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    Micro-stent may be stand-alone option when topical glaucoma therapy fails

    Long-term results showed improved pressure control, decreased medication burden

     

    The Duette Study

    The DUETTE Study is a prospective eight-site European trial that evaluated the micro-stent implantation as a stand-alone procedure for treating OAG in 65 patients refractory to topical medications, according to Dr. Nguyen, an investigator in the U.S.-based COMPASS randomized, controlled trial.

    Study outcomes were intra- and postoperative safety, as well as efficacy measured by IOP lowering, through 12 months. Patients had grades III/IV OAG and treated IOP between 21 and 35 mm Hg with between 1 to 4 medications. Patients were being considered for trabeculectomy at the time of enrollment.

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    The average patient age was 68.3 ± 10.5 years; 69% were women. The mean baseline IOP was 24.5 ± 2.8 mm Hg. Patients took a mean of 2.2 ± 1.1 medications (36.9% took 3 or more medications; 30.8% 2 or more medications; 26.2% 1 medication; and for 3.1% the number of medications was unknown). Most patients (63.1%) were phakic. All patients were followed for 12 months.

    The mean IOP decreased from the baseline of 24.5 to 16.7 mm Hg at 12 months, Dr. Nguyen noted. The mean percent change in IOP at 6 months postoperatively was –30% and at 12 months –32%.

    No serious major adverse events occurred. The most frequent adverse event was a transient increase in IOP over 30 mm Hg for more than 1 month postoperatively (n = 7 eyes). Transient hyphema developed in 4 eyes for less than 1 month postoperatively, cataracts progressed in 5 eyes with pre-existing cataracts, and 2 eyes each had a loss of best-corrected visual acuity of two lines or more and peripheral anterior synechiae. Eleven patients required secondary glaucoma surgery.

     

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