1. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study
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Janet T. Holbrook, Elizabeth A. Sugar, Alyce E. Burke, Albert T. Vitale, Jennifer E. Thorne, Janet L. Davis, Douglas A. Jabs, Glenn J. Jaffe, Brenda Branchaud, Paul Hahn, Larry Koreen, Eleonora (Nora) M. Lad, Phoebe Lin, Joseph Nissim Martel, Neha (Shah) Serrano, Cindy Skalak, Lejla Vajzovic, Claxton Baer, Joyce Bryant, Sai Chavala, Michael Cusick, Shelley Day, Pouya Dayani, Justis Ehlers, Muge Kesen, Annie Lee, Alex Melamud, Jawad A. Qureshi, Adrienne Williams Scott, Robert F. See, Robert K. Shuler, Megan Wood, Steven Yeh, Alcides Fernandes, Deborah Gibbs, Donna Leef, Daniel F. Martin, Sunil Srivastava, James P. Dunn, Hosne Begum, Jeff Boring, Kristen L. Brotherson, Bryn Burkholder, Nicholas J. Butler, Dennis Cain, Mary A. Cook, David Emmert, Janis R. Graul, Mark Herring, Ashley Laing, Theresa G. Leung, Michael C. Mahon, Ahmafreza Moradi, Antonia Nwankwo, Trucian L. Ostheimer, Terry Reed, Ellen Arnold, Patricia M. Barnabie, Marie-Lynn Belair, Stephen G. Bolton, Joseph B. Brodine, Diane M. Brown, Lisa M. Brune, Anat Galor, Theresa Gan, Adam Jacobowitz, Meera Kapoor, Sanjay Kedhar, Stephen Kim, Henry A. Leder, Alison G. Livingston, Yavette Morton, Kisten Nolan, George B. Peters, Priscilla Soto, Ricardo Stevenson, Michelle Tarver-Carr, Yue Wang, C. Stephen Foster, Stephen D. Anesi, null Linda Bruner, Olga Ceron, David M. Hinkle, Nancy Persons, Bailey Wentworth, Sarah Acevedo, Fahd Anzaar, Tom Cesca, Angelica Contero, Kayleigh Fitzpatrick, Faith Goronga, Jyothir Johnson, Karina Q. Lebron, Danielle Marvell, Chandra Morgan, Nita Patel, Jennifer Pinto, Sana S. Siddique, Janet Sprague, Taygan Yilmaz, H. Nida Sen, Michael Bono, Denise Cunningham, Darryl Hayes, Dessie Koutsandreas, Robert B. Nussenblatt, Patti R. Sherry, Gregory L. Short, Wendy Smith, Alana Temple, Allison Bamji, Hanna Coleman, Geetaniali Davuluri, Lisa Faia, Chloe Gottlieb, Guy V. Jirawuthiworavong, Julie C. Lew, Richard Mercer, Dominic Obiyor, Cheryl H. Perry, Natalia Potapova, Eric Weichel, Keith J. Wroblewski, Paul A. Latkany, Corinne Coonan, Andrea Honda, Monica Lorenzo-Latkany, Robert Masini, Susan Morell, Angela Nguyen, Jason Badamo, Kenneth M. Boyd, Matthew Enos, Jenny Gallardo, Jacek Jarczynski, Ji Yun Lee, Mirjana McGrosky, Ann Nour, Meredith Sanchez, Kate Steinberg, Richard J. Stawell, Lisa Breayley, Carly D'Sylva, Elizabeth Glatz, Lauren Hodgson, Lyndell Lim, Cecilia Ling, Rachel McIntosh, Julie Morrison (Ewing), Andrew Newton, Sutha Sanmugasundram, Richard Smallwood, Ehud Zamir, Nicola Hunt, Lisa Jones, Ignatios Koukouras, Suzanne Williams, Pauline T. Merrill, Danielle Carns, Len Richine, Denise L. Voskuil-Marre, Kisung Woo, Bruce Gaynes, Christina Giannoulis, Pam Hulvey, Elaine Kernbauer, Heena S. Khan, Sarah J. Levine, Scott Toennessen, Eileen Tonner, Robert C. Wang, Hank Aguado, Sally Arceneaux, Karen Duignan, Gary E. Fish, Nick Hesse, Diana Jaramillo, Michael Mackens, Jean Arnwine, David Callanan, Kimberly Cummings, Keith Gray, Susie Howden, Karin Mutz, Brenda Sanchez, Susan Lightman, Filis Ismetova, Ashley Prytherch, Sophie Seguin-Greenstein, Oren Tomkins, Asat Bar, Kate Edwards, Lavanish Joshi, Jiten Moraji, Ahmed Samy, Timothy Stubbs, Simon Taylor, Hamish Towler, Rebecca Tronnberg, Gary N. Holland, Robert D. Almanzor, Jose Castellanos, Jean Pierre Hubschman, Ann K. Johiro, Alla Kukuyev, Ralph D. Levinson, Colin A. McCannel, Susan S. Ransome, Christine R. Gonzales, Anurag Gupta, Partho S. Kalyani, Michael A. Kapamajian, Peter J. Kappel, Cheryl Arcinue, Janne Chuang, Giulio Barteselli, Glenn Currie, Veronica Mendoza, Debbie Powell, Tom Clark, Denine E. Cochran, William R. Freeman, Joshua Hedaya, Tiara Kemper, Igor Kozak, Jacqueline M. LeMoine, Megan E. Loughran, Luzandra Magana, Francesca Mojana, Victoria Morrison, Vivian Nguyen, Stephen F. Oster, Nisha Acharya, David Clay, Salena Lee, Mary Lew, Todd P. Margolis, Jay Stewart, Ira G. Wong, Debra Brown, Claire M. Khouri, Debra A. Goldstein, Andrea Birnbaum, Andrea Degillio, Gemma De la Rosa, Carmen Ramirez, Evica Simjanowski, Mariner Skelly, Anna L. Castro-Malek, Catherine E. Crooke, Melody Huntley, Katrina Nash, Marcia Niec, Dimitry Pyatetsky, Misel Ramirez, Zuzanna Rozenbajgier, Howard H. Tessler, Thomas A. Albini, Marie Chin, Daniela Castaño, Ariana Elizondo, Macy Ho, Jaclyn L. Kovach, Richard C-S. Lin, Efrem Mandelcorn, Jackie K-D. Nguyen, Aura Pacini, Susan Pineda, David A. Pinto, Jose Rebimbas, Kimberly E. Stepien, Claudia Teran, Susan G. Elner, Hillary Bernard, Linda Fournier, Lindsay Godsey, Linda Goings, Richard Hackel, Moella Hesselgrave, K. Thiran Jayasundera, Robert Prusak, Pamela Titus, Melissa Bergeron, Reneé Blosser, Rebecca Brown, Carrie Chrisman-McClure, Julie R. Gothrup, Stephen J. Saxe, Deanna Sizemore, John H. Kempen, James Berger, Sheri Drossner, Joan C. DuPont, Albert M. Maguire, Janice Petner, Stephanie Engelhard, Tim Hopkins, Dawn McCall, Monique McRay, Daniel Will, Wei Xu, Jonathan Lo, Rebecca Salvo, Elizabeth Windsor, Laurel Weeney, Peter R. Pavan, Ken Albritton, JoAnn Leto, Brian Madow, Lori Mayor, Scott E. Pautler, Wyatt Saxon, Judy Soto, Burton Goldstein, Amy Klukoff, Lucy Lambright, Kim McDonald, Maria Ortiz, Susan Scymanky, Dee Dee Szalay, Narsing Rao, Tamara Davis, Jackie Douglass, Judith Linton, Margaret Padilla, Sylvia Ramos, Alexia Aguirre, Lawrence Chong, Lupe Cisneros, Elizabeth Corona, Dean Eliott, Amani Fawzi, Jesse Garcia, Rahul Khurana, Jennifer Lim, Rachel Mead, Julie H. Tsai, Albert Vitale, Paul S. Bernstein, Bonnie Carlstrom, James Gilman, Sandra Hanseen, Paula Morris, Diana Ramirez, Kimberley Wegner, John D. Sheppard, Brianne Anthony, Amber Casper, Lisa Felix-Kent, Jeanette Fernandez, Tari Johnson, Stephen V. Scoper, R. Denise Cole, Nancy Crawford, Lisa Franklin, Krista Hamelin, Jen Martin, Rebecca Marx, Gregory Schultz, Joseph Webb, Pamela Yeager, Rosa Y. Kim, Matthew S. Benz, David M. Brown, Eric Chen, Richard H. Fish, Eric Kegley, Laura Shawver, Tien P. Wong, Rebecca De La Garza, Shayla Friday (Hay), P. Kumar Rao, Eve Adcock, Rajendra S. Apte, Amy Baladenski, Rhonda Curtis, Sarah Gould, Amanda Hebden, Jamie Kambarian, Charla Meyer, Sam Pistorius, Melanie Quinn, Greg Rathert, Kevin J. Blinder, Ashley Hartz, Pam Light, Gaurav K. Shah, Russell VanGelder, Michael M. Altaweel, Natalie Kurinij, Diane Brown, Nancy Prusakowski, Larry Hubbard, Janet Wittes, William E. Barlow, Marc Hochberg, Alice T. Lyon, Alan G. Palestine, Lee S. Simon, James T. Rosenbaum, Harmon Smith, Janet Davis, Jennifer Thorne, Nisha R. Acharya, Jeffrey A. Boring, Judith Alexander, Wai Ping Ng, David S. Friedman, Anna Adler, Alyce Burke, Joanne Katz, Susan Reed, Husam Ansari, Nicholas Cohen, Sanjukta Modak, Lea T. Drye, Mark L. Van Natta, Kevin Frick, Thomas A. Louis, David Shade, Karen Pascual, Jill S. Slutsky-Sanon, Colby Glomp, Melissa A. Nieves, Maria Stevens, Amanda Allen, Yasmin Hilal, Francis Abreu, Anne Shanklin Casper, Cathleen Ewing, Adante Hart, Andrea Lears, Shirley Li, Jill Meinert, Vinnette Morrison, Deborah Nowakowski, Girlie Reyes, Dave M. Shade, Jacqueline Smith, Karen Steuernagle, Mark Van Natta, Vidya Venugopal, Tsung Yu, Paul Chen, Karen Collins, John Dodge, Kevin D. Frick, Rosetta Jackson, Christian Jimenez, Ariel Landers, Hope Livingston, Curtis L. Meinert, Sobharani Rayapudi, Weijiang Shen, Charles Shiflett, Rochelle Smith, Ada Tieman, James A. Tonascia, Richard Zheng, James Allan, Wendy K. Benz, Amitha Domalpally, Kristine A. Johnson, Dawn J. Myers, Jeong Won Pak, James L. Reimers, Debra J. Christianson, Geoffrey Chambers, Margaret A. Fleischli, Jacquelyn Freund, Kathleen E. Glander, Anne Goulding, Vonnie Gama, Sapna Gangaputra, Dennis Hafford, Susan E. Harris, Larry D. Hubbard, Jeffrey M. Joyce, Christina N. Kruse, Lauren Nagle, Amy Remm, Gwyn E. Padden-Lechten, Alyson Pohlman, Ruth A. Shaw, Peggy Sivesind, Dennis Thayer, Erika Treichel, Kelly J. Warren, Sheila M. Watson, Mary K. Webster, James K. White, Tara Wilhelmson, and Grace Zhang
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Adult ,Male ,Reoperation ,medicine.medical_specialty ,Time Factors ,Dissociation (neuropsychology) ,Visual acuity ,Adolescent ,genetic structures ,Visual Acuity ,Article ,law.invention ,Uveitis ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Foreign-Body Migration ,Randomized controlled trial ,Fluocinolone acetonide ,Risk Factors ,law ,medicine ,Humans ,Glucocorticoids ,Aged ,Aged, 80 and over ,Drug Implants ,business.industry ,030503 health policy & services ,Middle Aged ,medicine.disease ,Confidence interval ,Surgery ,Ophthalmology ,Steroid therapy ,Fluocinolone Acetonide ,Anesthesia ,Intravitreal Injections ,030221 ophthalmology & optometry ,Equipment Failure ,Female ,Implant ,medicine.symptom ,0305 other medical science ,business ,Follow-Up Studies ,medicine.drug - Abstract
To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial.Randomized clinical trial with extended follow-up.Review of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related.A total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5-9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%-9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%-48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P.001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment.There is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.
- Published
- 2016