Preserflo MicroShunt: Efficacy and Endothelial Cell Density.

Prcis: A main safety concern associated with new glaucoma implants is corneal endothelial cell loss, which could even be observed in already established procedures.

Purpose: The purpose of this study was to evaluate the efficacy and corneal safety, especially corneal endothelial cell loss (ECL), after Preserflo MicroShunt implantation.

Methods: A monocentric, prospective clinical observational study of patients with a follow-up of at least 12 months who underwent Preserflo MicroShunt implantation at the Department of Ophthalmology, University Hospital of Düsseldorf, Germany, between January 2020 and October 2021. Endothelial cell density (ECD), the distance between the tip of the implant and the corneal endothelium, and the success of the surgery were analyzed.

Results: In total, 14 eyes of 12 patients were included. After a mean follow-up of 20±2.7 months intraocular pressure was significantly reduced by 8.2 mm Hg (P=0.0041); in 28.6% of patients, a revision surgery was necessary. Reduction of preoperative and follow-up ECD was not statistically significant (ECL of 45 cells/mm2, ECDpreoperative=2074±703.6 cells/mm2, ECDlast follow-up=2029±742.3 cells/mm2, P=0.42). A longer intracameral shunt tube length correlated significantly with a higher distance between the shunt tip and corneal endothelium (r=0.61, P=0.036).

Conclusions: Preserflo MicroShunt effectively lowered intraocular pressure without substantial ECL after a minimum follow-up period of 17 months.