A 12-month randomized comparison of PRESERFLO microshunt implantation and trabeculectomy in primary open-angle and pseudoexfoliation glaucoma

Glaucoma is a leading cause of irreversible blindness worldwide, and effective intraocular pressure (IOP) reduction remains the cornerstone of its management. This randomized clinical trial aimed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) versus MMC-assisted trabeculectomy (TE) in patients with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PEXG) over a 12-month follow-up. A total of 99 patients were randomized to PMS ( n = 51) or TE ( n = 48). The primary endpoint was IOP reduction, while secondary outcomes included medication use, surgical success, complications, and filtering bleb morphology assessed by anterior segment optical coherence tomography (AS-OCT). In the early postoperative period, IOP was significantly lower in the PMS group; however, TE demonstrated superior long-term efficacy, with significantly lower IOP at 3 and 12 months and greater percentage reduction from baseline. Complete surgical success at 6 months was significantly higher in the TE group, while qualified success rates were comparable between groups throughout follow-up. No significant differences were observed in complication rates or medication use. In the TE group, bleb morphology parameters correlated negatively with IOP, whereas no such relationship was found in the PMS group. In conclusion, while PMS provides favorable early postoperative IOP control, TE remains more effective in achieving sustained IOP reduction over time, with comparable safety profiles. Trial registration: This trial was retrospectively registered at ClinicalTrials.gov (Identifier: NCT07496957).