A Prospective, Real-World, Multicenter Study to Support the Role of Ab-Interno Canaloplasty in Glaucoma Management.

Abstract

To assess real-world canaloplasty outcomes in glaucoma management using standardized data from an international registry. The iTrack Global Data Registry (iTGDR) is an ongoing prospective real-world multicenter observational study on ab-interno canaloplasty with the iTrack or iTrack Advance (Nova Eye Medical), with or without concomitant cataract surgery. Patients diagnosed with ocular hypertension or glaucoma (excluding angle-closure glaucoma). Analysis included eyes with a minimum 12 months follow-up from the iTGDR. Both standalone canaloplasty and canaloplasty combined with cataract surgery were included. Intraocular pressure (IOP) and glaucoma medications were assessed at baseline and postoperative follow-ups. Surgical success was defined according to the 2024 American Academy of Ophthalmology (AAO) criteria. IOP, number of glaucoma medications, and success rate at last follow-up (LFU). Two hundred and fifty-four patients (344 eyes) were followed over a mean of 20.5 ± 7.9 months (LFU). Following combined canaloplasty and phacoemulsification (n = 313 eyes), mean IOP and medication usage reduced from 17.2 ± 5.3 mm Hg and 2.1 ± 1.1 preoperatively to 14.1 ± 3.9 mm Hg and 1.3 ± 1.4 at LFU (P < .001); 61.9% of all combined eyes achieved success (increasing to 83% in eyes with baseline IOP > 18 mm Hg), while 43% of eyes became medication-free (vs 7% preoperatively). Standalone canaloplasty (n = 24 eyes) reduced IOP and medication usage from 20.2 ± 7.1 mm Hg and 2.3 ± 0.9 to 15.3 ± 6.3 mm Hg and 1.5 ± 1.6 (P < .01); 35% of eyes achieved success, and 46% of eyes became medication-free (vs none preoperatively). IOP and medication reductions were significant across glaucoma subtypes (primary and secondary open-angle glaucoma, ocular hypertension) and severities (P < .01 for all). The rate of additional glaucoma procedures was 4.9%, including laser procedures; no canaloplasty-related sight-threatening complications were reported. A loss of ≥2 lines of corrected distance visual acuity occurred in 7.3% of eyes, most commonly in association with pre-existing advanced disease or unrelated ocular comorbidities. In real-world clinical practice, iTrack canaloplasty significantly reduced IOP and medication burden with a favorable safety profile when performed alone or with phacoemulsification and in diverse glaucoma populations.