What this study is
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.
What's being tested
- Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device
Intervention · DEVICE
360 degree microcatheterization and viscodilation of Schlemm's canal
- Cataract surgery
Intervention · PROCEDURE
Cataract surgery alone
Study details
- Sponsor
- Nova Eye, Inc.
- Conditions
- Primary Open Angle Glaucoma
- Enrolling
- 78 people
- Starts
- 2022-09-08
- Est. completion
- 2027-07
- Design
- Single-blind, randomized, factorial
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openBerkeley Eye Center
Sugar Land, Texas, United States
- Morgan Micheletti, MD · Contact
Recruiting
3 sites outside the US
University of Bonn Eye Clinic
Bonn, Germany
- Karl Mercieca, MD · Contact
Recruiting- Recruiting
St. Johannes Hospital
Dortmund, Germany
- Markus Kohlhaas, MD · Contact
Recruiting
Study team
Sponsor
Nova Eye, Inc.
Study ID NE 03021
Principal investigator
Norbert Koerber, MD
Augencentrum Köln Ophthalmology
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.