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Introduction <p>The PRESERFLO MicroShunt is an 8.5-mm-long (70-µm lumen) controlled ab externo filtration surgery device made from poly[styrene-block-isobutylene-block-styrene] (SIBS). Three prospective, open-label clinical trials (ClinicalTrials.gov Identifiers: NCT00772330; NCT01563237; NCT02177123) evaluated the 2-year effectiveness and safety of MicroShunt implantation plus mitomycin C (MMC). This pooled analysis compared outcomes in patients receiving 0.2 or 0.4&#xa0;mg/ml MMC during MicroShunt implantation.</p> Methods <p>Patients aged 18–85&#xa0;years with primary open-angle glaucoma (intraocular pressure [IOP] 18–35&#xa0;mmHg) uncontrolled on maximal tolerated medical therapy and/or where glaucoma progression warranted surgery who underwent MicroShunt implantation with/without cataract surgery, and with adjunctive use of 0.2 or 0.4&#xa0;mg/ml MMC. Two-year outcomes included changes in IOP and glaucoma medications, complete success rates (IOP ≥ 6 to &lt; 14&#xa0;mmHg or ≥ 20% reduction, without medications), and rates of procedure/device-related adverse events (AEs) and serious AEs (SAEs).</p> Results <p>Of the 125 included patients, 58 received 0.2&#xa0;mg/ml MMC and 67 received 0.4&#xa0;mg/ml MMC). Mean percent reduction in IOP was significantly greater in patients receiving 0.4 than 0.2&#xa0;mg/ml MMC (− 40.9% vs. − 34.5%, <i>P</i> &lt; 0.05). Mean glaucoma medication use was reduced to a lower level between baseline and year 2 in the 0.4 than in the 0.2&#xa0;mg/ml MMC group. At year 2, the percentage of medication-free patients (85.2% vs. 58.0%, <i>P</i> &lt; 0.01) and the complete success rates (71.6% vs. 48.3%, <i>P</i> &lt; 0.01) were significantly higher in the 0.4 than in the 0.2&#xa0;mg/ml MMC group. Rates of procedure/device-related AEs and SAEs did not differ significantly in the two groups (<i>P</i> &gt; 0.05).</p> Conclusions <p>IOP and glaucoma medication use at year 2 were lower, and complete success rate was higher, in patients administered 0.4&#xa0;mg/ml than 0.2&#xa0;mg/ml MMC. Although there is no consensus on the optimal concentration of MMC, these findings may guide surgeons until further evidence from controlled trials becomes available.</p>

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Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月23日

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  • Julián Garcia-Feijoo,
  • Juan F. Batlle,
  • Florent Aptel,
  • Yves Lachkar,
  • Isabelle Riss,
  • Omar Sadruddin,
  • Tuan Nguyen,
  • Henny J. M. Beckers

摘要

Introduction

The PRESERFLO MicroShunt is an 8.5-mm-long (70-µm lumen) controlled ab externo filtration surgery device made from poly[styrene-block-isobutylene-block-styrene] (SIBS). Three prospective, open-label clinical trials (ClinicalTrials.gov Identifiers: NCT00772330; NCT01563237; NCT02177123) evaluated the 2-year effectiveness and safety of MicroShunt implantation plus mitomycin C (MMC). This pooled analysis compared outcomes in patients receiving 0.2 or 0.4 mg/ml MMC during MicroShunt implantation.

Methods

Patients aged 18–85 years with primary open-angle glaucoma (intraocular pressure [IOP] 18–35 mmHg) uncontrolled on maximal tolerated medical therapy and/or where glaucoma progression warranted surgery who underwent MicroShunt implantation with/without cataract surgery, and with adjunctive use of 0.2 or 0.4 mg/ml MMC. Two-year outcomes included changes in IOP and glaucoma medications, complete success rates (IOP ≥ 6 to < 14 mmHg or ≥ 20% reduction, without medications), and rates of procedure/device-related adverse events (AEs) and serious AEs (SAEs).

Results

Of the 125 included patients, 58 received 0.2 mg/ml MMC and 67 received 0.4 mg/ml MMC). Mean percent reduction in IOP was significantly greater in patients receiving 0.4 than 0.2 mg/ml MMC (− 40.9% vs. − 34.5%, P < 0.05). Mean glaucoma medication use was reduced to a lower level between baseline and year 2 in the 0.4 than in the 0.2 mg/ml MMC group. At year 2, the percentage of medication-free patients (85.2% vs. 58.0%, P < 0.01) and the complete success rates (71.6% vs. 48.3%, P < 0.01) were significantly higher in the 0.4 than in the 0.2 mg/ml MMC group. Rates of procedure/device-related AEs and SAEs did not differ significantly in the two groups (P > 0.05).

Conclusions

IOP and glaucoma medication use at year 2 were lower, and complete success rate was higher, in patients administered 0.4 mg/ml than 0.2 mg/ml MMC. Although there is no consensus on the optimal concentration of MMC, these findings may guide surgeons until further evidence from controlled trials becomes available.