Outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic patient population

Abstract

PurposeThe purpose of this study was to evaluate intraocular pressure (IOP) and topical ocular hypotensive medication burden at 12 months postoperatively in a predominantly Hispanic patient population with primary open-angle glaucoma each implanted with one trabecular micro-bypass stent during cataract surgery.MethodsThis was a retrospective, consecutive case series. The main objective was to assess reduction of IOP and/or medication burden in all eyes at the 12-month postoperative exam. A secondary objective was to assess outcomes in 3 subgroups, distinguished preoperatively by IOP control and by medication burden (suboptimal or maximum therapy) and with different treatment goals. Group 1 had medication-controlled IOP and goal to reduce medications while maintaining IOP control (n=65); Group 2 had uncontrolled IOP on ≤2 medications and goal to reduce IOP and maintain/reduce medication burden (n=31); and Group 3 had uncontrolled IOP on ≥3 medications and goal to reduce IOP and avoid filtering surgery (n=38). Evaluations included IOP, medication use, cup-to-disc ratio, visual fields, complications, and interventions. One hundred subjects (134 eyes) have been followed for 12 months.ResultsMost patients (80%) were Hispanic and had moderate or severe glaucoma (87%). At 12 months, mean IOP reduced to 12.9 mmHg vs 16.5 mmHg preoperatively; 92% had an IOP ≤15 mmHg at 12 months (99% had ≤18 mmHg). Mean medication burden had decreased to 0.9 vs 2.3 preoperatively. At the 12-month time point, 94% of all eyes achieved their predefined treatment goal of reduced IOP and/or medications. Reductions in medication burden for Group 1, and in IOP for Groups 2 and 3, were highly statistically significant (P<0.001). Two eyes in Group 3 had filtering surgery; the remaining 95% avoided such treatment. No other complications were reported.ConclusionThis mainly Hispanic population with predominantly moderate or severe glaucoma had substantial reduction of IOP and medication and favorable safety for 12 months following stent implantation during cataract surgery, with treatment success achieved in all 3 subgroups. These data show this stent technology to be effective in Hispanic eyes with more advanced disease.

Prospective Evaluation of Two iStent® Trabecular Stents, One iStent Supra® Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes

“…Meanwhile, iStent technology has predominantly been used in cases of mild to moderate OAG, where it has demonstrated long-term effectiveness and excellent safety [ 3 – 6 , 9 – 20 ]. However, several recent reports have shown that the iStent may also be beneficial in cases of more advanced disease [ 7 , 8 , 31 – 33 ]. Given the difficulty of treating refractory disease, and the risk profile associated with more invasive traditional interventions, the present study offers insight into a novel minimally invasive treatment approach for these patients.…”

“…Meanwhile, for more severe OAG, including refractory cases, treatments have typically involved incisional glaucoma surgeries such as trabeculectomy or tube shunts, with attendant immediate and long-term risks of sequelae such as endophthalmitis, hypotony, bleb leaks, fibrosis, and bleb infections [ 21 – 30 ]. In more recent years, however, emerging literature has pointed to the potential utility of trabecular micro-bypass stents for these more advanced glaucoma cases [ 7 , 8 , 31 – 33 ]. Going one step further, some recent studies have examined the effect of simultaneously increasing two forms of outflow via two proven treatment modalities (conventional outflow via trabecular micro-bypass, and both uveoscleral and conventional outflow via a prostaglandin analogue) [ 15 , 20 , 34 ].…”

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

“…To date, this device has amassed a sizable longterm evidence base regarding its safety and performance in eyes with open-angle glaucoma, in settings both with and without cataract surgery. Most studies of the device have assessed outcomes in mild to moderate glaucoma [17][18][19][20][21][22][23][24][25][26][27], but other patient populations increasingly have been the subject of evaluation, such as pseudoexfoliative glaucoma, severe or refractory glaucoma, or newly diagnosed, treatment-naïve glaucoma [28][29][30][31][32][33]. Another growing and relevant area of investigation has been economics outcomes research [34][35][36][37][38][39], which consistently has shown favorable cost-effectiveness of the iStent in various healthcare models around the world.…”

Efficacy and Adverse Event Profile of the iStent and iStent Inject Trabecular Micro-bypass for Open-angle Glaucoma: A Meta-analysis

“… 29 Differences in outcomes between single versus multiple iStents have also been investigated. 11 13 14 17 20 21 23 - 25 29 31 In general, most studies have focused on patients with early stages of primary OAG 11 14 - 16 21 22 27 - 29 32 …”