Clinical Trial

Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

Enrolling by Invitation
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Summary
The goal of this study is to learn if combining minimally invasive glaucoma surgery (MIGS) procedures with different mechanisms of action increases the effectiveness of MIGS. The main question the study aims to answer is: Does combining viscodilation (a surgical technique, often used in glaucoma treatment, that involves using a high-viscosity, elastic gel to widen and open the Schlemm's canal, a main drainage channel in the eye) with the iTrack catheter, along with the Hydrus microstent, show better reduction in intraocular pressure than cataract surgery alone? Researchers will retrospectively review charts of patients who have open-angle glaucoma who have undergone combination Hydrus implantation and 360-degree iTrack canaloplasty with concomitant cataract surgery, who have at least 36 months of clinical follow-up data. Baseline demographic information and severity of glaucoma will be recorded, as will change from baseline yearly to three years in average optical coherence tomography (OCT) retina nerve fiber layer (RNFL) measurements and visual field (VF) pattern standard deviation. Safety outcomes and the percentage of eyes requiring secondary surgical intervention will be recorded at yearly time points.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-16.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-01-07
Trial Details
NCT Number NCT07073937
Lead Sponsor University of Utah
Collaborators: Alcon Research
Conditions Glaucoma, Open Angle, MIGS, Minimally Invasive Glaucoma Surgery, Canaloplasty, Intraocular Pressure (IOP), Cataract Surgery, Surgical Technique, Minimally Invasive Surgical Technique +1 more
Enrollment 100 participants
Start Date 2025-08-01
Primary Completion 2026-09-17 (estimated)
Study Completion 2026-11-04 (estimated)
Updated on ClinicalTrials.gov 2026-01-09