Short-term efficacy and safety of PreserFlo MicroShunt in Japanese patients with medically treated primary open-angle glaucoma.

PURPOSE: To assess the efficacy and safety of PreserFlo MicroShunt (PMS) combined with mitomycin C in patients with medically treated primary open-angle glaucoma (POAG).

STUDY

DESIGN

A retrospective observational study.

METHODS

The study examined 83 eyes from 83 patients with medically treated glaucoma surgery naive POAG. Preoperative intraocular pressure (IOP) was stratified into three groups: IOP < 15 mmHg (group 1), 15 ≤ IOP < 21 mmHg (group 2), and IOP ≥ 21 mmHg (group 3). IOP levels at week 1, month 1, month 3, and month 6 were evaluated using a linear mixed model, and Kaplan-Meier survival analysis was employed to assess the complete success rate (30% IOP reduction without any medications or interventions) of IOP management. The postoperative complications and interventions were also evaluated.

RESULTS

Overall, the mean IOP decreased from 19.2 ± 7.4 mmHg to 11.3 ± 3.1 mmHg, representing a 41% IOP reduction. Especially, in group 1 (mean IOP of 12.8 mmHg), IOP decreased to 10.3 mmHg, achieving a reduction rate of 20%. Overall, 51% (95% confidence interval [CI] 41-62%) of the patients maintained a ≥ 30% IOP reduction (complete success). Minor complications included hypotony (n = 10) and hyphema (n = 30). Needling was performed in 12 eyes, bleb revision in 2, tube re-insertion in 2, and insertion of a second tube in 1.

CONCLUSIONS

PMS demonstrated significant efficacy in reducing IOP in patients with POAG reagrdless of its preoperative IOP levels. No serious complications affecting the VA were observed.