RECRUITINGINTERVENTIONAL
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
360 degree microcatheterization and viscodilation of Schlemm's canal
PROCEDURE
Cataract surgery
Cataract surgery alone
Locations (4)
Berkeley Eye Center
Sugar Land, Texas, United States
University of Bonn Eye Clinic
Bonn, Germany
Augencentrum Köln Ophthalmology
Cologne, Germany
St. Johannes Hospital
Dortmund, Germany