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Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

NCT07073937 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-09

No results posted yet for this study

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

Interventions

OTHER

Retrospective chart review

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

Sponsors & Collaborators

Principal Investigators

  • Craig Chaya, MD · University of Utah John A. Moran Eye Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-09-17
Completion
2026-11-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073937 on ClinicalTrials.gov