Reducing Risk in Glaucoma Management

In the management of glaucoma, ensuring patient safety is paramount, especially when surgical interventions are considered. Trabeculectomy is a cornerstone for treating advanced glaucoma; however, it is associated with risks such as choroidal effusions, hypotony maculopathy, and endophthalmitis.¹ This case study demonstrates how the iStent inject^® W (Glaukos) serves as a minimally invasive alternative with proven safety that effectively controls IOP while accommodating the patient’s lifestyle needs.

CASE OVERVIEW

A 77-year-old woman with progressing moderate primary open-angle glaucoma presented with an IOP of 19 mm Hg despite being on four glaucoma medications. She had thin corneas (467 µm) and a developing cataract, complicating her treatment options. As the primary caregiver for her husband with Parkinson's disease, she needed a solution that would allow for rapid postoperative recovery. Although initially referred for combined trabeculectomy and cataract surgery, her circumstances necessitated a less invasive approach.

WHY I CHOSE THE ISTENT INJECT^® W

To address the patient’s desire for minimal disruption and rapid recovery, I opted for a combined cataract surgery with iStent inject^® W implantation rather than a traditional trabeculectomy after discussing that she may still require some eye drops postoperatively. The iStent^® technologies (Glaukos) have proven to be a reliable option for lowering IOP, with studies reporting low complication rates² and no statistically significant endothelial cell loss over a 5-year period compared to preoperative levels.³ More invasive procedures such as trabeculectomy carry known risks, including choroidal hemorrhage and prolonged hypotony. By selecting a less invasive option, we aimed to achieve effective IOP control while minimizing these potential complications.

DISCUSSION

When managing glaucoma, the efficacy of multiple topical medications versus surgical intervention must be carefully weighed. This patient’s reliance on four medications reflects a common issue in advanced glaucoma management: diminishing returns with polypharmacy.

Another consideration is the potential for transient and sustained IOP spikes after cataract surgery, which could further damage the optic nerve in patients with glaucoma.⁶ Given this patient’s role as a caregiver and her need for a fast recovery, traditional trabeculectomy, with its risks of hypotony, endophthalmitis, and prolonged recovery, was less ideal. The iStent inject^® W, when combined with cataract surgery, offered a minimally invasive alternative that aligned with her clinical and lifestyle needs, avoiding the high-risk complications associated with more invasive surgeries while providing effective IOP control.

OUTCOME

At 1 month postoperatively, the patient’s IOP decreased to below 10 mm Hg, and her medication load was reduced to two agents. Over the course of 2 years, her IOP stabilized at 12 mm Hg without the need for additional glaucoma medications. This substantial reduction in IOP enabled her to continue her caregiving duties without the burden of a complex medication regimen or a prolonged recovery period.

CONCLUSION

The iStent^® technologies offer a safe option for earlier intervention that can prevent disease progression while minimizing risk.² The optimal approach for each patient is not necessarily the most aggressive but the safest, taking into account disease severity, IOP targets, age, and individual patient circumstances. By choosing less invasive yet effective options such as the iStent^® technologies, we can improve patient outcomes and enhance their quality of life.⁵

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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