The Real-World Impact of iStent inject^® W on Patients’ Quality of Life

Our primary goal as glaucoma surgeons is to improve the lives of our patients. Trabecular micro-bypass devices like the iStent inject^® W (Glaukos) provide an opportunity for patients to experience a better quality of life. It can improve their visual function and ease their fears about glaucoma-related sight loss, as data from more than 300 studies show.

Traditionally, the success of glaucoma surgery was measured by the reductions in IOP and medications. Today, however, the focus is shifting to quality of life outcomes. iStent inject^® is the first and only MIGS device to show significant durable vision-related quality of life improvements in a pivotal trial.¹

PIVOTAL TRIAL RESULTS

The pivotal study of 505 patients evaluated patient-reported outcomes after iStent inject plus phacoemulsification (n = 387) or phacoemulsification alone (n = 118).¹ The Visual Functioning Questionnaire-25 (VQF-25) and the Ocular Surface Disease Index (OSDI) were used to assess the impact of surgery on patients’ overall quality of life at 1, 6, 12, and 24 months.

Patients in both groups reported improvements in their quality of life, but the improvements were greater in patients who underwent phacoemulsification combined with the iStent inject procedure.

Overall, patient-reported improvements in the iStent inject group were not confined to the immediate postoperative period and were sustained through 24 months. Patients experienced statistically significant improvements in general vision, ocular pain, and driving ability, indicating a positive impact on quality of life.

PERSONAL RESULTS

I recently reviewed the patient-reported outcomes at 4 and 12 months from 57 patients who underwent cataract surgery combined with iStent inject W using a range of questionnaires, including the European Quality of Life in Five Dimensions, Glaucoma Quality of Life - 15, Glaucoma Symptom Severity Score, and OSDI. Patient-reported improvements in ocular surface disease were also assessed.

My results (Figures 1 and 2) mirrored the trends observed in larger studies, demonstrating consistent improvements in general health, quality of life, and ocular surface signs at 4 months, and these were maintained at 12 months. The improvement in the OSDI was more pronounced in patients who were medication-free after surgery, underscoring the importance of considering not only glaucoma control but also the overall enhancement of patients’ lives when opting for procedures like combined phacoemulsification and iStent inject W.

CONCLUSION

Being aware of quality of life outcomes, in addition to the traditional metrics of IOP and glaucoma drop reduction has benefitted the care I can provide my patients. In general, patients' eyes are more comfortable and they express high satisfaction after cataract surgery combined with iStent inject W.

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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