Clinical Data for iStent inject®
Micro Stents. Macro Efficacy.
iStent inject® has been proven safe and effective in the eyes of patients in the US and around the world. And it has demonstrated efficacy across a wide range of clinical studies.
US Pivotal Trial1
In the US IDE Trial (n=505 subjects), iStent inject® met all study endpoints and demonstrated a clinically significant reduction in IOP for iStent inject® subjects at 24 months.
- 75.8% of iStent inject subjects had ≥ 20% reduction in unmedicated DIOP
- 7.0 mm Hg reduction from baseline in unmedicated DIOP
Other Observed Data:
- 17.1 mm Hg mean medication-free IOP at 24 months
- 63.2% medication-free DIOP ≤ 18 mm Hg at 24 months
- Mean of 0.4 medications at 23 months, down from preoperative mean of 1.6 for the treatment arm
Independent Clinical Study Results – 3-year Data2
Additional independent, long-term studies suggest that results are maintained several years after the procedure.
Long-term IOP Reduction
In a consecutive case series with three-year follow-up, mean IOP was 14.3 ± 1.7 mm Hg, representing a 37% reduction from preoperative medicated mean IOP of 22.6 ± 6.2 mm Hg, and 100% of eyes had an IOP ≤ 18 mm Hg.
Sustained Medication Reduction
In the same consecutive case series, mean medication use was decreased from 2.5 to 0.8 medications at three years, a 68% reduction. And 74% of eyes were using 0 or 1 medication as compared to 21% preoperatively.
Safety of iStent inject®
In the US IDE pivotal study, iStent inject® had no reports of hypotony, significant hyphema, flat anterior chamber, choroidal hemorrhage or effusion, or myopic shift.1
Medication reduction is subject to the discretion of the physician.
- iStent inject® Trabecular Micro-Bypass System: Directions for Use, Part # 45-0176.
- Hengerer FH. Personal Experience with Second-Generation Trabecular Micro-Bypass Stents in Combination with Cataract Surgery in Patients with Glaucoma: 3-Year Follow-up. ASCRS 2018 Presentation.
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