@article{62454e452d7943e9be1ce061972264a3,
title = "Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study",
abstract = "Purpose: To compare the effectiveness and safety of the MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG). Design: One-year results from a 2-year, prospective, randomized, multicenter, noninferiority study (NCT01881425) conducted in the United States and Europe. Participants: Eligible patients were aged 40-85 years with intraocular pressure (IOP) >15 and 20% reduction in mean diurnal IOP from baseline (no medication washout) at year 1 without increasing the number of glaucoma medications. Secondary effectiveness end points at year 1 were the mean IOP change from baseline and requirement for postoperative intervention. Additional end points included glaucoma medication use and adverse events. Results: Overall, 395 (MicroShunt) and 132 (trabeculectomy) patients were randomized (mean Humphrey visual field mean deviation, -12.34 decibels [dB]). At year 1, probability of success was lower in the MicroShunt group compared with the trabeculectomy group (53.9% vs. 72.7%, respectively; P < 0.01). In the MicroShunt group, mean IOP +/- standard deviation decreased from 21.1 +/- 4.9 mmHg at baseline to 14.3 +/- 4.3 mmHg (-29.1%; P < 0.01) at year 1, with a mean of 0.6 +/- 1.1 glaucoma medications (baseline 3.1 +/- 1.0; P < 0.01). In the trabeculectomy group, mean IOP decreased from 21.1 +/- 5.0 mmHg to 11.1 +/- 4.3 mmHg (-45.4%; P < 0.01), with a mean of 0.3 +/- 0.9 glaucoma medications (baseline 3.0 +/- 0.9; P < 0.01). Postoperative interventions, including laser suture lysis, were reported in 40.8% (MicroShunt) versus 67.4% (trabeculectomy) of patients (P < 0.01). Reported incidence of transient hypotony was higher in the trabeculectomy group versus the MicroShunt group (49.6% vs. 28.9%; P < 0.01). Vision-threatening complications were uncommon and reported in 1.0% of MicroShunt versus 0.8% of trabeculectomy patients. Conclusions: Probability of success was lower with MicroShunt compared with trabeculectomy. Although reductions in IOP and glaucoma medications over 1 year were observed in both groups, the trabeculectomy group had a lower mean IOP on fewer medications. Ophthalmology 2021;128:1710-1721 (c) 2021 by the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).",
keywords = "Antifibrotic agents, Aqueous drainage devices, Glaucoma, Open-angle, Randomized controlled trial, Trabeculectomy, TREATMENT OUTCOMES, TUBE, POLY(STYRENE-BLOCK-ISOBUTYLENE-BLOCK-STYRENE)",
author = "Baker, {N. Douglas} and Barnebey, {Howard S.} and Moster, {Marlene R.} and Stiles, {Michael C.} and Vold, {Steven D.} and Khatana, {Anup K.} and Flowers, {Brian E.} and Grover, {Davinder S.} and Strouthidis, {Nicholas G.} and Panarelli, {Joseph F.} and {INN005 Study Group} and Helena Beckers",
note = "Funding Information: Medical writing support, including preparation of manuscript drafts for critical revision and approval by the authors in accordance with GPP3, was provided by Lucy Cartwright, MChem, Helios Medical Communications, which was funded by Santen Inc. The study was sponsored by InnFocus Inc, a Santen Pharmaceutical Co. Ltd Company. The authors thank all of the investigators who participated in this study and Santen for their support in the development of this manuscript, in particular Dr. Hui Shao and Dr. Phillip Dinh for statistical support and data analysis, and Dr. Omar Sadruddin and Dr. Leonard Pinchuk for their critical review of the data presented. The authors would like to pay their tributes to Dr. Francisco Fantes, co-inventor of the MicroShunt and the inspiration behind its development, who sadly passed away during the early clinical studies of the MicroShunt. Funding Information: Medical writing support, including preparation of manuscript drafts for critical revision and approval by the authors in accordance with GPP3, was provided by Lucy Cartwright, MChem, Helios Medical Communications, which was funded by Santen Inc. The study was sponsored by InnFocus Inc, a Santen Pharmaceutical Co. Ltd Company. The authors thank all of the investigators who participated in this study and Santen for their support in the development of this manuscript, in particular Dr. Hui Shao and Dr. Phillip Dinh for statistical support and data analysis, and Dr. Omar Sadruddin and Dr. Leonard Pinchuk for their critical review of the data presented. The authors would like to pay their tributes to Dr. Francisco Fantes, co-inventor of the MicroShunt and the inspiration behind its development, who sadly passed away during the early clinical studies of the MicroShunt. M.R.M.: Consultant/Advisor ? Aerie, Alcon, Allergan, Qura, Santen; Lecture fees ? Aerie, Alcon, Allergan, Bausch & Lomb, Iridex, MedEdicus, Novartis; Grant support ? Aerie, Alcon, Allergan, Bausch & Lomb, Glaukos, InnFocus, Iridex, Santen; Equity/Owner ? Qura. M.C.S.: Grant support ? Allergan, Glaukos, Ivantis, Santen. S.D.V.: Consultant/Advisor ? Aerie, Alcon, Allergan, Bausch & Lomb, Carl Zeiss Meditec, Glaukos, Iridex, iSTAR Medical, Ivantis, New World Medical, Sight Sciences, Volk Optical; Grant support ? Aerie, Alcon, Allergan, Bausch & Lomb, Carl Zeiss Meditec, Glaukos, Ivantis, RxSight, Santen, Sight Sciences; Equity/Owner ? Alphaeon, Ivantis, O3 Optix; Patents/Royalty ? Iridex, Volk Optical. A.K.K.: Consultant/Advisor ? Gore Inc, Ivantis, Reliance/Haag-Streit; Lecture fees ? Aerie, Ivantis; Grant support ? Glaukos, InnFocus, Santen. B.E.F.: Consultant/Advisor ? Alcon, Bausch & Lomb, Eyenovia, Glaukos, InnFocus, iSTAR Medical, Ivantis, New World Medical, Sight Sciences; Grant support ? Eyenovia, Glaukos, InnFocus, iSTAR Medical, Ivantis, Santen, Sight Sciences. D.S.G.: Consultant/Advisor ? Allergan, MicroOptx, New World Medical, Reichert Instruments, Santen; Lecture fees ? Aerie, Allergan, Bausch & Lomb, New World Medical, Reichert Instruments; Grant support ? Allergan. N.G.S.: Funding ? NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, and UCL Institute of Ophthalmology. The sponsor or funding organization had no role in the design or conduct of this research. The views expressed are those of the authors and not necessarily those of the NHS, NIHR, or UK Department of Health. J.F.P.: Consultant/Advisor ? Aerie, Allergan, CorneaGen, Glaukos, New World Medical, Santen; Grant support ? Allergan. Obtained funding: N/A Publisher Copyright: {\textcopyright} 2021 American Academy of Ophthalmology",
year = "2021",
month = dec,
doi = "10.1016/j.ophtha.2021.05.023",
language = "English",
volume = "128",
pages = "1710--1721",
journal = "Ophthalmology",
issn = "0161-6420",
publisher = "Elsevier Science",
number = "12",
}