Clinical Data for iStent inject® W
Micro Stents. Macro Efficacy.
iStent inject® W builds on the trabecular micro-bypass technology of iStent inject®, which has demonstrated efficacy across a wide range of clinical studies.
US Pivotal Trial at 24 Months1
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
Additional independent, long-term studies of Glaukos trabecular micro-bypass technology suggest that results are maintained several years after the procedure.
Long-term IOP Reduction 5
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 IOP ≤ 18 mm Hg.
Sustained Medication Reduction5
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 compared to 21% preoperatively.
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.1,6
Medication reduction is subject to the discretion of the physician.
- Samuelson TW, Sarkisian SR, Lubeck DM, et al. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract. Ophthalmology. Jun 2019;126(6):811-821.
- Guedes RAP, Gravina DM, Lake JC, Guedes VMP, Chaoubah A. Intermediate results of iStent® or iStent inject® implantation combined with cataract surgery in a real-world setting: a longitudinal retrospective study. Ophthalmol Ther. March 2019;8(1):87-100.
- Clement CI, Howes F, Ioannidis AS, Shiu M, Manning D. One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study. Clin Ophthalmol. 2019:13;491-499.
- Manning D. Real-world case series of iStent® or iStent inject® trabecular micro-bypass stents combined with cataract surgery. Ophthalmology & Therapy. 2019. doi:https://doi.org/10.1007/s40123-019-00208-x.
- 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.
- Arriola-Villalobos P, Martinez-de-la-Casa JM, Diaz-Valle D, et al. Glaukos iStent inject® trabecular micro-bypass implantation associated with cataract surgery in patients with coexisting cataract and open-angle glaucoma or ocular hypertension: a long-term study. J Ophthalmology. 2016;1-7.
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