Glaucoma, Open AngleNCT07073937
Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty
An observational study of Glaucoma, Open Angle and MIGS, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open Angle, MIGS, Minimally Invasive Glaucoma Surgery
- What is being tested?
- Retrospective chart review
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 4 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, 84132
About this study
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
- Being tested
- Retrospective chart review
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective chart reviewOther
Retrospective study; a total of approximately 100 subjects have been identified to have had minimum 36 months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Retrospective chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to three years post-surgery
Secondary outcomes (8)
Mean decrease in IOP from baseline at three years
Measured: From baseline to three years post-surgery
Mean number of medication reduction from baseline to three years
Mean number of medications the patient has been able to stop taking since baseline
Measured: From baseline to three years post-surgery
Percentage of eyes with greater than twenty percent reduction in IOP from baseline to year three
Measured: From baseline to three years post-surgery
Percentage of eyes that are medication free at three years
Percentage of eyes that do not need any IOP lowering medication at three years
Measured: 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
Measured: At three years post-surgery
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.
Measured: At baseline, one year, two years and three years post-surgery
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.
Measured: At baseline, one year, two years and three years post-surgery
Percentage of eyes requiring secondary surgical intervention at yearly time points
Measured: At one year, two years and three years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Aug 2025
- Primary completion17 Sep 2026 (estimated)
- Study completion4 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Craig Chaya, University of Utah
- Investigators
- Craig Chaya, MD, Principal investigator, University of Utah John A. Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073937
- Sponsor's protocol ID
- 186645
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No