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Leonard Seibold, Jeffrey Kennedy, Jeffrey R Soohoo, Mina B Pantcheva, Malik Y Kahook; Safety and Efficacy of a Novel Dual Blade Device. Invest. Ophthalmol. Vis. Sci. 2016;57(12):6507.
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© ARVO (1962-2015); The Authors (2016-present)
The Kahook Dual Blade device (KDB, New World Medical, Rancho Cucamonga, CA) is designed for excision of trabecular meshwork (TM) tissue under direct gonioscopic visualization. As the device is advanced the ramp at the distal end elevates the TM allowing the two side blades to cleanly incise the tissue. The purpose of this study is to assess the safety and efficacy of the KDB device in patients with uncontrolled glaucoma.
Charts of all patients who underwent goniotomy using the KDB device between October 1, 2014 and November 30, 2015 were reviewed retrospectively. Primary outcome measures included intra-operative and post-operative complications, intraocular pressure (IOP), and number of glaucoma medications.
Thirty-two eyes of twenty-five patients were treated using the KDB device. Patient age ranged from 51-88 years (mean 71.5), and 16 (64.0%) were female. 65.6% of eyes had primary open angle glaucoma, 9.4% had chronic angle closure glaucoma and 25.0% had secondary glaucoma. Mean preoperative IOP was 18.3±5.8mmHg on 2.2±1.3 medications. On postoperative day 1, hyphema was observed in 7 eyes and inflammatory fibrin in the anterior chamber was observed in 2 eyes. Mean IOP was reduced to 13.8±3.4mmHg at 1-month follow up (n=22, p <0.001) on 1.8±1.4 glaucoma medications. To date, 5 eyes have completed three months of follow up and had mean IOP of 14.2±2.4 mmHg on 2.0±2.4 medications. Data collection and follow-up are ongoing.
In this short-term safety and feasibility assessment, the safety profile and early efficacy data of the KDB device are promising. Further study with longer-term follow up and a larger number of patients are needed to fully assess the utility of this device.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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