@article{774275f7693f4ed596e03e78b03f788f,
title = "Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study",
abstract = "Purpose: To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial. Design: Randomized clinical trial with extended follow-up. Methods: 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. Results: 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. Conclusion: 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.",
author = "{Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group} and Holbrook, {Janet T.} and Sugar, {Elizabeth A.} and Burke, {Alyce E.} and Vitale, {Albert T.} and Thorne, {Jennifer E.} and Davis, {Janet L.} and Jabs, {Douglas A.} and Jaffe, {Glenn J.} and Brenda Branchaud and Paul Hahn and Larry Koreen and Lad, {Eleonora (Nora) M.} and Phoebe Lin and Martel, {Joseph Nissim} and {(Shah) Serrano}, Neha and Cindy Skalak and Lejla Vajzovic and Claxton Baer and Joyce Bryant and Sai Chavala and Michael Cusick and Shelley Day and Pouya Dayani and Justis Ehlers and Muge Kesen and Annie Lee and Alex Melamud and Qureshi, {Jawad A.} and Scott, {Adrienne Williams} and See, {Robert F.} and Shuler, {Robert K.} and Megan Wood and Steven Yeh and Alcides Fernandes and Deborah Gibbs and Donna Leef and Martin, {Daniel F.} and Sunil Srivastava and Dunn, {James P.} and Hosne Begum and Boring, {Jeffrey A.} and Brotherson, {Kristen L.} and Bryn Burkholder and Butler, {Nicholas J.} and Dennis Cain and Cook, {Mary A.} and David Emmert and Graul, {Janis R.} and Mark Herring and Rosenbaum, {James T.}",
note = "Funding Information: Funding/Support: Supported by collaborative agreements U10 EY 014655 to the Icahn School of Medicine at Mount Sinai, New York, New York (Douglas A. Jabs), U10 EY 014660 to the Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland (Janet T. Holbrook), and U10 EY 014656 to the University of Wisconsin, Madison, School of Medicine and Public Health, Madison Wisconsin (Dr. Michael M. Altaweel) from the National Eye Institute, National Institutes of Health, Bethesda, Maryland. Bausch and Lomb, Inc (Bridgewater, New Jersey) provided a limited number of fluocinolone acetonide implants to the trial for use at centers without access to implants. Financial disclosures: Albert T. Vitale (Aclont, consultant); Jennifer E. Thorne (AbbVie and Xoma, medical advisory boards; Gilead, consultant; Allergan, Inc, grant support); and Douglas A. Jabs (Applied Genetic Technologies, Data and Safety Monitoring Committee; Santen, Inc, consultant). The following authors have no financial disclosures: Janet T. Holbrook, Elizabeth A. Sugar, Alyce E. Burke, and Janet L. Davis. Publisher Copyright: {\textcopyright} 2016 Elsevier Inc.",
year = "2016",
month = apr,
day = "1",
doi = "10.1016/j.ajo.2015.12.028",
language = "English (US)",
volume = "164",
pages = "29--36",
journal = "American journal of ophthalmology",
issn = "0002-9394",
publisher = "Elsevier USA",
}