Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
Berkeley Eye Center
RECRUITING
Sugar Land
Other Locations
Germany
University of Bonn Eye Clinic
RECRUITING
Bonn
Augencentrum Köln Ophthalmology
RECRUITING
Cologne
St. Johannes Hospital
RECRUITING
Dortmund
Contact Information
Primary
Mike Pickrel
MPickrel@Nova-Eye.com
800-391-2316
Time Frame
Start Date: 2022-09-08
Estimated Completion Date: 2027-07
Participants
Target number of participants: 78
Treatments
Active_comparator: Cataract surgery combined with ab-interno canaloplasty
Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)
Other: Control: Cataract surgery
Cataract surgery alone
Related Therapeutic Areas
Sponsors
Leads: Nova Eye, Inc.
Collaborators: Nova Eye Medical GmbH