Outcomes and Risk Factors for Failure After PRESERFLO™ MicroShunt Implantation in a Multicenter Japanese Cohort.

Abstract

To evaluate real-world outcomes of PRESERFLO MicroShunt (PMS) implantation and identify risk factors for surgical failure in a large multicenter Japanese cohort. Multicenter, retrospective cohort study. This study involved 699 patients (N = 856 eyes) who underwent PMS implantation with ≥ 3 months of follow-up postsurgery. The main outcome measures were 12-month-postoperative complete and qualified surgical success and risk factors for failure. Surgical success was defined by three criteria: A, B, and C corresponded to the intraocular pressure (IOP) thresholds of ≤ 18, ≤15, and ≤ 12 mm Hg, respectively, each combined with a ≥ 20% reduction from baseline. Outcomes were categorized as complete success (CS, without medication) or qualified success (QS, with or without medication). Kaplan-Meier and Cox regression analyses were used to evaluate success rates and risk factors. Median IOP decreased from 18 mm Hg preoperatively to 11 mm Hg at 12 months postoperatively, with median medications reduced from 4 to 0 (P < .001). At 12-months postoperative, CS rates were 69.5%, 67.6%, and 59.4% under Criteria A, B, and C, respectively; corresponding QS rates were 81.0%, 77.3%, and 66.0%, respectively. Risk factors for CS failure across all three criteria included greater medication use and prior or concomitant cataract surgery, whereas older age and posterior tube fixation were protective. PMS implantation achieved sustained IOP reduction, decreased medication use, and favorable safety in a large Japanese cohort, underscoring the importance of patient selection and surgical technique in optimizing outcomes.