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Purpose <p>To assess the efficacy and safety of PreserFlo MicroShunt (PMS) combined with mitomycin C in patients with medically treated primary open-angle glaucoma (POAG).</p> Study design <p> A retrospective observational study.</p> Methods <p>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 &lt; 15 mmHg (group 1), 15 ≤ IOP &lt; 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.</p> Results <p>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 (<i>n</i> = 10) and hyphema (<i>n</i> = 30). Needling was performed in 12 eyes, bleb revision in 2, tube re-insertion in 2, and insertion of a second tube in 1.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年1月18日

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  • Haruyuki Suzuki,
  • Rei Sakata,
  • Teruki Yamae,
  • Yukako Ishiyama,
  • Koichiro Sugimoto,
  • Hitomi Saito,
  • Megumi Honjo,
  • Shiroaki Shirato,
  • Makoto Aihara

摘要

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.