Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

Study Overview
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Brief Summary
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A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).

Official Title
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Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro
* Device: Canaloplasty using the Omni surgical system with Healon GV Pro
* Device: Canaloplasty using the iTrack microcatheter with Healon Pro
* Device: Canaloplasty using the Omni surgical system with Healon Pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with mild to moderate open angle Glaucoma. Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB IOP < or = to 36 mmHG while on one to four ocular hypotensive medications Shaffer grade of > or = III in all four quadrants Able and willing to comply with the Protocol and follow up visits for 12 months Exclusion Criteria: Laser trabeculoplasty other than selective laser trabeculoplasty (SLT) History of iStent or iStent inject within 180 days of the screening visit History of ECP or Micropulse laser Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves Prior canaloplasty (ab interno and ab externo) Prior goniotomy or trabeculotomy History of Hydrus microstent or suprachoroidal stent History of cataract surgery within 6 months of screening Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iTrack canaloplasty microcatheter with Healon GV Pro<br>Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device) | Device: Canaloplasty using the iTrack microcatheter with Healon GV Pro<br>* 360 degree microcatheterization and viscodilation of Schlemm's canal<br>|
| Active Comparator: OMNI surgical system with Healon GV Pro<br>Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device) | Device: Canaloplasty using the Omni surgical system with Healon GV Pro<br>* 360 degree microcatheterization and viscodilation of Schlemm's canal<br>|
| Active Comparator: iTrack canaloplasty microcatheter with Healon Pro<br>Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device) | Device: Canaloplasty using the iTrack microcatheter with Healon Pro<br>* 360 degree microcatheterization and viscodilation of Schlemm's canal<br>|
| Active Comparator: OMNI surgical system with Healon Pro<br>Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device) | Device: Canaloplasty using the Omni surgical system with Healon Pro<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 |
| --- | --- | --- |
| Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention | IOP will be measured at each study visit using Goldmann applanation tonometry | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system. |  | 12 months | 
| Visual acuity at 12 months compared to baseline visual acuity | Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart | 12 months | 

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