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Jennifer E Thorne, Elizabeth Sugar, Alyce Burke, Albert T Vitale, Douglas A Jabs, Janet T. Holbrook, ; Dissociations of fluocinolone acetonide implants in the MUST study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3108.
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To describe the types and risks of fluocinolone acetonide (FA) implant dissociation in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.
We reviewed data from MUST Trial and Follow-up Study collected from December 2005 through November 2014 on the first implant for eyes that received FA implants as treatment for non-infectious uveitis in MUST. Dissociation was defined as FA pellet separation from its strut. Each case of dissociation was reviewed by the MUST Safety Officer.
A total of 250 eyes (146 patients) had at least one FA implant placed; the median follow-up from implantation was 5.8 years (interquartile range: 4.4-6.4). Twenty dissociations were reported for 17 individuals, three had dissociations in both eyes. Nine dissociations occurred spontaneously (identified by patient symptoms or clinical examination) and all involved a dislocated pellet. The 5-year cumulative risk of a spontaneous dissociation was 0.6% (95% confidence interval: 0-1.7%) with the earliest event occurring 4.8 years after placement. Eleven dissociations were related to an implant removal surgery (noted or occurred during surgery without prior symptoms). 31% of 36 eyes undergoing removal surgeries for the first implant had dissociated drug pellets. Time from placement to surgery was higher for the surgeries associated with dissociation as compared those not associated to dissociation (5.4 vs 3.4 years, p < 0.001).
Dissociation is a known risk factor for FA implants. In MUST, spontaneous dissociations occurred infrequently, with a cumulative 5-year risk less than 1%. The fraction of surgeries with an associated dissociation was lower in MUST than previously observed (31% vs 40%1), with implant duration again a risk factor.
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