Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07073937
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Jan 2026
Primary completion
Sep 17, 2026
Completion
Nov 4, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Percentage of surgical success at three years. [ Time Frame: From baseline to three years post-surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah John A. Moran Eye CenterSalt Lake CityUtah84132-

Find similar trials in Salt Lake City, UT

By condition
Glaucoma
By specialty
Ophthalmology
By research site
University of Utah John A. Moran Eye Center· Salt Lake City, UT

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