A First-in-Human Study of the Efficacy and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-I).

Ophthalmology. Glaucoma
Philippe DenisIqbal Ike K Ahmed

Abstract

To describe the safety and efficacy of a novel, supraciliary, microinvasive glaucoma surgery drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in the study. Prospective, multicenter, interventional, single-arm trial. Twenty-six patients with primary open-angle glaucoma uncontrolled with 1 or more intraocular pressure (IOP)-lowering medications. Using an ab interno approach, 25 eyes were implanted successfully in a stand-alone procedure with a 5-mm long device made of biocompatible STAR material, which is soft and flexible silicone in a microporous, network design. Intraocular pressure, medication use, and other ocular parameters were evaluated before surgery, 1 day, 1 and 2 weeks, and 1, 3, and 6 months after surgery. Intraocular pressure reduction at 6 months compared with baseline analyzed using a paired t test. Safety evaluation entailed tabulation of the nature and frequency of adverse events. Mean baseline diurnal IOP was 23.2 mmHg (standard error, 0.6 mmHg) using a mean ± standard deviation of 2.0±1.1 IOP-lowering medication classes. During the 6-month follow-up period, mean IOP ranged from 10.0-16.3 mmHg (mean reductions, 6.9-13.2 mmHg or 31.0%-56.8%). Six months after surgery, mean diurnal IOP was 14.2 mmHg (st...Continue Reading

References

Nov 1, 1971·Experimental Eye Research·A Bill, C I Phillips
Apr 28, 1999·American Journal of Ophthalmology·C B TorisC B Camras
Sep 3, 2002·Survey of Ophthalmology·Robert N WeinrebPaul L Kaufman
Aug 5, 2003·Journal of Glaucoma·Akif OzdamarMurat Karacorlu
Dec 29, 2004·Survey of Ophthalmology·Chian-Huey HongRamesh S Ayyala
May 11, 2005·Ophthalmology·Don S MincklerBrian A Francis
Jan 17, 2012·American Journal of Ophthalmology·Steven J GeddeUNKNOWN Tube Versus Trabeculectomy Study Group
Jan 17, 2012·American Journal of Ophthalmology·Steven J GeddeUNKNOWN Tube versus Trabeculectomy Study Group
Jan 24, 2014·Advances in Therapy·Lilit VoskanyanUNKNOWN Synergy Study Group
Mar 10, 2015·American Journal of Ophthalmology·Julian García-FeijooTsontcho Ianchulev
May 28, 2016·Journal of Current Glaucoma Practice·Anthony Gigon, Tarek Shaarawy
Jul 28, 2016·Clinical & Experimental Ophthalmology·Antonio M FeaPaolo Frezzotti
Oct 1, 2016·Seminars in Ophthalmology·Courtney E Bovee, Louis R Pasquale
May 17, 2017·Survey of Ophthalmology·Michele FigusMarco Nardi
Sep 14, 2017·Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft·S König, C W Hirneiß
Oct 11, 2017·Journal of Cataract and Refractive Surgery·Michael D GreenwoodJohn P Berdahl
Feb 2, 2018·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·Sofia FiliMarkus Kohlhaas
Jan 1, 2016·Expert Review of Ophthalmology·Luke J SaundersLinda M Zangwill
Jun 13, 2018·Journal of Cataract and Refractive Surgery·Manjool ShahIqbal Ike K Ahmed
Aug 4, 2018·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Julian Garcìa-FeijooJaime E Dickerson

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