Second-Generation Trabecular Micro-Bypass Stents as Standalone Treatment for Glaucoma: A 36-Month Prospective Study

Abstract

Introduction: To evaluate long-term outcomes following stand-alone implantation of two second-generation trabecular micro-bypass stents (iStent inject Ò , Glaukos Corp., San Clemente, CA, USA) in eyes with predominantly primary open-angle glaucoma (POAG) and considerable preoperative disease burden. Methods: Eyes with POAG, pseudoexfoliative glaucoma (PXG), appositional narrow-angle glaucoma (NAG, with open-angle configuration in the area of implantation), or secondary glaucoma were included in this prospective, non-randomized, consecutive case series. All eyes underwent ab interno iStent inject implantation as a sole procedure. Assessments through 36 months included IOP, medications, corrected distance visual acuity (CDVA), secondary glaucoma surgeries, and complications and adverse events. Results: Two iStent inject stents were implanted in 44 consecutive eyes (POAG = 38, PXG = 4, appositional NAG = 1, secondary neovascular glaucoma = 1) of 31 patients, and 33 eyes had 36-month follow-up data. Preoperative mean IOP was 25.3 ± 6.0 mmHg on a mean of 2.98 ± 0.88 medications, with 75% of eyes on 3-5 medications, no eyes medication-free, and 50% of eyes with history of prior glaucoma surgery. At 36 months postoperatively, mean IOP reduced by 42% to 14.6 ± 2.0 mmHg (p \ 0.0001) and 87.9% of eyes achieved an IOP reduction of C 20% versus preoperatively. In addition, 97% of eyes reached IOP B 18 mmHg (vs. 9.1% preoperatively; p \ 0.0001) and 70.0% of eyes reached IOP B 15 mmHg (vs. 2.3% preoperatively; p \ 0.0001). Mean medication burden decreased by 82% to 0.55 ± 0.79 (p \ 0.0001), and 61% of eyes became medication-free. All eyes maintained or decreased their 36-month medication burden versus preoperatively. Safety was favorable, including minimal adverse events and stable CDVA through 36 months postoperatively. Conclusion: This real-world cohort of glaucomatous eyes with substantial preoperative disease burden experienced significant, sustained, safe IOP and medication reductions through 36 months following stand-alone iStent inject implantation. Funding: Article processing charges and writing assistance were provided by Glaukos Corp.

Systembiologie in der Ophthalmologie – innovative Wirkstoffidentifikation zur spezifischen Vermeidung postoperativer Fibrose

“…Als invasive Therapieformen kommen chirurgische Interventionen wie die Trabekulektomie [5] und, in den letzten Jahren vermehrt, drainierende Mikroimplantate zum Einsatz, um den IOD zu senken [6,7]. Leider sind sowohl die konventionellen chirurgischen Ansätze als auch die Implantationen alloplastischer Glaukomdrainageimplantate (GDI) bei Betrachtung der Langzeitergebnisse mangelhaft.…”

Micro-Invasive Glaucoma Surgery with the iStent inject: Impact on IOP and Medication Burden in a Real-World Setting

“…Glaucoma is the leading cause of blindness worldwide and the number of pa-tients affected with this disease increased with life expectancy [1]. In 2020 it is estimated that the global prevalence of glaucoma will be 76 million people [2].…”

“…In 2020 it is estimated that the global prevalence of glaucoma will be 76 million people [2]. Glaucoma is characterized by progressive damage of the optic nerve associated with progressive visual field defect, that is often accompanied by elevated intraocular pressure (IOP) [1].…”

“…Therefore, treatments aim to decrease IOP, given this is the primary, well established, modifiable risk factor for the progression of glaucoma [2] [3]. Topical medications are frequently used, although their effectiveness is limited by local and systemic side effects, ocular surface damage, and suboptimal patient adherence [1]. Traditional surgical treatment, trabeculectomy, involves the creation of a filtering bleb to reduce IOP.…”

“…Micro-Invasive Glaucoma Surgery (MIGS) provides an alternative to more invasive or laser surgical methods, showing consistent reductions in IOP and medication burden, while also maintaining favorable long term safety [1] [3]. The iStent inject (Glaukos Corp., San Clemente, CA, USA) is an ab interno glaucoma implant in the MIGS treatment field, [5] which includes two trabecular stents, designed to be implanted into the Schlemm canal that augments the physiologic outflow through the conventional outflow pathway [1] [5]. This device can be implanted in a standalone procedure or in combination with cataract surgery [2].…”