Aims 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).

Methods 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.

Results 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/mm² to 1986.95±520.58 cells/mm².

Conclusions Combined cataract surgery with implantation of GTS-400-iStent seems to be an effective and safe procedure.