Purpose of this Study
We are doing this study to evaluate the safety and effectiveness of a medical laser device called the ELIOS System® when it is used in a procedure to reduce intraocular pressure in people with mild-to-moderate primary open-angle glaucoma.
Who Can Participate?
Eligibility
Adults ages 45+ who:
- Are diagnosed with mild-to-moderate primary open-angle glaucoma
- Have never had any type of glaucoma surgery
Age Range
45-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will receive the laser procedure if you are found to be eligible.
Participation in this study will last approximately 12 months after the laser procedure. We will schedule you to come in for 9 follow-up visits to the study clinic. During these visits, you will have eye exams, vision tests, and have blood draws.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Prospective, Multicenter, Non-Randomized Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients with Primary Open-Angle Glaucoma as a Standalone Procedure - EP-02
Principal Investigator
Leon
Herndon
Protocol Number
PRO00117403
NCT ID
NCT05999006
Phase
N/A
Enrollment Status
Pending Open to Enrollment