ABSTRACT
PURPOSE: To investigate the long-term safety and efficacy of an iStent trabecular microbypass stent in combination with cataract surgery in eyes with primary open-angle glaucoma (POAG). SETTING: Private practice; Sioux Falls, South Dakota. DESIGN: Retrospective, consecutive case series. METHODS: This case series included eyes implanted with a single trabecular microbypass stent in combination with phacoemulsification in patients with mild to severe POAG. Data were collected preoperatively and at day 1, week 1, month 1, and up to 6 years postoperatively. Primary outcome measures included mean intraocular pressure (IOP) and number of glaucoma medications. Safety was noted by assessing the incidence of IOP spikes and need for additional surgery. RESULTS: The study comprised 411 eyes. Mean IOP was reduced to 14.9±4.2 mmHg compared to 18.8±5.6 mmHg at baseline at 6 years postoperative. The mean number of medications was reduced to 1.2±1.0 from 1.4±1.1 at baseline. In eyes with severe stage of disease, there was a mean IOP reduction >6 mmHg at 6 years postoperative. Eyes with baseline IOP ≥18 mmHg achieved a more robust reduction in IOP. Fifteen eyes underwent a secondary glaucoma procedure. There were no intra- or postoperative complications. CONCLUSION: Trabecular microbypass stent implantation in combination with cataract surgery provides a sustained IOP reduction in eyes with mild-to-severe POAG. The degree of IOP reduction was more significant in eyes with higher baseline IOP and severe stage of disease.
ABSTRACT
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.
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.
