Long-Term Evidence With iStent^® inject

In 2016, the University of Heidelberg embarked on a long-term, real-world study of the iStent inject^® (Glaukos) as both a standalone procedure and combined with cataract surgery.¹Now, 7 years later, our data highlights more than just the success of the procedure—it confirms that the outcomes can have a profound impact on the quality of life of our patients.

REAL-WORLD OUTCOMES DATA

A total of 125 patients were enrolled. A combined procedure was performed in 81 eyes, and a standalone iStent inject procedure was performed in 44 eyes. IOP before surgery was slightly lower in the combined group, but these patients had undergone prior glaucoma surgery and were on multiple medications to manage their condition.

After 7 years, IOP decreased to 14 mm Hg, the mean IOP decreased by about 9 mm Hg, and patients had sustained a 59% reduction in medications (Figure), demonstrating the sustained efficacy of the iStent inject technology. There were no intraoperative or early postoperative complications, including anterior synechiae, a dislocated stent, hypotony, or choroidal hemorrhage. Seven eyes, two from the combined surgery group and five from the standalone iStent inject group, underwent a nonfiltering glaucoma procedure due to disease progression unrelated to stent implantation. No filtering surgery was required over the 7-year follow-up.

Our study found that even higher IOP values can be managed effectively with the iStent inject. Additionally, the procedure can mitigate the need for future, more invasive procedures. These findings underscore the importance of early intervention and point to the promise of sustained reduction of IOP and medication use for our patients’ quality of life.

CONCLUSION

Whether combined with cataract surgery or as a standalone procedure, the iStent inject^® W challenges the traditional norms in glaucoma management. Our 7-year journey with the iStent inject at the University of Heidelberg reinforces the importance of both patient selection and early intervention. Future advancements, such as the iStent infinite technology, offer hope for addressing more advanced glaucoma in a single session.

INDICATION FOR USE: The iStent inject^® 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 stent open a passage through the trabecular meshwork to allow for an increase in the 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: The iStent inject^® W System is contraindicated under the following circumstances or conditions: • In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations. • 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/PRECAUTIONS: • For prescription use only. • This device has not been studied in patients with uveitic glaucoma. • Do not use the device if the Tyvek^® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised. • Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container. • iStent inject^® W is MR-Conditional; see MRI Information below. • Physician training is required prior to use of the iStent inject^® W System. • Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.” • There are no known compatibility issues with the iStent inject^® W and other intraoperative devices. (e.g., viscoelastics) or glaucoma medications. • Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must be disposed of as medical waste. • The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure. • Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract. ADVERSE EVENTS: Please refer to Directions For Use for additional adverse event information. CAUTION: Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.

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