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.

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

Age range: 55+ years
Sex: All
Healthy volunteers: No

Detailed 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. *…

Interventions

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
University of Bonn Eye Clinic
Bonn
Augencentrum Köln Ophthalmology
Cologne
nkoerber@gmx.de
St. Johannes Hospital
Dortmund

Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Summary

Eligibility

Interventions

Locations (4)

Run this study?

Details

Conditions