Enrollment in the investigational device exemption trial for the iStent Supra for treatment of patients with open-angle glaucoma and cataracts has been completed, Glaukos announced in a press release.
The prospective, randomized clinical trial includes 505 subjects across 36 sites. Patients will receive either the iStent Supra with cataract surgery or cataract surgery alone. The study aims for at least a 20% reduction in IOP from baseline in 24 months.
“We expect the iStent Supra to ultimately be an important part of ophthalmic surgeons’ armamentarium for effectively managing IOP,” Glaukos president and CEO Thomas Burns said in the release.
The approximately 4-mm long, curved iStent Supra addresses aqueous fluid outflow via the suprachoroidal space rather than more traditional access via the trabecular meshwork.