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Enrolling by Invitation

NCT Number: NCT07073937

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.

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Key information

Conditions

Glaucoma, Open Angle Canaloplasty Cataract Surgery Eye Diseases Glaucoma Glaucoma, Open-Angle Intraocular Pressure (IOP) MIGS Minimally Invasive Glaucoma Surgery Minimally Invasive Surgical Technique Ocular Hypertension Surgical Technique

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective Chart Review

Other

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

Primary outcomes

  1. Percentage of surgical success at three years.

    Time frame: From baseline to three years post-surgery

    Surgical success is defined as a decrease of one or more glaucoma medications from baseline without an increase in medicated intraocular pressure (IOP).

Secondary outcomes

  1. Mean decrease in IOP from baseline at three years

    Time frame: From baseline to three years post-surgery

  2. Mean number of medication reduction from baseline to three years

    Time frame: From baseline to three years post-surgery

    Mean number of medications the patient has been able to stop taking since baseline

  3. Percentage of eyes with greater than twenty percent reduction in IOP from baseline to year three

    Time frame: From baseline to three years post-surgery

  4. Percentage of eyes that are medication free at three years

    Time frame: At three years post-surgery

    Percentage of eyes that do not need any IOP lowering medication at three years

  5. Percentage of eyes with IOP between 14 and 18 mmHg on the same number of medications or fewer at three years post-surgery

    Time frame: At three years post-surgery

  6. Change in average RNFL from baseline yearly to three years

    Time frame: At baseline, one year, two years and three years post-surgery

    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.

  7. Change in average HVF PSD from baseline yearly to three years

    Time frame: At baseline, one year, two years and three years post-surgery

    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.

  8. Percentage of eyes requiring secondary surgical intervention at yearly time points

    Time frame: At one year, two years and three years post-surgery

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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