<p>One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study</p>

Abstract

PurposeTo assess the utility and safety of implanting two second-generation trabecular micro-bypass stents following cataract surgery in eyes with mild to advanced glaucoma or ocular hypertension (OHT).Patients and methodsRetrospective study of iStent®inject trabecular micro-bypass implantation with cataract surgery by five surgeons at five sites in Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle, appositional angle-closure, or pseudoexfoliative glaucoma) or OHT and cataract requiring surgery. Effectiveness measures included intraocular pressure (IOP); medication burden; and proportions of eyes with no medications, ≥2 medications, stable or decreased medications vs preoperative, and IOP ≤18 mmHg. Safety measures included visual acuity, cup-to-disc ratio (CDR), visual field (VF), complications, adverse events, and secondary surgical interventions. Patients have been followed for 12 months, and follow-up is ongoing.ResultsOf the 290 total eyes that underwent surgery, 165 eyes had 12-month outcomes at the time of data collection and are included in this report. In these eyes, mean Month 12 IOP reduced by 23.2% from 18.27±5.41 mmHg preoperatively to 14.04±2.98 mmHg (P<0.001), with 95.8% of eyes achieving Month 12 IOP of ≤18 mmHg vs 60.6% preoperatively. Mean number of medications at 12 months decreased by 71.5%, 0.47±0.95 vs 1.65±1.28 preoperatively; 76.4% of eyes were on zero medications vs 17.6% preoperatively (P<0.001); 14.5% of eyes were on ≥2 medications vs 46.7% preoperatively (P<0.001); and 98.2% of eyes maintained or reduced medications vs their preoperative regimen. Favorable safety included no stent-related intraoperative complications; limited and transient postoperative adverse events; and stable CDR, VF, and visual acuity. Three eyes with more advanced disease underwent additional glaucoma surgeries.ConclusioniStent inject implantation with cataract surgery significantly and safely reduced medications and IOP in eyes with various types and severities of glaucoma within a multicenter, multi-provider, real-life setting.

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

“…It is noteworthy that iStent inject had a positive effect in these formerly treatment-resistant eyes. This treatment effect is consistent with prior studies showing benefit of this technology in various stages of glaucoma, from mild to advanced [40][41][42][43][44][45][46][47][48][49][50][51]. It also suggests that iStent inject may have a viable role in settings different from those typically considered for MIGS procedures: specifically, it may be considered not just in mild-to-moderate glaucoma as a primary surgery, but also in refractory eyes that have progressed despite previously undergoing more invasive surgery.…”

“…This study assessed stand-alone stent implantation, thereby allowing the device's treatment effects to be separated from those of phacoemulsification, which is known to reduce IOP to a modest degree in eyes with glaucoma [52][53][54]. Due to the stents alone, mean 36-month IOP showed a 42% decrease, a reduction consistent with those in previous studies of both combined and stand-alone iStent inject implantation [40][41][42][43][44][45][46][47][48][49][50][51]. The observation of comparable 36-month outcomes either with or without cataract surgery is not entirely surprising, since the IOP-reducing effect of cataract surgery is known to be temporary [52][53][54] and thus would be unlikely to persist through the month 36 visit.…”

“…1-2). In studies both with and without cataract surgery, and in both investigational and real-world settings, the ab interno-implanted iStent inject has demonstrated clinically significant reductions in IOP and medications over the long term [40][41][42][43][44][45][46][47][48][49][50][51]. These performance outcomes have been accompanied by favorable safety and a correspondingly advantageous benefit-to-risk profile.…”

Reply

“…In studies outside the confines of RCTs, the IOP reduction of iStent inject has been even more marked. 4,5 MIGS RCTs produce clinical situations rarely encountered outside controlled trials, specifically washedout IOP both preoperatively and postoperatively. Comparing results of stringently controlled trials with less controlled studies with different requirements for preoperative IOP and medication washout is simply without merit.…”

“…2019;126:1511-1516 TO THE EDITOR: We have taken great interest in the results of the recent SALT Trial, 1 which seems to show that postoperative treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids after selective laser trabeculoplasty (SLT) is associated with a better pressure lowering effect than treatment with placebo, a result that somewhat differs from previous studies. [2][3][4] The SALT trial is a double-blind, placebo-controlled, randomized trial. The randomization applies to which postoperative antiinflammatory treatment each research person receives.…”