6-Year Efficacy and Safety of iTrack Ab-Interno Canaloplasty as a Stand-Alone Procedure and Combined With Cataract Surgery in Primary Open Angle and Pseudoexfoliative Glaucoma.

Abstract

Significant reductions in intraocular pressure (IOP) and the number of medications are sustained up to 6 years postoperatively for eyes that underwent ab-interno canaloplasty using the iTrack microcatheter, either as a stand-alone procedure or combined with cataract surgery. The purpose of this study was to evaluate the long-term effectiveness of iTrack (Nova Eye Medical Inc.) ab-interno canaloplasty for reducing IOP and the number of glaucoma medications in patients with primary open angle (POAG) and pseudoexfoliative glaucoma. A retrospective single-center consecutive case series. Patients were treated with either ab-interno canaloplasty performed as a stand-alone procedure or combined with cataract surgery and were followed for up to 6 years. iTrack was used to circumferentially catheterize and viscodilate the Schlemm canal over 360 degrees. Primary efficacy endpoints included IOP and number of glaucoma medications at 12, 24, 36, 48, 60, and 72 months after surgery. Twenty-seven eyes of 22 patients, with a mean age of 76.9±6.3 years, were recruited. Mean IOP was reduced significantly from 19.9±5.2mmHg (n=27) at baseline (no washout) to 14.6±3.3mmHg at the 6-year follow-up (n=18; P <0.001). The number of medications was significantly reduced from 1.9±1 at baseline to 0.9±0.9 at 6 years (n=18; P =0.005). At all time points, there was no statistical difference between POAG (n=16) and pseudoexfoliative (n=11) eyes, nor between stand-alone procedures (n=4) and those combined with phacoemulsification (n=23). At 72 months, the mean reduction in IOP was 27% while 53% in the number of medications. No serious complications were recorded. iTrack ab-interno canaloplasty performed as a stand-alone procedure or in combination with cataract surgery significantly reduced IOP and number of medications in patients with POAG up to 6 years after the procedure. To the authors' knowledge, this is the longest ab-interno canaloplasty follow-up available in the literature.