ABSTRACT
PURPOSE: To describe 12-month intraocular pressure (IOP) and medication use outcomes following excisional goniotomy (EG) as a stand-alone procedure in eyes with medically uncontrolled glaucoma. METHODS: This was a retrospective analysis of data from surgeons at 8 centers (6 US, 2 Mexico). Eyes with glaucoma undergoing standalone EG with a specialized instrument (Kahook Dual Blade, New World Medical, Rancho Cucamonga, CA) for IOP reduction and followed for 12 months postoperatively were included. Data were collected preoperatively, intraoperatively, and 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. The primary outcome was reduction from baseline in IOP, and key secondary outcomes included IOP-lowering medication reduction as well as adverse events. RESULTS: A total of 42 eyes were analyzed, of which 36 (85.7%) had mild to severe primary open-angle glaucoma (POAG). Mean (standard error) IOP at baseline was 21.6 (0.8) mmHg, and mean number of medications used at baseline was 2.6 (0.2). At 3, 6, and 12 months postoperatively, mean IOP reductions from baseline were 4.6 mmHg (22.3%), 5.6 mmHg (27.7%), and 3.9 mmHg (19.3%) (p≤0.001 at each time point). At the same time points, mean medications reductions of 0.7 (25.8%), 0.9 (32.6%), and 0.3 (12.5%) medications were seen (p<0.05 at months 3 and 6, not significant at month 12). Six eyes (14.3%) underwent additional glaucoma surgery during the 12-month follow-up period. DISCUSSION: Standalone EG with KDB can reduce IOP, and in many cases reduce medication use, through up to 12 months in eyes with mild to severe glaucoma. Statistically significant and clinically relevant reductions in IOP were seen at every time point. While the goal of surgery was not to reduce medication burden, mean medication use was significantly reduced at all but the last time point. In the majority of eyes, the need for a bleb-based glaucoma procedure was delayed or prevented for at least 12 months.
ABSTRACT
INTRODUCTION: To characterize the reduction in intraocular pressure (IOP) and IOP-lowering medication use following goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade as a stand-alone procedure in adult eyes with glaucoma uncontrolled on a regimen of 1-3 topical IOP-lowering medications. METHODS: In this retrospective analysis, data from consecutive patients undergoing goniotomy with the Kahook Dual Blade by 11 surgeons were analyzed. Preoperative, intraoperative, and postoperative follow-up data through 6 months of follow-up were collected. The primary efficacy endpoint was IOP reduction from preoperative baseline; reduction in IOP-lowering medication use was a secondary endpoint. RESULTS: Data were collected from 53 eyes of 42 subjects. Mean (± SE) preoperative IOP was 23.5 ± 1.1 mmHg, and from day 1 through 6 months of postoperative follow-up mean IOP reductions of 7.0-10.3 mmHg (29.8-43.8%; p < 0.001 at each time point) were observed. Mean preoperative medication use was 2.5 ± 0.2 medications per eye and was reduced by month 6 to 1.5 ± 0.2 (a 40.0% reduction; p < 0.05). Eyes with higher baseline IOP experienced mean IOP reductions of 13.7 mmHg (- 46.4%) at month 6, while eyes with lower baseline IOP experienced mean IOP reductions of 3.8 mmHg (- 21.0%) at month 6. Mean medications were reduced by 1.3 medications in high-IOP eyes and by 0.9 in low-IOP eyes at month 6. No significant sight-threatening adverse events were observed. CONCLUSIONS: Goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade effectively and safely lowered IOP when performed as a stand-alone procedure in eyes with glaucoma. The significant drop in IOP met or exceeded the recommended targets for these glaucoma patients. FUNDING: New World Medical, Inc.
