Evaluation of a Trabecular Micro-Bypass Stent in Combination With Refractive Laser–Assisted Cataract Surgery in Patients With Glaucoma
To evaluate the safety and efficacy of the iStent Trabecular Micro-Bypass stent in combination with refractive laser-assisted cataract surgery in patients with glaucoma.
A retrospective review was conducted of 31 consecutive eyes (n) with primary open angle glaucoma and cataracts that were implanted with one iStent. Data was collected pre-operatively, and at post-operative day 1, week 1, month 1, month 3 and month 6. Data included mean IOP, number of glaucoma medications, visual acuity, and incidence of post-operative pressure spikes increase of greater than 15 mmHg at any time point, and need for additional surgery.
Mean pre-operative IOP was 17.87 mmHg +/- 7.63 mmHg. Mean IOP at 6 months was 13.40 mmHg +/- 2.27 mmHg (p<0.001). Mean pre-operative medication use was 0.967 medications +/-0.948 and post-operative month 6 was 0.2 medications +/-0.422 (p<0.001). Mean preoperative best-corrected visual acuity was 0.32 +/-0.28. 6 month post-operative, the best corrected visual acuity was 0.16 +/-0.26. At 3 months post-operative, the mean best-uncorrected visual acuity was 0.19 +/- 0.15. Two patients (6.45%) had a pressure spike IOP increase greater than 15 mmHg at post-operative week one that responded to topical therapy.
The insertion of the iStent Trabecular Micro-Bypass stent in combination with refractive laser-assisted cataract surgery is effective at lowering IOP in primary open angle glaucoma patients. The refractive effects of the iStent were minimal. The safety profile appears favorable with a low rate of IOP spikes. Post-operative medication use was also reduced and was minimal at 6-months post operative with 80% of the eyes completely off of hypotensive medications.