Search / Trial NCT06615661

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

Launched by IANTREK, INC. · Sep 24, 2024

Trial Information

Current as of October 04, 2024

Recruiting

Keywords

Ocular Hypertension, Eye Diseases, Glaucoma, Goniotomy

Description

This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed. Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively. Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Primary open angle glaucoma
  • * Goniotomy surgery performed using the C-Rex Instrument
  • Exclusion Criteria:
  • * History of intraocular surgery within 8 weeks prior to C-Rex surgery
  • * Preoperative IOP higher than 33 mmHg
  • * Presence of a glaucoma type other than POAG
  • * Presence of clinically significant intraocular pathology other than cataract or glaucoma

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Crossville, Tennessee, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0