Glaucoma management has evolved significantly, offering a variety of procedural interventions tailored to individual patient needs. The primary goal is to reduce IOP effectively while minimizing risks and preserving future treatment options. This requires a careful assessment of disease stage, patient life expectancy, and specific treatment goals.
KEY CONSIDERATIONS IN SELECTING A GLAUCOMA PROCEDURE
The Role of Clinical Evidence
Clinical evidence is paramount in guiding surgical decisions. Procedures supported by robust data provide confidence in their long-term safety and efficacy. The iStent® technologies, for instance, have over a million implantations worldwide and are backed by multiple randomized controlled trials.1-4 Such extensive post-marketing surveillance is particularly reassuring for patients in early disease stages who require sustained IOP control over time.
Benefits of Minimally Invasive Approaches
MIGS offer significant advantages, especially for patients with early or mild glaucoma. Procedures such as the iStent inject® W trabecular microbypass achieve effective IOP reduction with minimal risk, presenting an overall safety profile similar to cataract surgery alone.1 This low-impact approach results in low rates of postoperative inflammation1 and preserves conjunctival tissue, which is crucial for maintaining future surgical options if the disease progresses.
WHY iSTENT inject® W IS AN OPTIMAL CHOICE
The iStent inject® W stands out due to several key characteristics and capabilities:
- Effective IOP control. As demonstrated in multiple randomized controlled trials, the iStent® technologies consistently help achieve target IOP levels essential for slowing glaucoma progression.1-5
- Excellent safety profile. When combined with cataract surgery, the iStent inject® W maintains an overall safety profile similar to cataract surgery alone, minimizing additional risk to the patient.1
- Efficacy across baseline IOP levels. The iStent inject® W is effective regardless of preoperative IOP,4 making it versatile for a wide range of patients.
- Enhanced quality of life. Patients treated with the iStent inject® W experience reduced dependence on medications, leading to improved adherence and quality of life.2
- Slowed visual field progression. A recent meta-analyses indicates that early intervention with iStent® technologies can slow the progression of visual field loss.5
Moreover, the iStent inject® W is accessible to both cataract and glaucoma surgeons due to its short learning curve. Its minimally invasive nature also preserves ocular structures, leaving the door open for future treatments if necessary.
CONCLUSION
Selecting the appropriate surgical approach in glaucoma care requires a balance between immediate efficacy and long-term safety and flexibility. The iStent inject® W exemplifies the benefits of MIGS, offering a well-documented, safe option that aligns with the principle of primum non nocere—first, do no harm. For patients in the early stages of glaucoma, the iStent® technologies provide effective IOP control1 while preserving future treatment possibilities and enhancing overall quality of life.2
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. 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.
3. Ahmed IIK, Sheybani A, De Francesco T, et al. Long-term endothelial safety profile with iStent inject in patients with open-angle glaucoma. Am J Ophthalmol. 2023;252:17-25.
4. 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.
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).
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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