Actively Recruiting
Multicenter Glaucoma Study Investigating Standalone Canaloplasty
Led by Nova Eye, Inc. · Updated on 2025-04-18
86
Participants Needed
5
Research Sites
186 weeks
Total Duration
On this page
Sponsors
N
Nova Eye, Inc.
Lead Sponsor
N
Nova Eye Medical GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.
CONDITIONS
Official Title
Multicenter Glaucoma Study Investigating Standalone Canaloplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects, 22 years or older at the time of surgery
- Diagnosed with mild to moderate primary open angle glaucoma
- Candidate for canaloplasty surgery including catheterization and viscodilation of Schlemm's canal without trabeculotomy
- Intolerance to medical therapy or willingness to reduce medications
- At screening, intraocular pressure (IOP) of 30 mmHg or less while on 1-4 glaucoma medications
- At baseline, unmedicated IOP between 21 and 36 mmHg and at least 3 mmHg higher than medicated IOP
- Shaffer grade of 3 or higher in all four eye quadrants
- Central corneal thickness between 480 µm and 620 µm
- Able and willing to comply with study procedures and attend all follow-up visits
- Understands and signs informed consent
You will not qualify if you...
- Prior glaucoma treatments in the study eye such as laser trabeculoplasty within 6 months, Argon laser trabeculoplasty, iStent or iStent Inject within 180 days, endocyclophotocoagulation, micropulse laser, trabeculectomy or bleb-forming procedures, prior canaloplasty, goniotomy or trabeculotomy, Hydrus microstent, suprachoroidal stents, or concurrent IOP-lowering procedures other than the study devices
- Acute angle closure, traumatic, congenital, malignant, uveitic, neovascular, pigmentary, or pseudoexfoliative glaucoma
- Cataract surgery within 6 months in the study eye or within 30 days in the fellow eye
- High risk for washout of ocular medications or expected unmedicated IOP over 36 mmHg
- Use of systemic medications that increase IOP such as regular systemic steroids
- Eye or systemic diseases affecting the corneal endothelium or history of corneal transplant
- Best corrected visual acuity of 20/200 or worse in the fellow eye (not due to cataract)
- Previous treatment with OMNI or iTrack in the study eye
- Best corrected visual acuity of 20/50 or worse in the study eye (not due to posterior capsular opacification)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Breyer Kaymak Klabe Augenchirurgie
Düsseldorf, Germany
Actively Recruiting
2
Hospital Clinico San Carlos, Servicio de Oftalmologia
Madrid, Spain
Actively Recruiting
3
Princess Alexandra Eye Pavilion, NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
4
St. Paul's Eye Unit, Liverpool University
Liverpool, United Kingdom
Actively Recruiting
5
Manchester Royal Eye Hospital
Manchester, United Kingdom
Actively Recruiting
Research Team
M
Mike Pickrel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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