Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Study Overview
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Brief Summary
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A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 12 months.

Official Title
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Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate, primary open angle glaucoma Characteristics consistent with mild to moderate glaucoma Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria Visually significant cataract Exclusion Criteria: Any of the following prior treatments for glaucoma (study eye): Laser Trabeculoplasty Endocyclophotocoagulation (ECP) or Micropulse laser iStent or iStent Inject Hydrus Microstent Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve. Prior canaloplasty (ab-interno and ab-externo) Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN) Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.) Previous treatment with iTrack (Note: permitted if fellow eye only was treated) Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudo exfoliative glaucoma.

Ages Eligible for Study
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Minimum Age: 55 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: Cataract surgery combined with ab-interno canaloplasty<br>Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) | Device: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device<br>* 360 degree microcatheterization and viscodilation of Schlemm's canal<br>|
| Other: Control: Cataract surgery<br>Cataract surgery alone | Procedure: Cataract surgery<br>* Cataract surgery alone<br>* Other names: Phacoemulsification;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline | IOP will be measured at each study visit using Goldmann applanation tonometry | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the reduction in number of glaucoma medications at 12 months compared to baseline |  | 12 months | 

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