Comparing Cataract Surgery With and Without iTrack Advance Canaloplasty Device in Patients Aged 55 and Older With Mild to Moderate Primary Open-Angle Glaucoma

What this Trial Is About

Researchers are evaluating cataract surgery combined with ab-interno canaloplasty using the iTrack Advance canaloplasty device compared to cataract surgery alone in patients with mild to moderate primary open-angle glaucoma. This prospective, multicenter, randomized, single-masked clinical trial aims to assess the effects of these treatments on eye pressure and glaucoma medication use over a two-year period. Participants will be randomly assigned to one of two groups cataract surgery with ab-interno canaloplasty, which involves 360-degree microcatheterization and viscodilation of Schlemms canal using the iTrack Advance device, or cataract surgery alone. The study will monitor the impact of these procedures on intraocular pressure and the number of glaucoma medications needed. During the 24-month follow-up, participants will undergo regular assessments to measure changes in intraocular pressure and medication use at 12 and 24 months compared to baseline. The study will also track safety and treatment effects. Participants can expect scheduled visits to monitor eye health and study outcomes throughout their involvement.

Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma