Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C.
Abstract
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).
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…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 125 participants or records.
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