RECRUITING

A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma

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

This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.

Official Title

An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma

Quick Facts

Study Start:2024-08-14
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06615661

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:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary open angle glaucoma
  2. * Goniotomy surgery performed using the C-Rex Instrument
  1. * History of intraocular surgery within 8 weeks prior to C-Rex surgery
  2. * Preoperative IOP higher than 33 mmHg
  3. * Presence of a glaucoma type other than POAG
  4. * Presence of clinically significant intraocular pathology other than cataract or glaucoma

Contacts and Locations

Study Locations (Sites)

CIRCLE Site 04
Crossville, Tennessee, 38555
United States

Collaborators and Investigators

Sponsor: Iantrek, Inc.

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 Date2024-08-14
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-08-14
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Ocular Hypertension
  • Eye Diseases
  • Glaucoma
  • Goniotomy

Additional Relevant MeSH Terms

  • Primary Open Angle Glaucoma (POAG)