Preserflo MicroShunt in refractory glaucoma: multicentre european results with up to three years of follow-up.

PURPOSE

To evaluate the real-world 3-year safety and efficacy of the Preserflo MicroShunt with mitomycin-C(MMC) in reducing intraocular pressure(IOP) and medications in patients with inadequately controlled glaucoma.

METHODS

This retrospective, multicentre, open-label study included consecutive patients who received the Preserflo MicroShunt implantation with MMC. We included patients with glaucoma (primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PXF), pigmentary dispersion glaucoma (PDG), normal-tension glaucoma (NTG), ocular hypertension (OHT), primary angle-closure glaucoma (PACG), uveitic glaucoma and other) inadequately controlled by medical therapy. The primary endpoints were the mean change in IOP and the number of IOP-lowering medications from baseline. Treatment success was defined as achieving IOP ≤ 18 mmHg and a 20% reduction from baseline with (qualified success) or without (complete success) the need for hypotensive medications.

RESULTS

A total of 242 patients had a mean baseline IOP of 25.3 ± 7.2 mmHg, reduced to 13.6 ± 4.7 mmHg at 1 year, 13.5 ± 5.1 mmHg at 2 years, and 13.1 ± 4.6 mmHg at 3 years (p < 0.0001). Medication burden decreased from 3.0 ± 1.0 at baseline to 0.55 ± 0.7 at 1 year, 0.72 ± 0.9 at 2 years, and 0.72 ± 0.9 at 3 years (p < 0.0001). Overall success rates at 1,2 and 3 years were 76.1%, 71.7% and 68.7% respectively. Common adverse events included hyphema (9 eyes), hypotony (5), and choroidal detachment (4). Over three years, the most common interventions included needling (22), surgical revision (29), and tube surgery (8).

CONCLUSIONS

In a real-world, multicentre setting, the Preserflo MicroShunt showed sustained IOP reduction and decreased medication use over 3 years, supporting its long-term safety and efficacy.