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Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma

2023; Elsevier BV; Volume: 131; Issue: 3 Linguagem: Inglês

10.1016/j.ophtha.2023.09.023

1549-4713

Joseph F. Panarelli, Marlene R. Moster, J. García–Sánchez, Brian Flowers, N. Douglas Baker, Howard Barnebey, Davinder S. Grover, Anup K. Khatana, Bonny Lee, Tuan V. Nguyen, Michael C. Stiles, Omar Sadruddin, Peng T. Khaw, Steven D. Vold, Michael McFarland, Michael C. Stiles, Ann C. Stechschulte, Amanda Strom, Adam C. Reynolds, Robert Noecker, Joseph Thimons, Mahmoud A. Khaimi, Evan Allen, Steve Sarkisian, Howard Barnebey, Ernesto Golez, Robert Feldman, Nicholas P. Bell, Lauren S. Blieden, Louis B. Cantor, Darrell WuDunn, Yara Catoira-Boyle, Huiyi Chen, Joshua Evans, Elizabeth J. Martin, Yasemin Sozeri, Vinita Srivastava, Ryan J. Wise, Kenneth S. Schwartz, Davinder S. Grover, Michelle R. Butler, Matthew E. Emanuel, Ronald L. Fellman, David G. Godfrey, Oluwatosin Smith, Helen L. Kornmann, Anup K. Khatana, Daniel Hagee, Brian Kuhlman, Jeffrey M. Zink, Marlene R. Moster, E Dale, Michael J. Pro, Douglas M. Baker, M. M. Chambers, David M. Lehmann, Joseph Caprioli, Brian A. Francis, JoAnn A. Giaconi, Simon K. Law, Kouros Nouri‐Mahdavi, Anne L. Coleman, William J. Flynn, Edward R. Rashid, Charles Reilly, Robert D. Rice, Paul A. Sidoti, Joseph F. Panarelli, Reena Garg, Tak Yee Tania Tai, Kate Vinod, Noga Harizman, Robert Ritch, George R. Reiss, Vinay N. Dewan, Shamil Patel, Christina Sorenson, Christine L. Larsen, Thomas W. Samuelson, Thomas Hansen, Tara Barth, Alyson Blakstad, Mark R. Buboltz, Ahmad Fahmy, M.D. Fahmy, Kate Montealegre, Martin W. Mizener, Peter Whitted, Michele C. Lim, James D. Brandt, Annie K. Baik, Angela Jiang, Steve Brown, A. Breunig, Madhu S.R. Gorla, И. Рисс, García J. Feijoó, Carmen Méndez-Hernández, J.M. Martínez-de-la-Casa, M PELAEZ, Ana Fernandez Vidal, Sofía García Sáenz, Laura Morales‐Fernández, F. Sáenz-Francés, Enrique Santos Bueso, Lucía Perucho González, Henny J. M. Beckers, Stefani Kujovic, Marco Nardi, Maria Novella Maglionico, Francesco Nasini, Andrea Passani, Nick Strouthidis, Keith Barton, Jonathan Clarke, Gus Gazzard, Hari Jayaram, Peng T. Khaw, Maria Papadopoulos, Renata Puertas, Márta Tóth, David Lunt, Giacinto Triolo, Ronald Kam, Jason Levine, Brian Flowers, Unnikrishnan Nair, Steven T. Simmons, Michael J. Pokabla,

Retinal Diseases and Treatments

PurposeTo compare the effectiveness and safety of the MicroShunt (Santen Inc., Emeryville, CA, USA) versus trabeculectomy in patients with primary open-angle glaucoma (POAG).DesignProspective, randomized, multicenter trial conducted in the United States and Europe.ParticipantsAdult patients (aged 40-85 years) with mild to severe POAG inadequately controlled on maximum tolerated medical therapy and intraocular pressure (IOP) ≥15 mmHg and ≤40 mmHg.MethodsPatients were randomized 3:1 to standalone MicroShunt implantation (n=395) or trabeculectomy (n=132), both augmented with mitomycin C (MMC) 0.2 mg/mL for 2 minutes.Main Outcome MeasuresThe primary effectiveness endpoint was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline with no increase in glaucoma medications. Secondary endpoints included changes in mean IOP and medication use from baseline and the need for postoperative interventions.ResultsAt 2 years, the rate of surgical success was lower in the MicroShunt than in the trabeculectomy group (50.6% versus 64.4%, p=0.005). Mean diurnal IOP was reduced from 21.1 ± 4.9 mmHg at baseline to 13.9 ± 3.9 mmHg at 24 months in the MicroShunt group and from 21.1 ± 5.0 mmHg at baseline to 10.7 ± 3.7 mmHg at 24 months in the trabeculectomy group (p<0.001 compared with baseline in both groups). Mean medication use decreased from 3.1 to 0.9 in the MicroShunt group and from 2.9 to 0.4 in the trabeculectomy group (p<0.001 compared with baseline in both groups). Adverse events at 2 years were generally similar in the two groups, except that hypotony was more common in eyes undergoing trabeculectomy (51.1% versus 30.9%, p<0.001). Repositioning or explantation of the implant occurred in 6.8% of MicroShunt patients. The majority of these patients had device removal at the time of subsequent glaucoma surgery. Vision-threatening complications were uncommon in both groups.ConclusionAt 2 years, both the MicroShunt and trabeculectomy provided significant reductions in IOP and medication use, with trabeculectomy continuing to have greater surgical success.