iSTENT INJECT® Treatment for Glaucoma during Cataract Surgery
by Carolyn B. Hebson, MD
VisionFirst Eye Center is proud to offer the iStent inject® which is FDA approved for the treatment of mild to moderate glaucoma in conjunction with cataract surgery. The iStent inject® is next-generation technology and an improvement of the original iStent which has been successfully implanted in over 400,000 eyes worldwide since 2012.
FDA approval of the iStent inject® was based on the U.S. IDE pivotal study which included 41 investigational sites and 505 mild to moderate glaucoma eyes which were randomized to receive iStent inject® in combination with cataract surgery or cataract surgery alone. This study showed that 75.8% of eyes that received the iStent inject® at the time of cataract surgery achieved a mean unmedicated reduction of intraocular pressure (IOP) of 7.0 mmHg. In addition, the safety profile of the iStent inject® was excellent with the overall rate of adverse events similar to cataract surgery alone1.
iStent inject® includes two heparin-coated titanium stents with each stent measuring approximately 0.23 mm x 0.36 mm [Figure 1]. The stents are preloaded into an auto-injection system that allows the surgeon to precisely implant the stents into the drainage system of the eye [Figure 2], which is often impaired in patients with glaucoma. The company that developed iStent inject® believes it is the smallest medical device ever approved by the FDA.
Glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing intraocular pressure is the only proven treatment. Based on analysis of population-based surveys, medical claims data and other statistics, it is estimated that there are approximately 5.4 million people in the U.S. with primary open angle glaucoma, the most common form of the disease.
Glaucoma is often treated with prescription eye drops, but the drops can be expensive, can cause redness and ocular irritation, and have to be consistently used one to three times per day for the effective treatment of glaucoma. Studies have shown that it is difficult for patients to consistently use even one glaucoma drop daily, and roughly 50% of patients discontinue glaucoma therapy after only a few months of treatment.
Performed at the time of cataract surgery, iStent inject® has proven to be effective in decreasing intraocular pressure (IOP) with an excellent safety profile, few complications, and fast recovery time. The majority of patients who received iStent inject® in the U.S. pivotal trial were medication-free at 23 months3, 4.
Do you have cataracts and take eye drops for the treatment of glaucoma? iStent inject® may be the treatment you have been waiting for. Contact VisionFirst Eye Center at (205) 949-2020 or www.visionfirsteyecenter.com to schedule a consultation today.
Market Scope, 2017 Glaucoma Surgical Device Report
Olthoff CM, Schouten JS, van de Borne BW, et al. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension: an evidence-based review. Ophthalmology 2005; 112:953-61
iStent inject® Trabecular Micro-Bypass System: Directions for Use, Part # 45-0176.
Saheb H, Ahmed I. Micro-Invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012; 23:96-104.