NCT07073937Enrolling by invitation
Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 20 Jun 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 17 Sept 2026
- Lead sponsor
- University of Utah
- Diseases
- Glaucoma
- NCT number
- NCT07073937
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Aug 2025 to the primary completion date, 17 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Angle closure glaucoma and other secondary glaucoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Utah John A. Moran Eye Center Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.