Clinical Data

iStent inject® W Clinical Data

Trabecular micro-bypass technology developed by Glaukos has been studied extensively around the world and its efficacy has been demonstrated in more than over 200 peer-reviewed articles, 20 years of clinical use, and over one million eyes.

The implantation of two trabecular bypass stents – without the benefit of cataract surgery – has been shown in prospective clinical trials to both lower IOP to <15 mm Hg and reduce medication burden via a unique two stent approach:

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
Study (duration) Guedes1 (12M) # of Subjects (at endpoint) 23 Post-Op Mean IOP (mmHG) 13.1 % IOP Reduction 19.1% % Medication Reduction 94.1%
Study (duration) Clement2 (12M) # of Subjects (at endpoint) 165 Post-Op Mean IOP (mmHG) 14.0 % IOP Reduction 23.2% % Medication Reduction 71.5%
Study (duration) Manning3 (12M) # of Subjects (at endpoint) 70 Post-Op Mean IOP (mmHG) 14.4 % IOP Reduction 29.4% % Medication Reduction 94.7%
Study (duration) Hengerer4 (84M) # of Subjects (at endpoint) 125 Post-Op Mean IOP (mmHG) 14.1 % IOP Reduction 40.0% % Medication Reduction 59.0%
Study (duration) Arriola-Villalobos5 (48M) # of Subjects (at endpoint) 20 Post-Op Mean IOP (mmHG) 16.25 % IOP Reduction 36.92% % Medication Reduction 42.3%

Can Reduce Intraocular Pressure (IOP) and
Medication Burden

iStent inject® W builds on the trabecular micro-bypass technology of iStent inject®, which has been proven effective in numerous studies in lowering IOP and reducing medication burden.

In one notable consecutive case study of iStent inject® involving multiple international surgeons, average medication usage was reduced from 1.0 to 0.1 at 12 months.6

Long-Term IOP Reduction5

Chart showing average medication usage was reduced from 1.0 to 0.1 at 12 months.

Another study conducted by multiple international surgeons demonstrated a mean IOP reduction of 47% vs. medicated screening at 18 months, finding that stents alone lowered IOP 5.1 mmHg from medicated screening.7

Line chart showing the mean IOP over time with a mean IOP reduction of 34% as compared to the medicated screening.

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.8

A bar graph showing sustained medication reduction: mean medication use was decreased from 2.5 to 0.8 medications at three years, a 68% reduction. Reduction key: dark green is 0 Med, green is 1 Med, dark blue is 2 Med, bright blue is 3 Med, blue is 4+ Med.

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.8

Medication reduction is subject to the discretion of the physician.

References

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Donnenfeld ED, Solomon KD, Voskanyan L, et al. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Opth. 2015;9:2057-2065.
  7. Samuelson TW. Outcomes of MIGS with Trabecular Micro-Bypass Stents and Prostaglandin in Open-Angle Glaucoma Subjects. Presented at the 2013 American Society of Cataract and Refractive Surgery Annual Meeting; April 19-23, 2013; San Francisco, California, USA.
  8. 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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iStent inject® W Important Safety Information

Indication For Use

The iStent inject® W (Model G2-W) is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject® W can deliver two (2) stents on a single pass, through a single incision. The implant is designed to open a passage through the trabecular meshwork allowing for increased facility of outflow and a subsequent reduction in intraocular pressure. The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.

Contraindications

In eyes with primary angle-closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucomas, in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

Warnings

This device has not been studied in patients with uveitic glaucoma. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. iStent inject® W is MR-Conditional meaning that the device is safe for use in a specified MRI environment under specified conditions; please see labeling for details. Physician training is required prior to use. Do not re-use the stent(s) or inserter.

Adverse Events

Postoperative adverse events include but are not limited to: early postoperative corneal edema, posterior capsule opacification, stent obstruction, intraocular inflammation (non-preexisting), BCVA loss, and IOP increase requiring management with oral or intravenous medications or surgical intervention. Please refer to Directions for Use for additional adverse event information.

Caution

Please reference Directions for Use labeling for a complete list of contraindications, warnings and adverse events

iStent inject® ISI