A 2-year study indicates that the Preserflo MicroShunt (Santen) is safe and effective in reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). Data from the study was presented in a poster at the Association for Research in Vision and Ophthalmology (ARVO) meeting.
The prospective study, conducted by researchers at the Carl Gustav Carus Hospital in Dresden, Germany, followed 26 eyes from POAG patients who underwent either the microshunt implantation or trabeculectomy. Results showed that both procedures effectively reduced mean diurnal IOP (mdIOP), with the Preserflo group experiencing a reduction from 16.3 mmHg to 11.8 mmHg and the trabeculectomy group from 17.3 mmHg to 11.2 mmHg. Additionally, both groups were able to discontinue glaucoma medications following the procedures. No statistically significant differences were found between the two groups in terms of mdIOP reduction, peak IOP, and IOP fluctuations. No severe adverse events were reported in either group.
These findings suggest that the Preserflo MicroShunt could serve as a viable alternative to trabeculectomy, offering similar outcomes with potentially fewer risks. Researchers said the study's nonrandomized design and careful matching of patients help ensure that the results are robust and applicable to a broader population. Preserflo received the CE mark in 2012 and is awaiting FDA approval in the United States.