Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial
British Journal of Ophthalmology Oct 14, 2020
Denis P, Hirneiß C, Durr GM, et al. - In this prospective, multicentre, first-in-human, single-arm interventional study, researchers tested the safety and effectiveness of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma. They assessed stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. According to results, mean baseline IOP was 23.2 ± 2.9 mmHg on 2.0 ± 1.1 glaucoma medication ingredients and declined to 13.8 ± 3.5 mmHg (−40.7% decline) on 1.0 ± 1.3 medications 2 years after implantation. This first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system demonstrates encouraging IOP-lowering results and medication reduction over 24 months with few adverse events. No serious ocular adverse events or additional glaucoma surgery have been reported.
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