๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
๐
What it tests
- Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
- Cataract surgery
Berkeley Eye Center
Sugar Land, United States
University of Bonn Eye Clinic
Bonn, Germany
Augencentrum Kรถln Ophthalmology
Cologne, Germany
St. Johannes Hospital
Dortmund, Germany
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.