Trabecular microbypass stent implantation in pseudoexfoliative glaucoma: long-term results

Abstract

Purpose: To evaluate the long-term safety and efficacy of an iStent trabecular microbypass stent in combination with cataract surgery in pseudoexfoliative glaucoma (PXG). Setting: Private practice, Sioux Falls, South Dakota, USA. Design: Retrospective, consecutive case series. Methods: Eyes with a preoperative diagnosis of PXG implanted with a single iStent trabecular microbypass stent with concomitant cataract surgery were included. Performance outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included intraoperative or postoperative complications and the need for secondary procedures. Results: The series included 117 eyes. IOP was reduced by 25% to 15.3 ± 3.7 mm Hg at 5 years postoperatively from 20.5 ± 6.6 mm Hg at baseline. The statistically significant (P < .01) 36% reduction in medication use through 36 months was not sustained, and medication use was unchanged from baseline (1.4 ± 1.0) at 5 years postoperatively (1.3 ± 1.1) (P > .05). At 5 years, 52% of eyes had an IOP of 15 mm Hg or lesser, increased from 22% at baseline. There were no severe postoperative complications; 5 eyes (4%) underwent an additional glaucoma procedure. Conclusions: Implantation of a trabecular microbypass stent with concomitant cataract surgery provided a sustained reduction in IOP up to 5 years postoperatively. The long-term safety profile of the device in this population was excellent with a low rate of postoperative IOP spikes and low percentage of eyes undergoing a secondary procedure.

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

“…In addition, the proportion of eyes with IOP ≤15 mmHg nearly doubled versus preoperative (81% at 24 months versus 42% preoperatively). Consistent with prior studies evaluating IOP-lowering treatments, 10,[15][16][17]46,47 eyes with higher baseline IOP achieved a more robust postoperative IOP reduction than eyes with lower baseline IOP. Also consistent with prior MIGS studies, 16,17,48 our data suggested a slight diminution of IOP-and medication-reducing effects after the first year postoperative.…”

“…Consistent with prior studies evaluating IOP-lowering treatments, 10,[15][16][17]46,47 eyes with higher baseline IOP achieved a more robust postoperative IOP reduction than eyes with lower baseline IOP. Also consistent with prior MIGS studies, 16,17,48 our data suggested a slight diminution of IOP-and medication-reducing effects after the first year postoperative. This is not unexpected, as stent implantation was accompanied by phacoemulsification, which is known to have mild ocular hypotensive effects (generally under 2 mmHg) in medically controlled glaucomatous eyes, and that these effects typically begin to diminish after the first year postoperative.…”

“…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.…”

“…[40][41][42][43] In addition, several publications have shown this IOP association following iStent or iStent inject implantation. [15][16][17][18]26,27 Fewer studies have evaluated the relationship between preoperative medication burden and postoperative IOP reduction. 44,45 However, to our knowledge, no MIGS pivotal trials to-date have specifically explored outcomes with stratification by preoperative IOP and medications.…”