Twelve-Month Safety Profile of PreserFlo MicroShunt on Corneal Endothelium in Glaucoma Subtypes

PreserFlo MicroShunt implantation alone may be well tolerated for the corneal endothelium across glaucoma subtypes over 12 months, whereas combination with cataract extraction may increase the risk of endothelial compromise, with a tendency toward a more pronounced reduction in pseudoexfoliation glaucoma.

To evaluate the impact of PreserFlo MicroShunt (PMS) implantation on corneal endothelial cell density (ECD) over 12 months, stratified by glaucoma subtype and surgical procedure.

This retrospective cohort study included 103 eyes with primary open angle glaucoma, pseudoexfoliation glaucoma (PEXG), and secondary open angle glaucoma without PEXG, all undergoing PMS implantation [either alone or combined with cataract extraction (PMS-CE)] between August 2022 and December 2023. Changes in ECD, coefficient of variation (CV), and hexagonal cell percentage (HEX) were assessed. Firth logistic regression was used to evaluate risk factors for >10% ECD loss. Subgroup analyses were performed by surgical procedure.

No significant within-group ECD, CV, or HEX changes were observed at 12 months in any glaucoma subtype. Thirteen eyes (12.6%) exhibited >10% ECD loss, predominantly in the PMS-CE group. Multivariate analysis identified PMS-CE as a significant risk factor [odds ratio (OR): 12.1; 95% CI: 2.69-75.0; P <0.001]. In the PMS-CE subgroup, PEXG was associated with greater risk of ECD loss (OR: 9.39; CI: 1.19-125.0; P =0.033).

PMS-alone demonstrated a favorable safety profile for the corneal endothelium across glaucoma subtypes. However, PMS-CE may pose an elevated risk of endothelial compromise, with a tendency toward a more pronounced reduction in PEXG eyes.