Real-World Multicenter Evaluation of Ab-Interno Canaloplasty Using a New Canaloplasty Device with and without Concomitant Phacoemulsification in Uncontrolled Open-Angle Glaucoma: 12-Month Outcomes.

Abstract

Purpose: To report real-world outcomes of ab-interno canaloplasty using the second-generation iTrack Advance in patients with open-angle glaucoma (OAG).

Patients and methods: This retrospective, observational, multicenter study reviewed consecutive ab-interno canaloplasty procedures performed using the iTrack Advance (Nova Eye Medical, US) across 11 US sites between 2022 and 2024. Eligible eyes had mild-to-moderate OAG, uncontrolled baseline intraocular pressure (IOP) ≥18 mmHg and <36 mmHg and at least 12 months of follow-up. Outcome measures included IOP and topical medication burden at 1, 6 and 12 months postop. Secondary outcomes included surgical success according to American Academy of Ophthalmology (AAO) criteria. Safety outcomes included complications, visual field mean deviation (VF MD), and additional glaucoma procedures.

Results: Eighty-two eyes of 82 patients (mean age 72.0±7.5 years) were included; 78 (95%) underwent canaloplasty combined with phacoemulsification and 4 (5%) underwent standalone canaloplasty. IOP in combined eyes decreased significantly from 20.7±2.9 mmHg preoperatively to 15.0±3.8 mmHg at 12 months (-27%; p<0.001), and medication burden reduced from 1.45±1.2 to 1.06±1.2 (-26.5%; p=0.013). Success by AAO criteria was achieved in 64% of combined eyes. Among all 82 eyes, 85% achieved IOP ≤18 mmHg and 40% were medication-free. Postoperative complications were mild and transient, with no sight-threatening complications related to canaloplasty. VF MD remained stable at 12 months. One eye (1.2%) required an additional glaucoma procedure.

Conclusion: In real-world practice, ab-interno canaloplasty performed using iTrack Advance in mild-to-moderate uncontrolled OAG achieved significant and sustained reductions in IOP and medication burden over 12 months with a favorable safety profile.