iStent® Clinical Data
Recent randomized controlled trials and case studies have shown that iStent® is a procedure with limited complications and an excellent safety profile. A recent independent international clinical study, published by the Journal of Cataract and Refractive Surgery, shows that iStent® provided a 36% reduction in IOP and an 86% reduction in the number of glaucoma medications three years following surgery.
Reduced Intraocular Pressure (IOP)
The U.S. IDE pivotal study for iStent® conducted by Glaukos and reviewed by the FDA was the first prospective, randomized U.S. IDE trial for a glaucoma device. This groundbreaking study showed that 68% of subjects in the iStent® treatment group (combined cataract and iStent® implantation) met the primary endpoint of IOP ≤ 21 mm Hg with no medications at 12 months, compared to only 50% of subjects in the cataract surgery group only. This difference is statistically (p = .004) and clinically significant.
In a second, independent, 36-month study, 79% of patients who received iStent® during a cataract procedure sustained target IOPs of ≤ 21 mm Hg.
Reduction in Glaucoma Medication
The IDE pivotal trial additionally showed 64% of patients who received iStent® remained medication free while sustaining a mean IOP reduction of 20% versus only 47% who underwent cataract surgery alone (p = .010).
In the independent, 36-month study noted previously, 74% of patients who received iStent® during a cataract procedure were able to stop taking their glaucoma medication after surgery.
For patients with combined cataract and open-angle glaucoma, iStent® can reduce IOP, while maintaining an excellent safety profile. The U.S. IDE pivotal study showed:
|Adverse Events||Cataract Surgery with iStent®
N=116 n (%)
|Cataract Surgery Only
N=117 n (%)
|Early postop corneal edema||9 (8%)||11 (9%)|
|Any BCVA loss of at least 1 line at or after the 3 month visit||8 (7%)||12 (10%)|
|Posterior capsular opacification||7 (6%)||12 (10%)|
|Stent obstruction||5 (4%)||0 (0%)|
|Blurry vision or visual disturbance||4 (3%)||8 (7%)|
|Elevated IOP||4 (3%)||5 (4%)|
The iStent® procedure spares conjunctival tissue and preserves the potential for future treatment options. Additionally, there is minimal risk of hypotony with implantation of iStent® because the trabecular meshwork is preserved, ensuring a natural episcleral back-pressure of 8 to 11 mm Hg.
Looking for more information on iStent®?
We’re here to answer questions and provide any additional information you may need.Contact Us