A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS Compared to iStent inject W in Patients with Open-Angle Glaucoma Undergoing Cataract Surgery - ELIOS-RCT

ELIOS Vision Inc0 sites14 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

ELIOS Vision Inc

•Patients are eligible for inclusion in this clinical trial if all the following
•criteria apply. Ocular criteria pertain to the study eye only.
•1\. Male or female subjects;
•2\. 40 years old or older;
•3\. Diagnosis of mild to moderate primary open\-angle glaucoma, pseudoexfoliation
•glaucoma or pigmentary glaucoma
•a. Glaucomatous optic nerve damage as evidenced by any of the following optic
•disc or retinal nerve fiber layer structural abnormalities:
•i. Diffuse thinning, focal narrowing or notching of the optic disc rim,
•especially at the inferior or superior poles with or without disc hemorrhage;

•A subject who meets any of the criteria listed below will be excluded from the
•study. Ocular criteria pertain to the study eye only unless otherwise
•1\. All forms of angle closure glaucoma;
•2\. Secondary glaucoma, including traumatic, neovascular, uveitic, lens\-induced,
•steroid\-induced, angle\-recession, glaucoma associated with vascular disorders,
•and glaucoma associated with increased episcleral venous pressure;
•3\. Congenital or developmental glaucoma;
•4\. Prior incisional glaucoma surgery, intraocular surgery or ocular laser
•treatment of any type (e.g., argon laser trabeculoplasty \[ALT], non\-laser
•retinal surgery, cyclodestructive procedure, scleral buckling procedure,