Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

Launched by UNIVERSITY OF UTAH · Jul 16, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat open-angle glaucoma, a common eye condition that can increase pressure inside the eye and potentially lead to vision loss. Researchers want to see if combining two minimally invasive surgeries—the Hydrus microstent (a tiny device placed in the eye to help fluid drain) and a 360-degree canaloplasty using a special catheter that widens the eye’s drainage canal—along with cataract surgery, works better to lower eye pressure than cataract surgery alone. They will review medical records of patients who had these combined procedures and have at least three years of follow-up to see how well the treatment controlled eye pressure, protected the optic nerve, and maintained vision over time.

People who might join this study are adults aged 65 to 74 with open-angle glaucoma at different stages (mild, moderate, or severe) who have already had the combined Hydrus and canaloplasty surgery along with cataract removal and have three years of follow-up data available. Participants should not have had other specific eye surgeries, such as corneal grafts or previous glaucoma surgeries. During the study, researchers will look at eye pressure levels, nerve health using imaging tests, vision tests, and any side effects or need for additional treatments. This study aims to find safer and more effective ways to manage glaucoma and protect eyesight.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with open angle glaucoma (mild, moderate or severe as defined below) who have undergone combined Hydrus and 360 degree canaloplasty with concomitant cataract surgery with at least 3-year follow-up data
• • Mild: Definite optic disc, RNFL, or macular imaging abnormalities consistent with glaucoma and a normal visual field as tested with standard automated perimetry (SAP)
• • Moderate: Definite optic disc, RNFL, or macular imaging abnormalities consistent with glaucoma, and visual field abnormalities in one hemifield that are not within 5 degrees of fixation as tested with SAP
• • Severe: Definite optic disc, RNFL, or macular imaging abnormalities consistent with glaucoma, and visual field abnormalities in both hemifields and/or loss within 5 degrees of fixation in at least one hemifield as tested with standard automated perimetry (SAP)
• • Patients who have had prior selective laser trabeculoplasty (SLT) are allowed
• Exclusion Criteria:
• • Prior corneal graft (penetrating Keratoplasty \[PKP\], deep anterior lamellar keratoplasty \[DALK\], Descemet's Stripping Automated Endothelial Keratoplasty \[DSAEK\], Descemet membrane endothelial keratoplasty \[DMEK\]) \& refractive surgery
• • Prior retinal surgery
• • Prior MIGS or incisional glaucoma surgery
• • Angle closure glaucoma and other secondary glaucoma