Clinical Data
Clinical Data
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
Primary Endpoint
≥ 20% Reduction in Unmedicated DIOP
Secondary Endpoint
Mean Unmedicated DIOP Reduction
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.
| Study (duration) | # of Subjects (at endpoint) | Post-Op Mean IOP (mmHG) | % IOP Reduction | % Medication Reduction |
|---|---|---|---|---|
| Guedes2 (12M) | 23 | 13.1 | 19.1% | 94.1% |
| Clement3 (12M) | 165 | 14.0 | 23.2% | 71.5% |
| Manning4 (12M) | 70 | 14.4 | 29.4% | 94.7% |
| Hengerer5 (84M) | 125 | 14.1 | 40.0% | 59.0% |
| Arriola-Villalobos6 (48M) | 20 | 16.25 | 36.92% | 42.3% |
Long-Term IOP Reduction5
Sustained Medication Reduction5
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.
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.1,6
Medication reduction is subject to the discretion of the physician.
Request the iStent inject® W posters
presented at ARVO 2021
Five posters presented at ARVO 2021 highlight the efficacy and safety of the iStent platform as compared to other procedures.
References:
- 1. 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.
- 2. 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.
- 3. 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.
- 4. 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.
- 5. Hengerer FH, Auffarth G, Conrad-Hengerer I. Sustained 7-year glaucoma control after second-generation trabecular micro-bypass with or without cataract surgery. Abstract presented at: Annual Meeting of the American Society of Cataract and Refractive Surgery; May 5-8, 2023; San Diego, CA.
- 6. 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.