Consistency in Standalone Canaloplasty Outcomes Using the iTrack Microcatheter.

Purpose: To study the consistency in outcomes of standalone canaloplasty performed via an ab-interno surgical technique in reducing intraocular pressure (IOP) and number of medications in uncontrolled open-angle glaucoma (OAG) eyes over a 12-month period. Methods: This retrospective multicenter case series included patients who underwent standalone canaloplasty via an ab-interno surgical technique using the iTrack microcatheter (Nova Eye, Inc., Fremont, USA) and had preoperative uncontrolled OAG (IOP≥18mmHg) along with no previous glaucoma surgery. The iTrack microcatheter is used to circumnavigate 360° and viscodilate Schlemm's canal. Consistency of IOP and medications reduction on an eye-by-eye basis were evaluated to understand the outcomes in each single eye. Results: Sixty-four eyes of 60 patients (age 71.5±13.4 years) were included. Six eyes (9%) that underwent additional glaucoma surgery were considered a failure and were subsequently excluded from analysis. At 12 months, IOP was reduced in 57 of the 58 (89%) remaining eyes; one eye had the same IOP with a reduced number of medications. Of the 57/58 eyes with a reduced IOP: 44 eyes (69%) required fewer medications; 12 eyes (19%) required the same number of medications. Of these 58 eyes, 78% of eyes had a ≥20% reduction in IOP compared to baseline; 69% eyes had a postoperative IOP ≤15 mmHg, and 86% eyes ≤18 mmHg at 12 months. Forty percent of the eyes were medication-free at 12 months compared to none at baseline. Conclusion: Canaloplasty performed via an ab-interno surgical technique as a standalone procedure consistently reduced IOP and glaucoma medications in almost all eyes.

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.

PRCIS: 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. PURPOSE: 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. METHODS: 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. RESULTS: 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±5.2 mm Hg (n=27) at baseline (no washout) to 14.6±3.3 mm Hg 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. CONCLUSIONS: 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.

Four-Year Efficacy and Safety of iTrack Ab-interno Canaloplasty as a Standalone Procedure and Combined with Cataract Surgery in Open-Angle Glaucoma.

PURPOSE: To evaluate the long-term effectiveness of ab-interno canaloplasty (ABiC), performed with the iTrack microcatheter (Nova Eye Medical, Fremont, CA, USA), in reducing intraocular pressure (IOP) as well as the number of required glaucoma medications in patients with open-angle glaucoma (OAG). METHODS: In this retrospective single-center consecutive case series, 27 eyes of 21 patients (mean age 77.3 ± 5.8 years) were treated with ABiC performed as a standalone procedure or combined with cataract surgery. Patients with uncontrolled IOP OAG or controlled IOP (≤ 18 mmHg) OAG with intolerance to medications or lack of compliance were included. Patients were followed for up to 4 years following the procedure. The iTrack microcatheter was used to perform a 360-degree circumferential intubation and viscodilation of Schlemm's canal. Primary efficacy endpoints included IOP and the number of glaucoma medications at 12, 24, 36, and 48 months after surgery. RESULTS: In all eyes, mean IOP and number of glaucoma medications were significantly reduced from 19.8 ± 5.2 mmHg and 1.9 ± 1.00 at baseline to 14.6 ± 3 mmHg and 0.9 ± 0.8, respectively, at the 48-month follow-up (p < 0.001). IOP was stable from 12 months to 48 months (p > 0.005). After 48 months, 39% of the eyes required zero medications compared to 3.7% at baseline, and 72.2% of eyes required only one medication or less. Of all eyes, 77.8% recorded an IOP ≤ 17 mmHg. No serious complications were recorded. CONCLUSION: iTrack ABiC performed as a standalone procedure or in combination with cataract surgery significantly reduced IOP and number of medications in patients with OAG up to 4 years after the procedure.

Clinical outcomes of canaloplasty via an ab-interno surgical technique using the iTrack device: a narrative review.

PURPOSE: This narrative review seeks to investigate intraocular pressure (IOP), glaucoma medication dependence and safety profile of canaloplasty performed via an ab-interno surgical technique using the iTrack canaloplasty microcatheter (Nova Eye Medical). METHODS: A literature search was performed in March 2022 using MEDLINE and EMBASE to identify all papers which performed ab-interno canaloplasty using the iTrack, either combined with phacoemulsification or as a standalone procedure in primary open angle glaucoma. IOP was the primary efficacy outcome. Secondary outcomes were glaucoma medication use and safety profile. RESULTS: The search demonstrated 170 results of which 9 studies were included which totaled 365 eyes. Both IOP and number of medications were reduced at 12-24 months. IOP decreased from 20.0 ± 2.5 mmHg preoperatively to 13.8 ± 0.6 and at 14.0 ± 0.9 at 12 and 24 months; the number of medications was reduced from 2.5 ± 0.5 preoperatively to 0.8 ± 0.4 and 0.9 ± 0.6 at 12 and 24 months postoperatively. Comparable results were observed in the iTrack-alone and iTrack + phaco groups: IOP was reduced from baseline 20.5 ± 1.9 and 19.6 ± 3.0 to 14.3 ± 1.1 and 13.9 ± 1.1 24 months postoperatively respectively. CONCLUSION: This review suggests that ab-interno canaloplasty as a standalone procedure or combined with phacoemulsification using the iTrack leads to a reduction in IOP and glaucoma medication use up to 24 months postoperatively.

Long-term effect of canaloplasty on intraocular pressure and use of intraocular pressure-lowering medications in patients with open-angle glaucoma.

PURPOSE: To assess the long-term safety and effectiveness of canaloplasty in reducing intraocular pressure (IOP) and use of IOP-lowering medications in eyes with open-angle glaucoma (OAG). SETTING: Surgical center (Augencentrum Köln, Köln, Germany). DESIGN: Retrospective study. METHODS: 206 eyes from 130 patients were included. Canaloplasty was performed using the VISCO360 or OMNI surgical system as a stand-alone procedure in 22 eyes and concomitantly with cataract extraction (CE) in 185 eyes with chronic OAG insufficiently controlled or intolerant to IOP-lowering medications. The number of hypotensive medications and IOP were recorded at baseline, day 1, week 1, month 1, month 3, and every 3 months thereafter, with the last follow-up visit at 36 ± 6 months postoperatively. Patients were stratified by baseline IOP (Group 1, IOP >18 mm Hg; Group 2, IOP ≤18 mm Hg). Treatment success in Group 1 was defined as a reduction in IOP and the use of IOP-lowering medications; Group 2 success was defined as maintenance of a lower IOP and a reduction in medication use. RESULTS: The preoperative mean IOP of both groups was 21.1 ± 8.8 mm Hg, with a mean of 2.0 ± 0.9 hypotensive medications. The primary success end point was met by 73% of patients, with a mean IOP reduction in Group 1 (131 eyes; 21.8 to 15.6 mm Hg, P < .0001) and a maintenance of IOP control in Group 2 (76 eyes; 15.4 to 13.9 mm Hg, P = .24). Medications decreased from 2.2 ± 0.9 to 0.9 ± 1.1 in Group 1 ( P = .024) and from 1.8 ± 0.8 to 0.7 ± 1.0 in Group 2 ( P = .003). CONCLUSIONS: Canaloplasty alone or in conjunction with CE with the VISCO360 or OMNI surgical system is a safe, tissue-sparing, and effective minimally invasive glaucoma surgery, using a clear corneal incision in phakic or pseudophakic eyes. Canaloplasty performed with both evaluated devices achieved statistically significant, consistent, and clinically meaningful reductions in IOP and use of IOP-lowering medications in adult patients with OAG. In the consistent cohort (n = 42), the IOP-lowering effect lasted up to 42 months, with ongoing data collection expected to describe long-term effectiveness of this intervention.

360° ab-interno Schlemm's canal viscodilation in primary open-angle glaucoma.

Purpose: To evaluate the safety and effectiveness of ab-interno microcatheterization and 360° viscodilation of Schlemm's canal (SC) using the VISCO360® Viscosurgical System in treatment of primary open angle glaucoma (POAG). Setting: Surgical center (Augencentrum Köln, Köln, Germany). Design: Retrospective analysis of 106 eyes from 71 consecutive patients. Methods: Ab-interno canal viscodilation (VISCO360®) with or without cataract extraction was performed in two groups of patients with mild-moderate POAG: Group 1 had a baseline intraocular pressure (IOP) ≥18 mmHg (n=72 eyes) and Group 2 had a baseline IOP <18 mmHg (n=34 eyes). IOP without washout was measured and number of IOP-lowering medications were documented at all visits. Effectiveness was determined by reduction in IOP and reduction in the number of IOP-lowering medications at 12±3 months from baseline. Safety was determined by the rate of adverse events (AEs) and secondary surgical interventions (SSI). Results: In Group 1, all eyes available at 12±3 months (n=72), had a 41.0% reduction in mean IOP (from 24.6±7.1 mmHg to 14.6±2.8 mmHg), 87% (n=62) of which showed an IOP reduction of ≥20% with no increase in IOP-lowering medications. In Group 2, all eyes (n=34) maintained their baseline IOP at all postoperative visits. In both groups, a significant decrease (>89%) in mean number of IOP-lowering medications was seen at 12 months with 86% of eyes completely off medication with no increase in IOP. The most common AE seen was hyphema (13%) and no eye required SSI during the study period. Conclusion: Ab-interno SC viscodilation (VISCO360) is safe and effective in lowering IOP and reducing hypotensive medications in patients with OAG.