Trials / Enrolling By Invitation
Enrolling By InvitationNCT07073937
Three Year Outcomes of Combined Hydrus Microstent With iTrack Canaloplasty
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- University of Utah · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Glaucoma, Open Angle
- MIGS
- Minimally Invasive Glaucoma Surgery
- Canaloplasty
- Intraocular Pressure (IOP)
- Cataract Surgery
- Surgical Technique
- Minimally Invasive Surgical Technique
- Glaucoma
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Retrospective chart review | Retrospective study; a total of approximately 100 subjects have been identified to have had minimum 36 months follow-up. |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2026-09-17
- Completion
- 2026-11-04
- First posted
- 2025-07-20
- Last updated
- 2026-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07073937. Inclusion in this directory is not an endorsement.