Dissociations of the XXXX Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.

@entity1 @entity1596 @entity20773
PURPOSE: To describe @entity20773 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 @entity1 . Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically-related. RESULTS: 250 eyes (146 @entity1 ) had at least one implant placed. Median time follow-up time after implant placement was 6 years (range 0.5 to 9.2). Thirty-four dissociations were reported in 30 @entity1 . There were 22 spontaneous events in 22 @entity1 ; 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. 39 implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 @entity1 (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 < 0.001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of @entity1596 or it's treatment. CONCLUSION: There is an increasing risk of dissociation of Retisert implants during follow-up, the risk is greater with removal/exchange surgeries, but both the risk of spontaneous and surgically related events increase 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 @entity1596 for years, this rate is not unexpected.
