RECRUITING

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

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Conditions

Primary Open Angle GlaucomaCanaloplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-09-08
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05564091

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.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mild to moderate, primary open angle glaucoma
  2. * Characteristics consistent with mild to moderate glaucoma
  3. * Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
  4. * Visually significant cataract
  1. * Laser Trabeculoplasty
  2. * Endocyclophotocoagulation (ECP) or Micropulse laser
  3. * iStent or iStent Inject
  4. * Hydrus Microstent
  5. * Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
  6. * Prior canaloplasty (ab-interno and ab-externo)
  7. * Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
  8. * Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
  9. * Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
  10. * Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
  11. * Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma

Contacts and Locations

Study Contact

Mike Pickrel
CONTACT
800-391-2316
MPickrel@Nova-Eye.com

Principal Investigator

Norbert Koerber, MD
PRINCIPAL_INVESTIGATOR
Augencentrum Köln Ophthalmology

Study Locations (Sites)

Berkeley Eye Center
Sugar Land, Texas, 77478
United States

Collaborators and Investigators

Sponsor: Nova Eye, Inc.

  • Norbert Koerber, MD, PRINCIPAL_INVESTIGATOR, Augencentrum Köln Ophthalmology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-08
Study Completion Date2027-07

Study Record Updates

Study Start Date2022-09-08
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Canaloplasty

Additional Relevant MeSH Terms

  • Primary Open Angle Glaucoma