TY - JOUR
T1 - Dissociations of the Fluocinolone Acetonide Implant
T2 - The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study
AU - Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group
AU - Holbrook, Janet T.
AU - Sugar, Elizabeth A.
AU - Burke, Alyce E.
AU - Vitale, Albert T.
AU - Thorne, Jennifer E.
AU - Davis, Janet L.
AU - Jabs, Douglas A.
AU - Jaffe, Glenn J.
AU - Branchaud, Brenda
AU - Hahn, Paul
AU - Koreen, Larry
AU - Lad, Eleonora (Nora) M.
AU - Lin, Phoebe
AU - Martel, Joseph Nissim
AU - (Shah) Serrano, Neha
AU - Skalak, Cindy
AU - Vajzovic, Lejla
AU - Baer, Claxton
AU - Bryant, Joyce
AU - Chavala, Sai
AU - Cusick, Michael
AU - Day, Shelley
AU - Dayani, Pouya
AU - Ehlers, Justis
AU - Kesen, Muge
AU - Lee, Annie
AU - Melamud, Alex
AU - Qureshi, Jawad A.
AU - Scott, Adrienne Williams
AU - See, Robert F.
AU - Shuler, Robert K.
AU - Wood, Megan
AU - Yeh, Steven
AU - Fernandes, Alcides
AU - Gibbs, Deborah
AU - Leef, Donna
AU - Martin, Daniel F.
AU - Srivastava, Sunil
AU - Dunn, James P.
AU - Begum, Hosne
AU - Boring, Jeffrey A.
AU - Brotherson, Kristen L.
AU - Burkholder, Bryn
AU - Butler, Nicholas J.
AU - Cain, Dennis
AU - Cook, Mary A.
AU - Emmert, David
AU - Graul, Janis R.
AU - Herring, Mark
AU - Yu, Tsung
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/4/1
Y1 - 2016/4/1
N2 - 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.
AB - 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.
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U2 - 10.1016/j.ajo.2015.12.028
DO - 10.1016/j.ajo.2015.12.028
M3 - Article
C2 - 26748056
AN - SCOPUS:84990189272
SN - 0002-9394
VL - 164
SP - 29
EP - 36
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
ER -