Glaucoma patients are seeking not only a reduction of their IOP but a substantial decrease to their medication burden and even an improvement in their visual quality and quality of life. We must manage their expectations while providing a safe, effective, and cost-beneficial procedure. The challenge lies in aligning such varied needs to create a cohesive approach to early glaucoma surgical intervention.
PATIENT SCENARIOS
Consider the following patient scenarios.
Patients A and B. Patient A has 20/20 vision but is on two glaucoma medications to treat her primary open-angle glaucoma (POAG). Patient B also has POAG and 20/20 vision but experienced a severe visual field defect. From the surgeon’s perspective, the first patient should be the happier patient.
But what about the patient perspective? The true measure of success for patients extends beyond IOP reduction. It includes a decrease in medication, long-term stability, ocular and systemic side effects, and cost effectiveness. Medical treatment is therefore not always the best option for patients. In some cases, surgical intervention is a more appropriate choice, especially for those with mild disease. The two patient scenarios illustrate this point, and, for Patient A, severe OSD was triggered by her glaucoma medication and had a considerable negative impact on her quality of life.
Patient C. A 70-year-old patient with POAG presented with a mild cataract and mild glaucoma. He had suboptimal IOP control ranging from 16 to 25 mm Hg with medications because of poor compliance. He also suffers from OSD.
We tend to think that patients with early glaucoma are relatively happy, but, like this patient, that is not always the case. The aim of the intervention for Patients A and C therefore is to decrease medications, which should result in an improved ocular surface and quality of life. For patient C, one option was cataract surgery alone, but the more appropriate option, in my opinion, was to perform a combined procedure with a trabecular micro-bypass device like the iStent inject® W (Glaukos). For patient A standalone iStent inject W procedure is a good option.
Patient D. A 62-year-old patient diagnosed with early glaucoma presented with a BCVA of 20/20. Her IOP was controlled at 17 mm Hg. She was, however, on maximum medications and experienced mild problems with the medication schedule. For these reasons, she asked for alternatives. Again, an iStent inject W procedure was selected because it was the best opportunity for improving her quality of life.
WHY EARLY INTERVENTION MATTERS
Surgeons are shifting away from the classic and rigid treatment algorithms that recommend medications and selective laser trabeculoplasty (SLT) as first-line treatments for glaucoma. Now, however, we have more long-term data on the efficacy and safety of trabecular MIGS procedures, especially on the iStent® technologies, so early surgery is an option that should be discussed with patients.
The efficacy of early trabecular surgery is not only about IOP reduction. Disease stability over the long term is also important. IOPs can be expected to drop to the mid-teens. Studies consistently show a significant decrease in IOP, even up to 7 years after surgery, with the iStent technologies.1-7 Results from the first- and second-generation iStents extend to 8 years and demonstrate a sustained decrease in IOP and medication use of up to 30%,8 further establishing the effectiveness of early intervention. Now, with newer generation iStents like the iStent inject® and iStent inject W, the decrease in medication use is even more substantial with an excellent IOP-lowering effect even after 4 to 5 years.
Additionally, when patients experience a decrease in their medication burden, typically there is an improvement in ocular surface health as well.9,10 In my experience, ocular surface health after iStent inject W surgery improves in about 50% to 60% of patients.
The impact on patients’ subjective experiences is also evident with the iStent technologies. A pivotal trial found improvements in general vision, ocular pain, and even driving abilities after the procedure.9
CONCLUSION
Early glaucoma intervention with trabecular micro-bypass surgery is a patient-centric strategy with a focus on quality of life, ocular surface health, and long-term disease stability. When making a treatment recommendation, clinicians should consider the benefits of early trabecular surgery in the context of medical and nonmedical patient characteristics.
1. Ahmed IIK, Sheybani A, De Francesc T, et al. Long-term endothelial safety profile with iStent inject in patients with open-angle glaucoma. Am J Ophthalmol. 2023;252:17-25.
2. Berdahl JP, Voskanyan L, Myers JS, Katz JL, Samuelson TW. iStent inject trabecular micro‐bypass stents with topical prostaglandin as standalone treatment for open‐angle glaucoma: 4‐year outcomes. Clin Exp Ophthalmol. 2020;48(6):767-774.
3. Hengerer FH, Auffarth GU, Conrad-Hengerer I. iStent inject trabecular micro-bypass with or without cataract surgery yields sustained 5-year glaucoma control. Advances in Therapy. 2022;39(3):1417-1431.
4. Ferguson TJ, Mechels KB, Dockter Z, et al. iStent trabecular microbypass stent implantation with phacoemulsification in patients with open-angle glaucoma: 6-year outcomes. Clin Ophthalmol. 2020;14:1859-1866.
5. Ziaei H, Leon A. Manchester iStent study: long-term 7-year outcomes. Eye. 2021;35(8):2277-2282.
6. Salimi A, Watt H, Harasymowycz P. Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results. Eye and Vision. 2021;8(1):1-12.
7. Healey PR, Clement CI, Kerr NM, Tilden D, Aghajanian. Standalone iStent trabecular micro-bypass glaucoma surgery: a systematic review and meta-analysis. J Glaucoma 2021;30(7):606-620.
8. Salimi A, Watt H, Harasymowycz P. Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results. Eye and Vision. 2021;8(1):1-12.
9. 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.
10. Schweitzer JA, Hauser WH, Ibach M, et al. Prospective interventional cohort study of ocular surface disease changes in eyes after trabecular micro-bypass stent(s) implantation (iStent or iStent inject) with phacoemulsification. Ophthalmology and Therapy 2020;9(4):941-953.
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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