Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty deviceCataract surgery
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device: 360 degree microcatheterization and viscodilation of Schlemm's canal
Cataract surgery: Cataract surgery alone
Study summary
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 24 months.
Eligibility
Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
No
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)
* Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
* Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
* 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
Primary outcome measure(s)
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline — 12 months IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in number of glaucoma medications at 12 months compared to baseline — 12 months The number of glaucoma medications will be recorded at 12 months compared to baseline
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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