For patients with primary open-angle glaucoma undergoing cataract surgery, the iStent® (Glaukos) technologies offer a promising and enduring solution to achieve effective IOP control with reduced reliance on medications.1 Ten-year data from a single-surgeon case series emphasizes the long-term safety and efficacy of the iStent® as an integrated approach in glaucoma management.1
STUDY DESIGN AND PATIENT CLASSIFICATION
The retrospective case series examined the outcomes of iStent® implantation combined with cataract surgery in 63 eyes over a follow-up period extending to 10 years (Figure 1). Patients were classified into three glaucoma burden categories based on their baseline IOP and medication requirements:
- Light burden (IOP ≤18 mm Hg on ≤1 medication [26%]);
- Medium burden (IOP >18 mm Hg or on ≥2 medications [44%]); and
- Heavy burden (IOP >18 mm Hg and on ≥2 medications [30%]).
Figure 1. Baseline characteristics and preoperative glaucoma burden.
This study included a broad range of patients, with eligibility extending to those with varied surgical histories and preoperative IOP levels. Angle-closure glaucoma and other conditions that could interfere with the procedure’s efficacy were excluded.
The cohort consisted predominantly of elderly patients (mean age of 81.6 years), and the majority were women (64%). Most patients (95.2%) received the iStent® alongside cataract surgery, while a smaller percentage (4.8%) underwent standalone iStent® implantation. The patient population included individuals with primary open-angle glaucoma (68%), pseudoexfoliative glaucoma (27%), and ocular hypertension (5%), with a baseline mean IOP of 18.6 mm Hg and an average medication load of 1.83 agents.
LONG-TERM OUTCOMES
Over the 10-year follow-up, patients experienced stable and significant reductions in both IOP and medication requirements (Figure 2). These findings confirm the durability of the iStent® for managing IOP and reducing medication burden, a key benefit for elderly patients who may face challenges with complex drug regimens.2
Figure 2. Long-term efficacy of iStent over 10 years.
Safety outcomes were positive throughout the 10-year period. Patients experienced improvements in corrected distance visual acuity, which were maintained over time. Importantly, there were no incidences of hypotony maculopathy, retinal detachment, endophthalmitis, or choroidal hemorrhage. Secondary glaucoma surgeries were rare and involved minimally invasive options, such as additional iStent® placements, rather than more invasive filtering surgeries.
The IOP reduction from a baseline of 18.6 mm Hg to 16.2 mm Hg at 10 years was paralleled by a substantial decrease in the need for medications. Many patients, initially on multiple medications, were able to reduce their drop dependence significantly or discontinue medications entirely by the study’s end. This reduction in treatment burden has a meaningful impact on patient quality of life, particularly for older adults managing multiple therapies.
CONCLUSION
For glaucoma patients undergoing cataract surgery, iStent® provides a durable solution with substantial IOP control and reduced medication dependence over a 10-year period. Its favorable safety and efficacy profile, paired with reduced treatment burden, make iStent® technologies a reliable option in long-term glaucoma care, offering both disease control and enhanced quality of life.
1. 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.
2. Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003;12(5):393-398.
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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