Janet T Holbrook1, Elizabeth A Sugar2, Alyce E Burke1, Albert T Vitale3, Jennifer E Thorne4, Janet L Davis5, Douglas A Jabs6. 1. Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland. 2. Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Department of Biostatistics, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland. 3. Moran Eye Center and Department of Ophthalmology, University of Utah School of Medicine, Salt Lake City, Utah. 4. Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Wilmer Eye Institute and the Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland. 5. Bascom Palmer Eye Institute and Department of Ophthalmology, University of Miami School of Medicine, Miami, Florida. 6. Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Departments of Ophthalmology and Medicine, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: douglas.jabs@mssm.edu.
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.
RCT Entities:
PURPOSE: To describe fluocinolone acetonide implant dissociations in the Multicenter UveitisSteroid 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.
Authors: John H Kempen; Michael M Altaweel; Janet T Holbrook; Douglas A Jabs; Elizabeth A Sugar Journal: Am J Ophthalmol Date: 2010-01-25 Impact factor: 5.258
Authors: Benjamin P Nicholson; Rishi P Singh; Jonathan E Sears; Careen Y Lowder; Peter K Kaiser Journal: Am J Ophthalmol Date: 2012-09-13 Impact factor: 5.258
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