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  • Preserflo Safety and Effectiveness in POAG

    By Megan Mulholland
    Selected by Henry D. Jampel, MD, MHS
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    Journal Highlights

    Ophthalmology Glaucoma, March/April 2022

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    Beckers et al. assessed the safety and effectiveness of the Preserflo microshunt in patients with primary open-angle glaucoma (POAG). They found that patients’ mean IOP and need for glaucoma medications dropped fol­lowing surgery; these reductions were significant and sustained over the two years of the study. In addition, no long-term, sight-threatening adverse events (AEs) were reported.

    For this prospective single-arm study, the researchers evaluated 81 patients (81 eyes) with a mean age of 64.4 years (range, 28-85). All had mild to severe POAG that was inadequately controlled on maximal tolerated medical therapy.

    The Preserflo shunt was implanted with adjunctive use of topical mito­mycin C (MMC) in two concentra­tions (0.2 and 0.4 mg/mL). The main outcome measure was IOP and overall success of the procedure at years 1 and 2. Secondary outcomes included need for glaucoma medications and inci­dence of adverse events at year 2.

    Mean IOP decreased from 21.7 ± 3.4 mm Hg at baseline to 14.5 ± 4.6 mm Hg at year 1 and to 14.1 ± 3.2 mm Hg at year 2. Overall success rates at years 1 and 2 (defined as no reoperations or pressure failures) were 74.1%. The mean number of medications decreased from 2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2, and 73.8% of patients were medication-free at this point. In a sub­group analysis based on MMC concen­trations, those in the 0.4 mg/mL group experienced greater reduction in IOP and need for medication.

    In the safety assessment, 55 of the 81 eyes were affected by AEs. All AEs resolved within 46 days, except for one that required surgical treatment. Eight patients underwent a bleb revision during the study, and five received nee­dling or postsurgical injection of the bleb with 5-fluorouracil.

    The researchers noted that at the time of the study, the Preserflo shunt had been newly approved in Europe; thus, participating surgeons had limited experience with the device. As a result, they said, further studies may be needed to confirm the results or to study the effects of different MMC concentrations.

    The original article can be found here.