ClinicalTrials.gg
Enrolling by invitationNCT07073937Updated Aug 26, 2026

Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty

An observational study in Glaucoma, Open Angle, MIGS and Minimally Invasive Glaucoma Surgery, sponsored by University of Utah. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by University of Utah · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
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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.

02

Conditions studied

  • Glaucoma, Open Angle
  • MIGS
  • Minimally Invasive Glaucoma Surgery
  • Canaloplasty
  • Intraocular Pressure (IOP)
  • Cataract Surgery
  • Surgical Technique
  • Minimally Invasive Surgical Technique
  • Glaucoma
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 100 is close to the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherRetrospective chart review

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

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What researchers measure

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).

    Time frame: From baseline to three years post-surgery

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

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

    Time frame: From baseline to three years post-surgery

  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

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

    Time frame: At three years post-surgery

  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

    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.

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

  7. 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.

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

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

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

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Sep 2026, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2025
First posted
Jul 20, 2025
StartActual
Aug 1, 2025
Primary completionEst.
Sep 17, 2026
CompletionEst.
Nov 4, 2026
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07073937
Lead sponsor
University of Utah
Collaborators
Alcon Research
Responsible party
Craig Chaya (Assistant Professor (Clinical), University of Utah) — Principal investigator
First posted
Jul 20, 2025
Start date
Aug 1, 2025
Primary completion
Sep 17, 2026 (estimated)
Completion
Nov 4, 2026 (estimated)
Last update
Aug 26, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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