Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Glaucoma; Glaucoma, Open Angle; Cataract Surgery; Surgical Technique; Minimally Invasive Surgical Technique; Intraocular Pressure (IOP); Canaloplasty; MIGS; Minimally Invasive Glaucoma Surgery
• Intervention / Treatment: Other: Retrospective chart review

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah John A. Moran Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Retrospective chart review; Retrospective study; a total of approximately 100 subjects have been identified to have had minimum 36 months follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of surgical success at three years.	Surgical success is defined as a decrease of one or more glaucoma medications from baseline without an increase in medicated intraocular pressure (IOP).	From baseline to three years post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean decrease in IOP from baseline at three years		From baseline to three years post-surgery
Mean number of medication reduction from baseline to three years	Mean number of medications the patient has been able to stop taking since baseline	From baseline to three years post-surgery
Percentage of eyes with greater than twenty percent reduction in IOP from baseline to year three		From baseline to three years post-surgery
Percentage of eyes that are medication free at three years	Percentage of eyes that do not need any IOP lowering medication at three years	At three years post-surgery
Percentage of eyes with IOP between 14 and 18 mmHg on the same number of medications or fewer at three years post-surgery		At three years post-surgery
Change in average RNFL from baseline yearly to three years	Change from baseline yearly to three years in average optical coherence tomography retina nerve fiber layer measurements. OCT RNFL analysis is a non-invasive imaging technique that measures the thickness of the RNFL to help diagnose and monitor glaucoma.	At baseline, one year, two years and three years post-surgery
Change in average HVF PSD from baseline yearly to three years	Change from baseline yearly to three years in visual field pattern standard deviation. VF PSD is a metric that measures the irregularity of visual field loss.	At baseline, one year, two years and three years post-surgery
Percentage of eyes requiring secondary surgical intervention at yearly time points		At one year, two years and three years post-surgery

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Craig Chaya, MD, University of Utah John A. Moran Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): November 4, 2026

Study Registration Dates

• First Submitted: June 20, 2025
• First Submitted That Met QC Criteria: July 16, 2025
• First Posted (Actual): July 20, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 186645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No