New Study Underscores Ability of iStent to Achieve Sustained Reductions in IOP and Medication Use

Source: Glaukos

Tuesday, September 27, 2016 | Glaucoma , Medical Studies , Glaukos Corporation , MIGS


A study published in Clinical Ophthalmology showed that a consistent cohort of 107 open-angle glaucoma (OAG) eyes receiving the iStent Trabecular Micro-Bypass Stent in combination with cataract surgery achieved a 22% reduction in mean IOP to 15.17 mm Hg and a 56% reduction in mean ocular hypotension medications to 0.61 2 years following surgery, according to Glaukos.

The retrospective, consecutive case series includes 350 eyes that underwent iStent implantation with concomitant cataract surgery between October 2012 and December 2015. Study researchers reported a favorable safety profile and postoperative follow-up of all eyes is ongoing. All procedures were performed by John P. Berdahl, MD, at a single site in Sioux Falls, South Dakota. The series represents Dr. Berdahl’s typical clinical use of the iStent. In this study, OAG subjects were defined as patients with primary OAG, normal tension glaucoma and ocular hypertension, with no cases excluded.

“Our data show that mild-to-moderate OAG patients receiving a single iStent with cataract surgery can achieve sustained IOP levels approaching 15 mm Hg and also reduce their dependence on glaucoma medications,” Dr. Berdahl said in a Glaukos news release. “These outcomes are important because controlling IOP is the only proven treatment for glaucoma and its management is often hindered by the poor compliance, cost and side effects associated with topical ocular hypotensive medications that patients must administer one or more times a day for the rest of their lives.”

Study researchers indicated that, to their knowledge, this study represents the largest sample size published to date regarding the iStent in combination with cataract surgery. The full Clinical Ophthalmology article is available online at https://www.dovepress.com/clinical-evaluation-of-a-trabecular-microbypass-stent-with-phacoemulsi-peer-reviewed-article-OPTH.

Typically associated with elevated IOP, glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. It is a leading cause of blindness. According to Market Scope, more than 80 million people worldwide have glaucoma, including 4.5 million people in the United States. Open-angle glaucoma is the most common form, affecting approximately 3.6 million people in the United States.

The iStent was approved by the FDA in June 2012 and is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication. The iStent is inserted through the trabecular meshwork and into Schlemm’s canal, the eye’s drainage system, where it restores the natural, physiological outflow of aqueous humor. Made of surgical-grade non-ferromagnetic titanium that is coated with heparin, the iStent is approximately 1.0 mm long and 0.33 mm wide. Glaukos believes it is the smallest medical device ever approved by the FDA.


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