Eyeworld

26 | EYEWORLD | AUGUST 2020 ASCRS NEWS Contact Gedde: sgedde@med.miami.edu the aforementioned randomization. Finally, the utilization of a standardized surgical approach based on the manufacturer's Directions for Use helped control for surgeon-specific differences in technique. Conclusion We applaud the authors for conducting the first prospective, randomized clinical trial comparing the KDB and iStent in combination with phaco in eyes with mild to moderate open angle glau- coma. Overall, KDB-phaco and iStent-phaco groups had comparable reductions in IOP and need for IOP-lowering medications with similar safety profiles. The authors report KDB-phaco significantly achieved "patient-specific" surgical success compared to the iStent-phaco group. However, statistical significance was not found when comparing IOP reduction or medication reduction alone, so it's unclear to what extent these approaches differ. Additional randomized clinical trials are needed to better characterize the indications and outcomes of various MIGS procedures. patients in this study over a longer period of time. Including disease-specific outcome mea- sures such as visual field and retinal nerve fiber layer analysis would have also been helpful in judging the efficacy of the treatments. Cataract surgery alone has been shown to reduce IOP and, in turn, the number of IOP-lowering medications. 10 This means that each patient in this study, in effect, received two IOP-lowering procedures: phaco and either KDB or iStent. Including a separate phaco-only group for comparison would have been helpful for readers interested in the additive effects of angle-based procedures in phaco-MIGS. There are also newer techniques and technologies per- tinent to the iStent such as the use of multiple implants and the iStent inject, which were not explored despite their place in current practice. Despite these limitations, the study is an important contribution to the medical litera- ture. The randomization technique appeared successful as demonstrated by the balanced baseline data/demographics. The use of intention-to-treat analysis was also a strength and further reduced bias when coupled with continued from page 25 n n n n n n n n n 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. n 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. n 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. n 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). n Setting: 9 practices in the United States. n Design: Prospective, randomized, active-controlled, parallel-group clinical trial. n 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.

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