iStent inject trabecular microbypass stent implantation with cataract extraction in open-angle glaucoma: early clinical experience.

BACKGROUND: Retrospective, consecutive case series to evaluate the implantation of two second-generation trabecular microbypass stents in combination with cataract surgery in a real-world, clinical setting. METHODS: The series included 56 eyes implanted with the iStent inject device with phacoemulsification. The series consisted of eyes with primary open-angle glaucoma (n = 52) and pseudoexfoliative glaucoma (n = 4). Primary outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes ≥10 mmHg and ≥ 15 mmHg. RESULTS: IOP was reduced by 21% to 14.7 ± 2.9 mmHg (p < 0.01) at 6 months postoperative from 18.7 ± 5.8 mmHg at baseline. Preoperatively, the mean number of glaucoma medications was 1.5 ± 0.9 and reduced by 39% to 0.9 ± 1.2 (p < 0.01) at 6 months. At 6 months, 68% of eyes had an IOP ≤15 mmHg, increased from 30% at baseline. 55% of eyes were medication-free at 6 months, up from 18% at baseline. There were no severe postoperative complications. No eyes underwent an additional glaucoma procedure. CONCLUSIONS: Implantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative. The safety profile is excellent.

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

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.

Trabecular micro-bypass stent implantation with cataract extraction in pigmentary glaucoma.

IMPORTANCE: Use of the trabecular micro-bypass stent with cataract surgery is well established to be safe and effective in primary open-angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma. BACKGROUND: This study aimed to investigate the safety and efficacy of a trabecular micro-bypass stent in combination with cataract surgery in pigmentary glaucoma. DESIGN: Retrospective, consecutive case series. PARTICIPANTS: Twenty-four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro-bypass stent with concomitant cataract surgery. METHODS: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure. MAIN OUTCOME MEASURES: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery. RESULTS: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P < .01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P > .05) at 36 M. At the 36 M time-point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure. CONCLUSIONS AND RELEVANCE: The insertion of a single trabecular micro-bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery.