August 2020

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EyeWorld Journal Club
Excisional goniotomy versus trabecular micro-bypass stent implantation: A prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma


Suzanne Falkenberry, MD, Inder Paul Singh, MD, Charles Crane, MD, Mohammed Ali Haider, DO, Michael Morgan, MD, Christopher Grenier, MD, Jacob Brubaker, MD, Goundappa Balasubramani, PhD, Syril Dorairaj, MD

J Cataract Refract Surg. 2020;46(8). Article in press.

• Purpose: To compare reduction in intraocular pressure (IOP) and IOP-lowering medication in eyes undergoing excisional goniotomy with the Kahook Dual Blade (KDB) versus iStent micro-bypass implantation, both combined with phacoemulsification (phaco), in eyes with mild-moderate open-angle glaucoma (OAG).
• Setting: 9 practices in the United States.
• Design: Prospective, randomized, active-controlled, parallel-group clinical trial.
• Methods: Eyes were randomized to KDB-Phaco or iStent-Phaco. Demographics, best-corrected visual acuity, IOP, IOP-lowering medications, and adverse events were collected at baseline, day 1, week 1, and months 1, 3, 6, 12 postoperatively. The primary outcome measure was the proportion of eyes at Month 12 with IOP reduction >20% or IOP medication reduction >1 compared to baseline.
• Results: 164 eyes/164 subjects were analyzed (82 in each group). Mean IOP was reduced at Month 12 compared to baseline from 18.5 (SE 0.4) to 15.4 (0.4) mm Hg in the KDB-Phaco group and from 18.5 (0.3) to 16.1 (0.4) mm Hg in the iStent-Phaco group (p=0.24). Mean IOP-lowering medications were reduced from 1.3 (0.1) to 0.3 (0.1) in the KDB-Phaco group and from 1.4 (0.1) to 0.4 (0.1) in the iStent-Phaco group (p=0.17). Among study completers, the primary outcome was attained in 93.7% (74/79) of KDB-Phaco eyes and 83.3% (65/78) of iStent-Phaco eyes (p=0.04). Both procedures had similar safety profiles.
• Conclusion: Both procedures lowered both IOP and need for IOP-lowering medications effectively and safely in eyes with mild-moderate OAG and cataract. Significantly more KDB-Phaco eyes than iStent-Phaco eyes met the primary outcome of >20% IOP reduction or >1 medication reduction at Month 12.

Excisional goniotomy versus trabecular micro-bypass stent implantation: A prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma Excisional goniotomy versus trabecular micro-bypass stent implantation: A prospective randomized clinical
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2020-07-27T11:13:41Z
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