In an expanding field of micro-invasive glaucoma surgery (MIGS), surgeons can rely on Glaukos trabecular micro-bypass technology to safely and consistently deliver positive outcomes for their patients. iStent, implanted worldwide and backed by years of evidence from clinical studies,^1,2 was the first FDA-approved MIGS device that helped to revolutionize the surgical management of glaucoma. iStent inject^®, the second-generation trabecular micro-bypass device from Glaukos, received FDA approval in 2018 and has quickly set a new standard of care in MIGS.

iStent inject, which includes two tiny implants preloaded in a single-use injector, creates two patent bypass pathways through the trabecular meshwork into Schlemm’s canal to facilitate aqueous outflow, thereby decreasing intraocular pressure (IOP). Each stent is precisely designed to be no larger than necessary to carry the eye’s natural production of aqueous humor (2.5 ml/min),³ and has multiple outlets that allow for multidirectional flow through the canal. This not only helps restore natural physiologic out­flow, it also minimizes unnecessary disruption to the surrounding tissue and outflow system.

Multiple studies have demonstrated the ability for iStent inject, when placed 2 to 3 clock hours apart, to increase collector channel access by creating arcs of flow spanning 5 to 6 clock hours. In addition, in vivo aqueous angiography studies have shown iStent inject to create immediate and more expansive outflow facility,⁴ and the potential to re-establish flow in previously dormant outflow channels.⁵

In the 41-site clinical trial that led to the iStent inject’s 2018 FDA approval, more than 500 patients with mild-to-moderate primary open-angle glaucoma were randomized to stent implantation in combination with cataract surgery or cataract surgery alone. Patients receiving iStent inject achieved a statistically significant reduction in unmedicated diurnal IOP with an unparalleled level of safety.³ At 24 months, iStent inject achieved all clinical study endpoints. Additionally, 100+ peer-reviewed publications have demonstrated the safety and efficacy of Glaukos trabecular micro-bypass technologies.

The Truly Microinvasive Option

iStent inject is the smallest medical device known to be implanted in the human body. With diameters of 230 µm and heights of 360 µm, its two stents are minimally disruptive to surrounding tissue. Together, they occupy less than 0.5 mm of Schlemm’s canal. Both first- and second-generation Glaukos stents are manufactured from implant-grade titanium material and have been implanted in over 600,000 eyes, proving to be highly biocompatible for 10+ years and counting.

Efficacious, Safe, and Surgeon-Friendly

The iStent inject system was designed with both the surgeon and the patient in mind. The stents are preloaded into the injector, which is used for a straightforward click-and-release implantation through the main cataract incision. No additional incision is required.

Joshua W. Kim, MD, considers MIGS at the time of cataract surgery to be the standard of care for patients with mild-to-moderate open-angle glaucoma.

“Based on my experience, iStent inject is very safe, posing no more risk to patients than cataract surgery alone,” he says. “I find iStent inject to be more straightforward to use than other MIGS devices, and we’re placing two stents, which increases the likelihood of reaching a collector channel compared with one single stent.”

In addition to the iStent inject pivotal trial,³ an increasing number of clinical studies supports that the device provides significant and sustained IOP control and long-term safety.^6-8

According to Blake Williamson, MD, MPH, MS: “iStent inject is a fantastic MIGS device for compre-hensive surgeons, refractive cataract surgeons, surgeons just adopting MIGS, and seasoned MIGS veterans. Having two stents in Schlemm’s canal give us two chances to connect with a collector channel, the ‘super highways’ of outflow. This gives patients a better chance to reduce their medication burden and their vision is still great after cataract surgery. Postoperative management is similar to cataract surgery alone, and when to evaluate how patients fare with glaucoma medications discontinued can be based on surgeon preference.”

Drs. Kim, Williamson, and other U.S. surgeons have been tracking their initial results with iStent inject, which are compiled in this report.

REFERENCES

1. Craven ER, et al.; iStent Study Group. J Cataract Refract Surg. 2012;38(8):1339-1345;
2. Neuhann TH, et al. J Cataract Refract Surg. 2019;45(3):312-320;
3. Samuelson TW, et al. Ophthalmology. 2019;126:811-821;
4. Huang AS, et al. Ophthalmology Glaucoma. 2019;2(1):11-21;
5. Huang AS, et al. Invest Ophthalmol Vis Sci. 2016;57(11):4558-4565;
6. Clement CI, et al. Clin Ophthalmol. 2019;13:491-499;
7. Hengerer FH. Presented at the 2018 annual meeting of the American Society of Cataract and Refractive Surgery. Washington, D.C.;
8. Arriola-Villalobos P, et al. J Ophthalmology. 2016;2016:1056573;
9. Gazzard G, et al. Lancet. 2019;393(10180):1505-1516.