Optimizing the sequence of surgical interventions is critical in glaucoma management to maximize patient safety and preserve long-term visual function. Initiating treatment with minimally invasive options like the iStent inject® W (Glaukos) aligns with a safety-first strategy, offering effective IOP control while maintaining future therapeutic flexibility (data on file with Glaukos).
THE ROLE OF ISTENT inject® W IN GLAUCOMA MANAGEMENT
The iStent inject® (Glaukos) has been shown to provide significant IOP reduction while maintaining an excellent safety profile.1 It has been demonstrated to be effective whether used as a standalone procedure or in combination with cataract surgery.2 Importantly, it offers consistent efficacy across varying levels of preoperative disease burden.3 With substantial improvements in quality of life reported,4 the iStent® technologies (Glaukos) are an appealing option for glaucoma specialists seeking to manage patients with mild to moderate disease while preserving future treatment options.
Additionally, iStent® technologies have been shown to slow the progression of visual field loss, a crucial goal in long-term glaucoma management.5 This makes it not only effective, but also a preventive intervention, offering benefits that go beyond immediate IOP reduction.
SAFETY PROFILE AND PROCEDURE EFFICIENCY
The iStent inject® overall safety profile is comparable to cataract surgery alone,1 making it a low-risk option for IOP management. The technology has a short learning curve, which allows for straightforward implantation and quick integration into clinical practice. Its minimally invasive design results in minimal disruption to the ocular anatomy—only occupying 2% of the trabecular meshwork and leaving 98% untouched—enabling faster recovery times and reducing the likelihood of complications (data on file with Glaukos).
Furthermore, the procedure does not preclude future interventions, maintaining flexibility for subsequent surgical or medical treatments (data on file with Glaukos). This is particularly valuable for patients who may require more aggressive treatments as their disease progresses.
A PROACTIVE APPROACH TO GLAUCOMA MANAGEMENT
The iStent® technology provides a robust, early-intervention strategy for glaucoma management. Its proven IOP-lowering efficacy,1 favorable safety profile,1 and long-term benefits6,7 make it a critical tool for preventing disease progression.5 By integrating this procedure early in the treatment sequence, clinicians can offer patients a proactive pathway that not only controls IOP but also preserves visual function and quality of life over the long term.5
1. Samuelson TW, Sarkisian SR Jr, Lubeck DM, et al. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract: two-year results. Ophthalmology. 2019;126(6):811-821.
2. Healey PR, Clement CI, Kerr NM, Tilden D, Aghajanian L. Standalone iStent trabecular micro-bypass glaucoma surgery: a systematic review and meta-analysis. J Glaucoma. 2021;30(7):606-620.
3. Singh IP, Sarkisian S, Hornbeak D, Katz LJ, Samuelson T; iStent inject Study Group. Treatment success across different levels of preoperative disease burden: stratified two-year outcomes from the pivotal trial of iStent inject trabecular micro-bypass in primary open-angle glaucoma and cataract. Clin Ophthalmol. 2021;15:3231-3240.
4. Samuelson TW, Singh IP, Williamson BK, et al. Quality of life in primary open-angle glaucoma and cataract: an analysis of VFQ-25 and OSDI from the iStent inject pivotal trial. Am J Ophthalmol. 2021;229:220-229.
5. Gillmann K, Hornbeak DM. Rates of visual field change and functional progression in glaucoma following trabecular microbypass implantation of iStent technologies: a meta-analysis. BMJ Open Ophthalmol. 2024;9(1).
6. Hengerer FH, Auffarth GU, Conrad-Hengerer I. 7-year efficacy and safety of iStent inject trabecular micro-bypass in combined and standalone usage. Adv Ther. 2024;41(4):1481-1495.
7. Neuhann TH, Neuhann RT, Hornbeak DM. Ten-year effectiveness and safety of trabecular micro-bypass stent implantation with cataract surgery in patients with glaucoma or ocular hypertension. Ophthalmol Ther. 2024;13(8):2243-2254.
INDICATIONS FOR USE: The iStent® Trabecular Micro-Bypass System is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma. 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® Trabecular Micro-Bypass Stent 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 devices if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised. iStent is MR-Conditional. Physician training by Glaukos personnel is required prior to use of this device. Do not re-use the stent(s) or inserter, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events. There are no known compatibility issues with the iStent 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 infected products must be disposed of as medical waste.
INDICATIONS FOR USE: The iStent inject® 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® 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® 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 devices 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® is MR-Conditional; see MRI Information below. • Physician training is required prior to use of the iStent inject® System. • Do not re-use the stent(s) or inserter, 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® 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. • Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body • 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.
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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