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

Publication ,  Journal Article
Holbrook, JT; Sugar, EA; Burke, AE; Vitale, AT; Thorne, JE; Davis, JL; Jabs, DA; Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group
Published in: Am J Ophthalmol
April 2016

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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Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

April 2016

Volume

164

Start / End Page

29 / 36

Location

United States

Related Subject Headings

  • Visual Acuity
  • Uveitis
  • Time Factors
  • Risk Factors
  • Reoperation
  • Postoperative Complications
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Intravitreal Injections
 

Citation

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Holbrook, J. T., Sugar, E. A., Burke, A. E., Vitale, A. T., Thorne, J. E., Davis, J. L., … Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group. (2016). Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Am J Ophthalmol, 164, 29–36. https://doi.org/10.1016/j.ajo.2015.12.028
Holbrook, Janet T., Elizabeth A. Sugar, Alyce E. Burke, Albert T. Vitale, Jennifer E. Thorne, Janet L. Davis, Douglas A. Jabs, and Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group. “Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.Am J Ophthalmol 164 (April 2016): 29–36. https://doi.org/10.1016/j.ajo.2015.12.028.
Holbrook JT, Sugar EA, Burke AE, Vitale AT, Thorne JE, Davis JL, et al. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Am J Ophthalmol. 2016 Apr;164:29–36.
Holbrook, Janet T., et al. “Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.Am J Ophthalmol, vol. 164, Apr. 2016, pp. 29–36. Pubmed, doi:10.1016/j.ajo.2015.12.028.
Holbrook JT, Sugar EA, Burke AE, Vitale AT, Thorne JE, Davis JL, Jabs DA, Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Am J Ophthalmol. 2016 Apr;164:29–36.
Journal cover image

Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

April 2016

Volume

164

Start / End Page

29 / 36

Location

United States

Related Subject Headings

  • Visual Acuity
  • Uveitis
  • Time Factors
  • Risk Factors
  • Reoperation
  • Postoperative Complications
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Intravitreal Injections