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67 EW GLAUCOMA November 2015 Best in glaucoma subjects with OAG and cataract at 7 clinical centers. Qualified subjects were washed out of hypotensive medications prior to surgery. Preop- erative washed-out diurnal IOP was measured using Goldmann tonom- etry. After cataract surgery, subjects were randomly assigned to receive the Hydrus Microstent (Ivantis) or no treatment. Follow-up was conducted at 1 day, 7 days, and 1, 3, 6, 12, 18, and 24 months. Exam- inations included IOP, medication use, and changes in visual status and ocular health. Wash-out and diurnal Goldmann tonometry was repeated at 12 and 24 months. Results: One-hundred eyes from 100 subjects were randomized in the study. There were no significant dif- ferences between groups in age, sex, ethnicity distribution or baseline visual acuity or glaucoma severity. Screening IOP was 18.8±3.6 mm Hg on 2.0±1.0 glaucoma medica- tions. Preoperative washed-out IOP was 26.3±4.4 in the Hydrus group and 26.6±4.2 mm Hg in the phaco group. At 2 years, medication use was 50% lower in the Hydrus group and the proportion of patients with a 20% drop in washed-out IOP was 80% in the Hydrus group com- pared to 46% in the phaco group (p=0.0004). Conclusion: Phaco with a Schlemm's canal microstent significantly lowered IOP and medication usage compared to phaco alone through 24 months in patients with OAG and cataract. Dr. Ansari: This was another MIGS study comparing patients undergoing cataract surgery plus Hydrus Microstent (Ivantis, Irvine, Calif.) with patients undergoing cataract surgery alone. The study shows that patients receiving the Hydrus Microstent had a statisti- cally significant reduction in IOP and glaucoma medication use at 1 year and 2 years. What is particularly interest- ing about this study is that it is the first randomized MIGS trial to present "wash-out" data (i.e., patients stopped their glaucoma drops prior to surgery and again at 1 year and at 2 years so that the IOP-lowering effect of the microstent without medications could be assessed). Furthermore, this study was the first in which a MIGS device statistically significantly lowered IOP at 2 years. Novel aqueous humor MicroShunt implanted alone or combined with phacoemulsification: 3-year follow-up Juan F. Batlle Sr., MD, Rachel Alburquerque, MD, Adalgisa Corona, MD, Leonard Pinchuk, PhD, DSc, Yasushi P. Kato, PhD, Esdras A. Arrieta, MD, Paul F. Palmberg, MD, PhD, Richard K. Parrish II, MD, Bruce A. Weber, BS, MBA, Jean-Marie A. Parel, PhD, FARVO Purpose: A feasibility study to eval- uate the safety and efficacy of a mi- cro-lumen aqueous drainage device made of poly(styrene-block-isobu- tylene-block-styrene) (SIBS), the InnFocus MicroShunt, used intraop- eratively with mitomycin-C (MMC), alone or in combination with phacoemulsification and intraocular lens (IOL) implantation. Methods: Prospective nonrandom- ized study of 23 eyes in 23 primary trabeculectomy-stage patients who failed maximum tolerated glaucoma medication. Patients received a Mi- croShunt with intraoperative MMC (0.4 mg/mL, 3 minutes) either as an alone procedure or in combination with cataract surgery. A MicroShunt is implanted ab externo through a 3 mm-long needle tract in the sclera, draining aqueous humor from the anterior chamber to under the con- junctiva and Tenon's capsule. Main outcome measures include success rate (IOP ≤21 mm Hg and ≥20% reduction in IOP from baseline), IOP, visual fields, visual acuity, medica- tion use, and adverse events with 3 years of follow-up. Results: The MicroShunt was im- planted in 14 eyes alone and 9 eyes combined with cataract surgery. At 3 years (n=22), the qualified success rate (with or without glaucoma medication) was 95%; the complete success rate (with glaucoma medi- cation) was 73%; the mean IOP was reduced from 23.8±5.3 to 10.7±3.5 mm Hg (55%); mean glaucoma medications was reduced from 2.4±0.9 to 0.5±0.9, respectively. The most common complications were immediate postoperative transient hypotony (13%, 3/23) and transient choroidal effusion (8.7%, 2/23); all spontaneously resolved without sequelae. There were no sight-threat- ening long-term adverse events. Conclusion: The InnFocus Micro- Shunt transscleral aqueous drainage tube implanted with MMC is a safe standalone as well as combined pro- cedure with cataract surgery. Mean IOP reductions of >50% to approxi- mately 10 mm Hg are achieved and sustained for 3 years. Results are comparable to trabeculectomy with MMC without the need for scleral dissection. Dr. Ansari: Another interesting pair of studies involved novel devices to shunt aqueous humor to the subconjunctival space. The study by Juan Batlle, MD, and colleagues described results of the ab externo implantation of the Inn Focus MicroShunt (InnFocus, Miami) into the anterior chamber along with application of mitomycin-C (MMC). Davinder Grover, MD, and colleagues also presented data on the XEN Gel Stent (AqueSys, Aliso Viejo, Calif.), which is implanted via an ab interno approach with one end of the device re- maining in the anterior chamber while the other end is in the subconjunctival space creating a filtering bleb. This procedure is also done in concert with application of MMC. These procedures create filtering blebs similar to that seen with a trabeculectomy. Both authors presented impressive IOP reduction results, and both procedures may offer a safe and effective alternative to stan- dard trabeculectomy. EW Editors' note: Dr. Ansari is in practice at Ophthalmic Consultants of Boston. He has financial interests with Ivantis. Contact information Ansari: hansari@eyeboston.com View Dr. Ansari's presentation at Clinical.EWrePlay.org.

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