Multicenter Glaucoma Study Investigating Standalone Canaloplasty

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: Ab-interno canaloplasty utilizing the iTrack Advance device
* Device: Ab-interno canaloplasty utilizing the OMNI Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy Intolerance to medical therapy OR need/willingness to reduce medications At the Screening Visit, IOP of ≤ 30 mmHg while on 1-4 ocular hypotensive medications At the Baseline Visit, unmedicated IOP ≥ 21mmHg and ≤ 33 mmHg, and ≥ 3mmHg higher than medicated IOP Shaffer grade of ≥ 3 in all four quadrants Endothelial cell density >2000 (cells/mm2) Central corneal thickness ≥ 490µm and ≤ 600 µm Able and willing to comply with the study procedures and attend all follow-up visits Understands and signs the informed consent Exclusion Criteria: Any of the following prior treatments for glaucoma (study eye): Laser trabeculoplasty i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty iStent or iStent Inject within 180 days of the Screening Visit Endocyclophotocoagulation (ECP) or Micropulse laser Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve Prior canaloplasty (ab interno and ab externo) Prior goniotomy, or trabeculotomy (ab externo and ab interno) Hydrus microstent Suprachoroidal stent (e.g., Cypass, iStent Supra) Concurrent IOP-lowering procedure other than use of the iTrack Advance canaloplasty device OR the OMNI Surgical System at the time of surgery (e.g., ECP, CPC, etc.) Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudoexfoliative glaucoma Cataract surgery within 6 months of the Screening Visit in the study eye History of fellow eye with cataract surgery within 30 days of Screening Subjects at significant risk by a washout of ocular hypotensive medication, and/or subjects where the unmedicated IOP is expected to exceed the upper limit of 33 mmHg Use of systemic medications (either current, within 30 calendar days of Screening exam, or anticipated) that may cause an increase in IOP, (e.g., systemic steroids including inhaled and oral steroids used on a regular basis) Ocular and/or systemic diseases that could affect the corneal endothelium (such as corneal endothelial dystrophy, intraocular inflammation and infection, or congenital abnormalities) History of penetrating keratoplasty or another corneal transplant BCVA of 20/200 or worse in the fellow eye not due to cataract Previous treatment with OMNI or iTrack (Note: permitted if fellow eye only was treated) BCVA of 20/50 or worse in the study eye not due to posterior capsular opacification

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iTrack Advance<br>Ab-interno canaloplasty utilizing the iTrack Advance microcatheter device (Nova Eye, Inc.) | Device: Ab-interno canaloplasty utilizing the iTrack Advance device<br>* 360 degree microcatheterization and viscodilation of Schlemm's canal<br>|
| Active Comparator: OMNI Surgical System<br>Ab-interno canaloplasty utilizing the OMNI Surgical System | Device: Ab-interno canaloplasty utilizing the OMNI Surgical System<br>* 360 degree microcatheterization and viscodilation of Schlemm's canal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in unmedicated Intraocular pressure (IOP) at 12 months post-intervention compared to baseline |  | 12 months | 
| Percentage of eyes achieving a 20% or greater reduction in unmedicated Intraocular pressure (IOP) at 12 months compared to baseline and without any other intervention (medication or secondary surgery) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Canaloplasty