Cataract Surgery In Conjunction With Ab-Interno Canaloplasty Using The Itrack Advance Device Compared To Cataract Surgery Only (Catalyst Study)
Published 2023 - 41st Congress of the ESCRS
Reference: PO0855 | Type: Free paper | DOI: 10.82333/s1c1-r934
Authors: Karl Mercieca* 1 , Simon Ondrejka 2 , Markus Kohlhaas 3 , Norbert Koerber 2
1Eye Clinic,University of Bonn,Bonn,Germany, 2Augencentrum Köln-Porz,Köln,Germany, 3St. Johannes Hospital,Dortmund,Germany
Purpose
To demonstrate the clinical effectiveness and safety profile of ab-interno canaloplasty utilizing the iTrack Advance (Nova Eye. Inc., Fremont, USA) in lowering intraocular pressure (IOP) and reducing the glaucoma medication burden in patients with mild to moderate primary open angle glaucoma (POAG).
Setting
Multicenter prospective clinical study.
Methods
This is an ongoing prospective, multicenter, randomized, single- masked, post-market clinical trial with follow-up through 12 months. A total of 75 eyes of 75 adult subjects with a diagnosis of mild to moderate Primary Open Angle Glaucoma, with a preoperative IOP of ≤ 25 mmHg while on 1- 4 ocular hypotensive medications and a visually significant cataract are planned to be enrolled in the study. Subjects are randomized in a 2:1 ratio and for undergoing either routine small incision cataract surgery followed by canaloplasty with the iTrack Advance (test group) or routine small incision cataract surgery (control group). Primary efficacy endpoints include mean IOP and mean number of glaucoma medications, as compared to baseline.
Results
We report the first 6 eyes of 6 patients (mean age 74.6±5.0 years) recruited up to March 2023, with up to 6-month follow-up: 5 eyes in the test group and 1 eye in the control group. In the iTrack Advance group, mean IOP was statistically significantly reduced from 17.4±4.2mmHg (n=5) at baseline to 12.4±2.8 mmHg at Day-1, 12.9±3.5 mmHg at Month-1 and 13.5±3.1 mmHg at Month-3. The mean number of medications was reduced from 1.25±0.46 at baseline to zero medications for all eyes in the test group at the time of the last follow-up visit. No complications or serious adverse events related to the device were reported.
Conclusions
Ab-interno canaloplasty in combination with cataract surgery significantly reduced IOP and medications burden. Outcomes in the control group (cataract surgery alone) will be assessed to confirm if there is a statistical significant difference with the test group.