Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Nova Eye, Inc. · with Nova Eye Medical GmbH · NCT05564091
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 55+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 78
- US sites recruiting
- 1
- Study start
- September 8, 2022
- Record last updated
- April 18, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device; Cataract surgery
Conditions: Primary Open Angle Glaucoma
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Berkeley Eye Center
Sugar Land, TX 77478
Site contact: Morgan Micheletti, MD
Study contacts (from the official record)
- Mike Pickrel · 800-391-2316 · MPickrel@Nova-Eye.com