Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

NCT ID: NCT07073937

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-11-04

Brief 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.

Conditions

Glaucoma, Open Angle; MIGS; Minimally Invasive Glaucoma Surgery; Canaloplasty; Intraocular Pressure (IOP); Cataract Surgery; Surgical Technique; Minimally Invasive Surgical Technique; Glaucoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Glaucoma patients

Patients from the Moran Eye Center who have open-angle glaucoma and have had a combination of Hydrus and 360-degree canaloplasty with concomitant cataract surgery, who have at least three years of follow-up data.

Retrospective chart review

Intervention Type: OTHER

Retrospective study; a total of approximately 100 subjects have been identified to have had minimum 36 months follow-up.

Interventions

Retrospective chart review

Retrospective study; a total of approximately 100 subjects have been identified to have had minimum 36 months follow-up.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Craig Chaya

Assistant Professor (Clinical)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Chaya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah John A. Moran Eye Center

Locations

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

186645

Identifier Type: -

Identifier Source: org_study_id