Hypotony in Patients with Uveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial

Abstract

Purpose: To assess the prevalence of hypotony in patients with severe forms of uveitis.

Methods: The Multicenter Uveitis Steroid Treatment (MUST) Trial, a randomized study, enrolled 255 patients. Patients with hypotony at the baseline visit were identified.

Results: Twenty (8.3%) of 240 patients with sufficient data had hypotony. Hypotony was more common in patients with uveitis ≥5 years duration (odds ratio [OR] = 5.0; p < .01), and in eyes with a history of ocular surgery (vitrectomy vs. none, OR = 3.1; p = .03). Hypotony was less in patients with older age of uveitis onset (>51 years vs. <51 years, OR = 0.1; p = .02), in Caucasian patients (OR = 0.1; p < .01) compared to African American patients. Hypotonous eyes were more likely to have visual impairment (OR = 22.9; p < .01).

Conclusions: Hypotony is an important complication of uveitis and more commonly affects African-American patients, those with uveitis onset at a younger age, and those with longer disease duration. It is associated with visual impairment.

Keywords::

• hypotony
• multicenter uveitis steroid treatment trial
• uveitis
• visual impairment
• visual loss

ACKNOWLEDGEMENTS

Funding/support: Supported by cooperative agreements from the National Eye Institute to Mount Sinai School of Medicine (U10 EY 014655), the Johns Hopkins University Bloomberg School of Public Health (U10 EY 014660), and the University of Wisconsin, Madison, School of Medicine (U10 EY 014656). Dr Sen’s work is supported by the National Eye Institute Intramural Research Program.

Other acknowledgments: See the credit roster in the appendix.

Declaration of interest: Bausch & Lomb provided support to the study in the form of donationof a limited number of fluocinolone acetonide implants for patients randomized to implant therapy who were uninsured or otherwise unable to pay for implants, but did not otherwise support the study. Dr. Goldstein has served as a consultant to Bausch & Lomb. Dr. Drye reports no conflict of interest. Dr. Larson reports no conflict of interest. Dr. Sen reports no conflict of interest. Dr. Merrill has served as a consultant for Bausch & Lomb and Allergan Pharmaceutical Corporation. Dr. Pavan reports no conflict of interest. Dr. Sheppard has served as a consultant or Bausch & Lomb, Alcon Laboratories, Allergan Pharmaceutical Corporation, Lux Biosciences, and EyeGate Pharmaceuticals, and Inspire Pharmaceuticals. Ms. Burke reports no conflict of interest. Dr. Srivastava has served as a consultant for Bausch & Lomb, Alimera, Novartis Pharmaceuticals Corporation, and Allergan Pharmaceutical Corporation. Douglas A. Jabs, MD, MBA has acted as a consultant for Ciba Vision, Bayer Corporation, Novartis Pharmaceutical Corporation, Centocor, Inc., and SmithKline Beecham. Currently, Dr. Jabs is a consultant for Abbott Laboratories, Alcon Laboratories, Allergan Pharmaceutical Corporation, Corcept Therapeutics, GenenTech, Genzyme Corporation, GlaxoSmithKline, Novartis Pharmaceuticals Corporation, and Roche Pharmaceuticals. Research support has been provided from Roche Laboratories, Inc. in the past. Dr. Jabs currently acts as a Data and Safety Monitoring Board (DSMB) member for Applied Genetic Technologies Corporation (AGTC).

APPENDIX: CREDIT ROSTER

Participating Clinical Centers

Duke Eye Center, Durham, NC: Glenn J. Jaffe, MD (Director); Brenda Branchaud, COT; Shelley Day, MD; Annie Lee, MD; Cindy Skalak, RN, COT; Megan Wood, MS, COA. Former Members: Claxton Baer, MD; Joyce Bryant, COT; Sai Chavala, MD; Michael Cusick, MD; Pouya Dayani, MD; Justis Ehlers, MD; Muge Kesen, MD Alex Melamud, MD; Jawad A. Qureshi, MD; Adrienne Williams Scott; Robert F. See, MD; Robert K. Shuler, MD.

Emory University, Atlanta, GA: Steven Yeh, MD (Director); Alcides Fernandes, MD; Deborah Gibbs, COMT, CCRC; Donna Leef, COMT. Former members: Daniel F. Martin, MD; Sunil Srivastava, MD.

Johns Hopkins University, Baltimore, MD: James P. Dunn, MD (Director); Ellen Arnold, BS; Patricia M. Barnabie, BS; Jeff Boring, COA; Diane M. Brown, MSN, RN; Theresa Gan, MD; Alison G. Livingston, BSN, RN; Kisten D. Nolan, MPH, RN; Terry Reed, COA. Former members: Marie-Lynn Belair, MD; Stephen G. Bolton, CRNP; Joseph B. Brodine; Lisa M. Brune, BSN, RN; Anat Galor, MD; Adam Jacobowitz, MD; Meera Kapoor; Sanjay Kedhar, MD; Stephen Kim, MD; Henry A. Leder, MD; Yavette Morton; Kisten Nolan, BSN, MPH, RN; George B. Peters, MD, MBA; Priscilla Soto; Ricardo Stevenson, MD; Michelle Tarver-Carr, MD, PhD; Yue Wang, MD. Massachusetts Eye Research and Surgery Institute, Cambridge, MA: C. Stephen Foster, MD (Director); Linda Bruner; David M. Hinkle, MD; Jyothir Johnson; Danielle Marvell; Sana S. Siddique. Former members: Sarah Acevedo, MD; Fahd Anzaar, MD; Tom Cesca; Angelica Contero; Kayleigh Fitzpatrick; Karina Q. Lebron, MD; Chandra Morgan; Nita Patel, MSW; Jennifer Pinto; Janet Sprague; Taygan Yilmaz.

National Eye Institute, Bethesda, MD: H. Nida Sen, MD, MHSc (Director); Michael Bono; Denise Cunningham, CRA; Darryl Hayes, COA; Dessie Koutsandreas, BS, COA; Nupura Krishnadev, MD; Theresa Larson, MD; Annal D. Meleth, MD; Robert B. Nussenblatt, MD; Patti R. Sherry, BSN; Gregory L. Short, COMT; Wendy Smith, MD; Alana Temple, BSN. Former members: Allison Bamji, RN; Hanna Coleman, MD; Geetaniali Davuluri, MD; Lisa Faia, MD; Chloe Gottlieb, MD; Guy V. Jirawuthiworavong, MD; Julie C. Lew, MD; Richard Mercer, COT; Dominic Obiyor, BSN; Cheryl H. Perry, BSN; Natalia Potapova, MD; Eric Weichel, MD; Keith J. Wroblewski, MD; Steven Yeh, MD.

New York Eye & Ear Infirmary, New York, NY: Paul A. Latkany, MD (Director); Jason Badamo; Jenny Gallardo; Monica Lorenzo-Latkany, MD; Robert Masini; Susan Morell; Ann Nour; Meredith Sanchez; Former members: Kenneth M. Boyd; Jacek Jarczynski; Mirjana McGrosky; Kate Steinberg.

Royal Victorian Eye & Ear Hospital, East Melbourne, Australia: Richard J. Stawell, MD (Director); Lisa Breayley; Carly D’Sylva; Elizabeth Glatz; Lauren Hodgson; Ignatios Koukouras; Lyndell Lim, MD; Cecilia Ling, MD; Rachel McIntosh; Julie Morrison (Ewing); Andrew Newton; Richard Smallwood; Ehud Zamir, MD. Former members: Nicola Hunt; Lisa Jones; Suzanne Williams.

Rush University Medical Center, Chicago, IL: Pauline T. Merrill, MD (Director); Pam Hulvey; Elaine Kernbauer; Denise L. Voskuil-Marre, BS. Former members: Bruce Gaynes; Christina Giannoulis; Heena S. Khan, BA; Sarah J. Levine; Scott Toennessen.

Texas Retina Associates, Dallas, TX: Robert C. Wang, MD (Director); Hank Aguado; Sally Arceneaux; Gary E. Fish, MD; Nick Hesse; Diana Jaramillo; Michael Mackens; Karin Mutz; Brenda Sanchez. Former members: Jean Arnwine; David Callanan, MD; Kimberly Cummings; Keith Gray; Susie Howden.

United Kingdom Institute of Ophthalmology, London, UK: Susan Lightman, MD, PhD (Director); Simon Taylor; Rebecca Tronnberg. Former members: Kate Edwards; Lavanish Joshi; Timothy Stubbs; Hamish Towler.

University of California at Los Angeles, Los Angeles, CA: Gary N. Holland, MD (Director); Robert D. Almanzor, COA; Jose Castellanos, COT; Jean Pierre Hubschman, MD; Ann K. Johiro, NP; Partho S. Kalyani, MD; Ralph D. Levinson, MD; Susan S. Ransome, MD. Former members: Christine R. Gonzales, MD; Anurag Gupta, MD; Michael A. Kapamajian, MD; Peter J. Kappel, MD.

University of California at San Diego, San Diego, CA: William R. Freeman, MD (Director); Igor Kozak, MD; Vivian Nguyen; Debbie Powell, BBA. Former members: Tom Clark, BSc, CRA; Denine E. Cochran, COT, CCRC, Joshua Hedaya, MD; Tiara Kemper; Jacqueline M. LeMoine; Megan E. Loughran, BA; Luzandra Magana; Francesca Mojana, MD; Victoria Morrison, MD; Stephen F. Oster, MD.

University of California at San Francisco, San Francisco, CA: Ira G. Wong, MD (Director); Nisha Acharya, MD; Debra Brown; David Clay; Claire M. Khouri, BA; Salena Lee, BA, OD; Mary Lew, BA; Todd P. Margolis, MD, Jay Stewart, MD.

University of Illinois at Chicago, Chicago, IL: Debra A. Goldstein, MD (Director); Anna L. Castro-Malek. Former members: Catherine E. Crooke; Melody Huntley; Marcia Niec; Dimitry Pyatetsky, MD; Misel Ramirez; Howard H. Tessler, MD.

University of Miami, Miami, FL: Janet L. Davis, MD (Director); Thomas A. Albini, MD;

Ariana Elizondo, BS, CCRP; David A. Pinto. Former members: Daniela Castaño; Marie Chin; Macy Ho; Jaclyn L. Kovach, MD; Richard C-S Lin, MD; Efrem Mandelcorn; Jackie K-D Nguyen, MD; Aura Pacini; Susan Pineda; Jose Rebimbas; Kimberly E. Stepien, MD; Claudia Teran.

University of Michigan, Ann Arbor, MI: Susan G. Elner, MD (Director); Rebecca Brown, COA; Linda Fournier, COA; Julie R. Gothrup, COA; Richard Hackel; Moella Hesselgrave, COA; Robert Prusak; Stephen J. Saxe, MD. Former members: Melissa Bergeron, COA; Reneé Blosser, COMT; Carrie Chrisman-McClure; Deanna Sizemore, COA.

University of Pennsylvania, Philadelphia, PA: John H. Kempen, MD, PhD (Director); James Berger; Sheri Drossner; Joan C. DuPont; Albert M. Maguire, MD; Janice Petner; Laurel Weeney. Former members: Tim Hopkins, MD; Dawn McCall; Monique McRay; Daniel Will, MD; Wei Xu.

University of South Florida, Tampa, FL: Peter R. Pavan, MD (Director); JoAnn Leto; Lori Mayor; Kim McDonald; Scott E. Pautler, MD; Wyatt Saxon; Judy Soto. Former members: Burton Goldstein, MD; Amy Klukoff; Lucy Lombright; Maria Ortiz; Susan Scymanky; Dee Dee Szalay.

University of Southern California, Los Angeles, CA: Amani Fawzi, MD; (Director); Tamara Davis; Jackie Douglass; Judith Linton; Margaret Padilla, CCRP; Sylvia Ramos; Narsing A. Rao, MD. Former members: Alexia Aguirre; Lawrence Chong, MD; Lupe Cisneros, COA; Elizabeth Corona; Dean Eliott, MD; Jesse Garcia; Rahul Khurana, MD; Jennifer Lim, MD; Rachel Mead; Julie H. Tsai, MD.

University of Utah, Salt Lake City, UT: Albert Vitale, MD (Director); Paul S. Bernstein, MD, PhD; Bonnie Carlstrom, COA; James Gilman, CRA; Sandra Hanseen, COA; Paula Morris, CRA; Diana Ramirez; Kimberley Wegner, BS, CRC.

Virginia Eye Consultants, Norfolk, VA: John D. Sheppard, MD, MMSc (Director); Brianne Anthony; Amber Casper; Lisa Felix-Kent, COA; Jeanette Fernandez, COMT; Stephen V. Scoper, MD. Former members: R. Denise Cole; Nancy Crawford; Lisa Franklin; Krista Hamelin; Jen Martin; Rebecca Marx; Gregory Schultz, DD; Joseph Webb, BS; Pamela Yeager.

Vitreoretinal Consultants, Houston, TX: Rosa Y. Kim, MD (Director); Matthew S. Benz, MD; David M. Brown, MD; Eric Chen, MD; Richard H. Fish, MD; Shayla Friday (Hay); James Major, Jr., MD, PhD; Laura Shawver; Tien P. Wong, MD. Former members: Rebecca De La Garza; Karin Mutz.

Washington University, St. Louis, MO: P. Kumar Rao, MD (Director); Rhonda Weeks. Former Members: Rajendra S. Apte, MD; Kevin J. Blinder, MD; Ashley Hartz; Pam Light; Gaurav K. Shah, MD; Russell VanGelder, MD, PhD.

Committees

Executive Committee: Douglas A. Jabs, MD, MBA (Chair); Michael M. Altaweel, MD; Janet T. Holbrook, PhD, MPH; John H. Kempen, MD, PhD; Natalie Kurinij, PhD.

Steering Committee: Douglas A. Jabs, MD, MBA (Chair); Robert D. Almanzor, COA; Michael M. Altaweel; Diane Brown; James P. Dunn, MD; James Gilman; Janet T. Holbrook, PhD, MPH; Gary N. Holland, MD; John H. Kempen, MD, PhD; Rosa Y. Kim, MD; Natalie Kurinij, PhD; Nancy Prusakowski, MS; Jennifer E. Thorne, MD, PhD. Former members: Stephen G. Bolton, RN, BSN; Lisa M. Brune, RN, BSN; Tom Clark, CRA; Larry Hubbard, MAT; Daniel F. Martin, MD; Robert B. Nussenblatt, MD.

Data, Safety and Monitoring Committee: Voting members: Janet Wittes, PhD (Chair); William E. Barlow, PhD; Marc Hochberg, MD; Alice T. Lyon, MD; Alan G. Palestine, MD; Lee S. Simon, MD. Nonvoting members: Michael M. Altaweel, MD; Janet T. Holbrook, PhD, MPH; Douglas A. Jabs, MD, MBA; Natalie Kurinij, PhD. Former members: James T. Rosenbaum, MD; Harmon Smith, PhD.

Surgical Quality Assurance Committee: John H. Kempen, MD, PhD (Chair); James P. Dunn, MD; Glenn J. Jaffe, MD. Former members: Daniel F. Martin, MD.

Medical Therapy Quality Assurance Committee: Jennifer E. Thorne, MD, PhD (Chair); Nisha R. Acharya, MD, MS; Douglas A. Jabs, MD, MBA; John H. Kempen, MD, PhD; Paul A. Latkany, MD; Robert B. Nussenblatt, MD, MPH; Albert T. Vitale, MD. Former members: Russell VanGelder, MD, PhD.

Visual Function Quality Assurance Committee: Robert D. Almanzor, COA (Chair); Judith Alexander, BA, CCRP; Jeffrey A. Boring, COA; Deborah Gibbs, COMT, CCRC; Salena Lee, OD, FAAO; Jennifer E. Thorne, MD, PhD (Advisor). Former members: Wai Ping Ng, BS.

Glaucoma Committee: David S. Friedman, MD (Chair); Anna Adler, MS; Judith Alexander, BA, CCRP; Alyce Burke, MPH; Janet T. Holbrook, PhD, MPH; Joanne Katz, ScD; John H. Kempen, MD, PhD; Nancy Prusakowski, MS; Susan Reed; Jennifer E. Thorne, MD, PhD; Husam Ansari, MD, PhD (consultant). Former members: Nicholas Cohen, MS; Sanjukta Modak, MS; Wai Ping Ng, BS.

Statistical Analysis Committee: Elizabeth A. Sugar, PhD (Chair); Lea Drye, PhD; Kevin Frick, PhD; Janet T. Holbrook, PhD, MPH; JoAnn Katz, ScD; Thomas Louis, PhD; Mark L. Van Natta, MHS. Former members: Sanjukta Modak, MS; David Shade, JD.

Resource Centers

Chairman’s Office: Mount Sinai School of Medicine, New York, NY: Douglas A. Jabs, MD, MBA (Study Chairman); Yasmin Hilal, MHS; Melissa A. Nieves, BA; Karen Pascual, MBA; Jill S. Slutsky-Sanon, MPA. Former members: Colby Glomp; Maria Stevens, CM.

University of Pennsylvania, Philadelphia, PA: John H. Kempen, MD, PhD (Study Vice-Chairman).

Coordinating Center, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD: Janet T. Holbrook, PhD, MPH (Director); Anna L. Adler, MS; Judith Alexander, BA; Jeff A. Boring, COA; Alyce E. Burke, MPH; Karen Collins; John D. Dodge; Lea T. Drye, PhD; Cathleen S. Ewing; Kevin D. Frick, PhD; David S. Friedman, MD, PhD; Rosetta Jackson; Joanne Katz, ScD; Andrea T. Lears, BS; Hope Livingston; Thomas A. Louis, PhD; Curtis L. Meinert, PhD; Jill L. Meinert; Vinnette Morrison, BS; Deborah J. Nowakowski; Nancy Prusakowski, MS; Dave M. Shade, JD; Rochelle E. Smith, BS; Karen Steuernagle; Elizabeth A. Sugar, PhD; Jennifer E. Thorne, MD, PhD; James A. Tonascia, PhD; Mark L. Van Natta, MHS; Richard Zheng, MS. Former members: Paul Chen; Nicholas Cohen, MS; Sanjukta Modak, MS; Wai Ping Ng, BS; Weijiang Shen, MS; Charles Shiflett, BS; Ada Tieman, MBA.

University of Wisconsin Fundus Photograph Reading Center, Madison, WI: Michael M. Altaweel, MD (Co-Director); Wendy K. Benz, PhD; Geoffrey Chambers, MS; Debra J. Christianson, BS; Amitha Domalpally, MD; Jacquelyn Freund, MS; Vonnie Gama; Sapna Gangaputra, MD, MPH; Kathleen E. Glander, BBA; Anne Goulding, BA; Jeffrey M. Joyce, MS; Christina N. Kruse, BA; Dawn J. Myers, BS; Susan Reed, BS; James L. Reimers, BA; Amy Remm, BS; Ruth A. Susman, BS; Dennis Thayer; Erika Treichel, DVM; Kelly J. Warren, RN, BS, MSES; Sheila M. Watson, BS, DVM; James K. White, BME; Tara Wilhelmson, BS. Former members: Margaret A. Fleischli, AB, DVM; Dennis Hafford; Susan E. Harris, MS; Larry D. Hubbard, MAT; Kristine A. Johnson; Lauren Nagle; Gwyn E. Padden-Lechten, BS; Alyson Pohlman, BA; Peggy Sivesind; Mary K. Webster, BS; Grace Zhang, BA.

National Eye Institute, Bethesda, MD: Natalie Kurinij, PhD.