<p>Three-year outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic population with primary open-angle glaucoma</p>

Abstract

Purpose: To present long-term, real-world outcomes after implanting one trabecular micro-bypass stent with cataract surgery for primary open-angle glaucoma (POAG) in a predominantly Hispanic patient population. Patients and methods: This retrospective, consecutive case series evaluated intraocular pressure (IOP), medications, and safety through 36 months after implanting one iStent ® during phacoemulsification cataract surgery. Eyes were stratified into 2 subgroups classified by preoperative IOP and surgical goal. The Controlled Group had IOP <18 mmHg on ≥1 medications, and goal to reduce medications. The Uncontrolled Group had IOP ≥18 mmHg and/or maximum tolerated medication load, and goal to reduce IOP. Assessments included IOP, medications, visual fields (VF), retinal nerve fiber layer thickness (RNFL), adverse events, and secondary surgeries. Results: Of 168 total operated eyes, 87 eyes (49 Controlled, 38 Uncontrolled) completed 36 months of follow-up and comprise the Consistent Cohort in this report. At baseline, 79.6% (39/49) of Controlled eyes and 71.1% (27/38) of Uncontrolled eyes were from Hispanic patients. In the Controlled Group desiring medication reduction, mean medications were reduced by 77.3% (2.6 medications preoperatively vs 0.6 at 36 months; p <0.001. All Controlled eyes maintained or reduced medications versus preoperative; no eyes were on ≥3 medications (vs 61.2% preoperatively); and 58.3% were medication-free (vs 0% preoperatively). In the Uncontrolled Group desiring IOP reduction, mean IOP decreased by 31.2% (19.4 mmHg preoperatively vs 13.4 mmHg at 36 months; p <0.001), 91.7% of eyes achieved IOP ≤18 mmHg, 69.4% reached IOP ≤15 mmHg, and 77.8% decreased IOP ≥20% vs baseline. Uncontrolled eyes also experienced a 45.3% medication reduction (2.2 medications preoperatively vs 1.2 at 36 months; p <0.001). Favorable safety included no intraoperative complications, and stable VF and RNFL through 36 months. Conclusion: In this predominantly Hispanic patient cohort, significant IOP and medication reductions were sustained safely through 36 months after iStent implantation during cataract surgery.

<p>iStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population</p>

“…To date, the safety and performance of iStent trabecular micro-bypass have been established by a breadth of studies evaluating the device, including in standalone implantation or in combination with cataract surgery or other MIGS procedures, in both single-and multiple-stent usage, in populations with various levels of disease severity, and in various subtypes of glaucoma and ocular hypertension. [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] The stent has been widely adopted and studied by surgeons around the world. 43 However, iStent outcomes have not been as closely examined in Japanese populations.…”

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

“…With up to 7 years of postoperative follow-up, iStent studies have often focused on patients with mild to moderate POAG undergoing cataract surgery, but an increasing number of studies have assessed iStent for different glaucoma types (eg, pseudoexfoliative, angle-closure, pigmentary), more advanced severity, standalone cases, and in combination with other procedures or stents. [11][12][13][14][15][16][17][18][19][20][21][22][23] The more recent iStent inject ® Trabecular Micro-Bypass (CE Mark 2010, FDA approval 2018) contains two stents that create two patent bypasses through the diseased trabecular meshwork. This device has been studied both with and without concomitant cataract extraction, and in studies with up to 5 years of follow-up.…”

Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification

“…Fechtner et al also reported incrementally higher OSDI scores in patients using more glaucoma medications, with mean OSDI scores of 12.9, 16.7, and 19.4 in eyes on one, two, and three glaucoma medications, respectively [9]. Alongside such studies correlating medications with ocular surface disease, the medication reductions consistently observed after stent implantation also are well known and widely documented [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. Thus, it stands to reason that stent implantation would result in ocular surface improvement.…”

“…1a) is a 12-item subjective questionnaire designed to assess a patient's symptoms related to chronic dry eye, its severity, and its impact on ability to function [32]. OSDI scores range from 0 to 100, with severity defined as normal (0-12), mild (13)(14)(15)(16)(17)(18)(19)(20)(21)(22), moderate (23)(24)(25)(26)(27)(28)(29)(30)(31)(32), and severe (33-100). The Oxford Schema (Fig.…”

“…Both micro-scale devices are designed to create a patent pathway through the diseased trabecular meshwork into Schlemm's canal, thereby increasing aqueous humor outflow from the anterior chamber and decreasing intraocular pressure (IOP). Stent implantation has been examined in the setting of cataract surgery or as a standalone procedure, in varying glaucoma severities ranging from glaucoma suspect to refractory glaucoma, and in various glaucoma subtypes (e.g., pseudoexfoliative, pigmentary, normal-tension) as well as in primary open-angle glaucoma (POAG) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. In both long-and short-term followup, stent implantation has consistently demonstrated substantial reductions in IOP and medication burden.…”