title: Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.
abstract: OBJECTIVE
  To describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Janet T
authors.initials: JT
authors.lastname: Holbrook
authors.affiliation: 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.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Sugar
authors.affiliation: Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Alyce E
authors.initials: AE
authors.lastname: Burke
authors.affiliation: Moran Eye Center and Department of Ophthalmology, University of Utah School of Medicine, Salt Lake City, Utah.
authors.forename: Albert T
authors.initials: AT
authors.lastname: Vitale
authors.affiliation: 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.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Thorne
authors.affiliation: Bascom Palmer Eye Institute and Department of Ophthalmology, University of Miami School of Medicine, Miami, Florida.
authors.forename: Janet L
authors.initials: JL
authors.lastname: Davis
authors.affiliation: 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.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Jabs
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004343:Drug Implants / Q000009:adverse effects*; D004868:Equipment Failure; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000009:adverse effects*; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000175:diagnosis / Q000209:etiology* / Q000601:surgery; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D012086:Reoperation; D012307:Risk Factors; D013997:Time Factors; D014605:Uveitis / Q000188:drug therapy*; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide