Clinical Data
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.
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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.
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Safety
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.
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