A prospective, randomized, multi-center evaluation of the Safety and Effectiveness of the STREAMLINE®SURGICAL SYSTEM compared to iStent Inject W® in Patients with Open-Angle Glaucoma
Primary Objective
The purpose of this research study is to compare the safety and IOP-lowering effectiveness of the STREAMLINE® SURGICAL SYSTEM to the iStent Inject W® in patients with mild to moderate, open-angle glaucoma who have undergone uncomplicated cataract surgery.
Description
The STREAMLINE® Surgical System consists of a surgical grade stainless steel disposable cannula (hollow tube) and a manual handset. The stainless steel cannula (hollow tube) is placed along the drainage duct of the eye (also called the trabecular meshwork) and a button is pressed that activates the stainless steel tip, which punctures the trabecular meshwork and delivers an application of viscoelastic material to Schlemm’s canal. Your study doctor will deliver multiple applications of viscoelastic material. The iStent Inject W® is a titanium stent (drainage device) that is inserted into the drainage duct of the eye (the trabecular meshwork) by using a handheld device. A micro-insertion tube is placed into the trabecular meshwork and a button is pressed that implants the stent. Your study doctor may implant more than one stent in your eye.
Details
Locations
University of Colorado Hospital
Principal Investigator
Leonard Seibold
Study ID
Protocol Number: 21-4696
More information available at ClinicalTrials.gov: NCT05280366
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