studies.