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
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.
MoreAdult
- Be 22 years or older - Require cataract surgery - Have a diagnosis of mild to moderate open angle glaucoma in at least one eye - Be on 1-3 IOP-lowering medications at your screening visit - Have eye pressure between 22-34mmHg after being taken off your IOP lowering medication - Your study doctor believes your eyes meet the criteria and you have the potential for good visual acuity after your cataract surgery - Able to follow the requirements of the study and attend all visits.
Treatment
University of Colorado Hospital
Leonard Seibold, MD
Protocol Number: 21-4696
More information available at ClinicalTrials.gov: NCT05280366
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