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

Description

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.

Conditions

Primary Open Angle Glaucoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Primary Open Angle Glaucoma
Intervention / Treatment

-

Contacts and Locations

Sugar Land

Berkeley Eye Center, Sugar Land, Texas, United States, 77478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nova Eye, Inc.,

Norbert Koerber, MD, PRINCIPAL_INVESTIGATOR, Augencentrum Köln Ophthalmology

Study Record Dates

2027-07