Clinical Data

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

A bar chart from the U.S. IDE trial shows that 75.8% of subjects in the iStent inject® treatment group (combined iStent inject® + Phaco) achieved an equal to or greater than 20% reduction of unmedicated DIOP at 24 months compared to 61.9% of subjects receiving Phaco alone.  A second chart from the same study shows that subjects in the iStent inject® treatment group achieved a 7.0 mm Hg reduction of mean unmedicated DIOP compared to subjects receiving Phaco alone who achieved a 5.4 mm Hg reduction.  Both the primary and secondary endpoints of the pivotal trial were met.
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

A circle data callout shows that 84% of iStent inject® subjects were medication-free at 23 months in the U.S. IDE trial.


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

A line chart from a 3-year consecutive case series shows 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.

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

A bar chart from a 3-year consecutive case series shows that 74% of eyes were using 0 or 1 medication as compared to 21% preoperatively.

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

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.

  1. iStent inject® Trabecular Micro-Bypass System: Directions for Use, Part # 45-0176.
  2. 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.

Important Safety Information »

Looking for more information on iStent inject®?

We’re here to answer questions and provide any additional information you may need.

Contact Us