Mid-term evaluation of the new Glaukos iStent with phacoemulsification in coexistent open-angle glaucoma or ocular hypertension and cataract.

Abstract

To evaluate the mid-term efficacy and safety of the GTS-400-iStent combined with phacoemulsification in patients with cataract and open-angle glaucoma (OAG) or ocular hypertension (OHT). Prospective, non-comparative, uncontrolled, interventional case series study. Subjects underwent phacoemulsification and two GTS-400 implantation. Efficacy outcomes: intraocular pressure (IOP) and antiglaucoma medications. Safety outcomes: complications, best-corrected visual acuity and endothelial cell count (ECC). Follow-up was 1 year. 20 patients were enrolled (mean age: 75.1 ± 8.6 years). Mean medicated baseline IOP was 19.95 ± 3.71 mm Hg and 26 ± 3.11 mm Hg without medication. Mean final IOP was 16.75 ± 2.24, determining a final IOP decrease of 35.68% (9.42 ± 3 mm Hg; p<0.001), from baseline washout IOP. Mean number of medications fell from 1.3 ± 0.66 to 0.3 ± 0.57 (P<0.001). 75% of patients were off medications at one year. Mean ECC decreased from 2289.64 ± 393.5 cells/mm(2) to 1986.95 ± 520.58 cells/mm(2). Combined cataract surgery with implantation of GTS-400-iStent seems to be an effective and safe procedure.