Glaucoma specialist, Glaukos Corporation, tells us that a study published recently in the Journal of Glaucoma showed that a single iStent® Trabecular Micro-Bypass Stent significantly reduced intraocular pressure (IOP) when implanted as a standalone procedure in pseudophakic eyes with open-angle glaucoma.
Glaukos is an ophthalmic medical technology company, focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma.
The company’s iStent was approved by the U.S. FDA in June 2012 and is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication. Made of surgical-grade non-ferromagnetic titanium that is coated with heparin, the iStent is approximately 1.0 mm long and 0.33 mm wide. Glaukos believes it is the smallest medical device ever approved by the FDA.
In this retrospective, consecutive case series, researchers from the University of South Dakota Sanford School of Medicine and Sioux Falls-based Vance Thomson Vision evaluated iStent procedure outcomes in 42 pseudophakic eyes (those in which the natural lens has previously been removed and replaced with an intraocular lens).
Patients had preoperative mean IOP of 20.26 mm Hg.
In 21 eyes followed for two years, mean medicated IOP decreased 6.64 mm Hg to 13.62 mm Hg, or 33%.
In total, 96% of study patients with preoperative medicated IOP ≥ 19 mm Hg achieved an IOP reduction at their last collected follow-up. With a low rate of postoperative IOP spikes and only one patient requiring additional glaucoma surgery, the safety profile was favorable. In order to mimic the device’s actual clinical use, study researchers enrolled patients with primary open-angle glaucoma, normal tension glaucoma and ocular hypertension, with no other exclusion criteria.
“While multiple studies and years of real-world experience have demonstrated the ability of iStent to achieve sustained IOP reductions when used in combination with cataract surgery, we wanted to explore the IOP-lowering performance of iStent as a sole procedure in pseudophakic eyes,” said John P. Berdahl, MD, who performed all of the procedures evaluated in the study.
“In this series of iStent procedures occurring between October 2012 and May 2015, we recorded IOP reductions at one and two years postoperatively that were both clinically and statistically significant.”
Dr. Berdahl added, “These types of results are important to glaucoma surgeons and patients because landmark studies such as the Early Manifest Glaucoma Trial have shown that every 1 mm Hg improvement in IOP can reduce the likelihood of disease progression.”
Source: Business Wire