Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

NCT07073937 | Enrolling By Invitation FDA Device

• 1 other identifier: 186645
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

  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

Study Arms (1)

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

Interventions

Retrospective chart review OTHER

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

Glaucoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Alcon Research: collaborator

Study Sites (1)

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Craig Chaya, MD

  University of Utah John A. Moran Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical)

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 20, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): November 4, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)