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Am J Ophthalmol. 2016 Apr;164:29-36. doi: 10.1016/j.ajo.2015.12.028. Epub 2015 Dec 31.

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

Collaborators (558)

Jaffe GJ, Branchaud B, Hahn P, Koreen L, Lad EN, Lin P, Martel JN, Serrano NS, Skalak C, Vajzovic L, Baer C, Bryant J, Chavala S, Cusick M, Day S, Dayani P, Ehlers J, Kesen M, Lee A, Melamud A, Qureshi JA, Scott AW, See RF, Shuler RK, Wood M, Yeh S, Fernandes A, Gibbs D, Leef D, Martin DF, Srivastava S, Dunn JP, Begum H, Boring J, Brotherson KL, Burkholder B, Butler NJ, Cain D, Cook MA, Emmert D, Graul JR, Herring M, Laing A, Leung TG, Mahon MC, Moradi A, Nwankwo A, Ostheimer TL, Reed T, Arnold E, Barnabie PM, Belair ML, Bolton SG, Brodine JB, Brown DM, Brune LM, Galor A, Gan T, Jacobowitz A, Kapoor M, Kedhar S, Kim S, Leder HA, Livingston AG, Morton Y, Nolan K, Peters GB, Soto P, Stevenson R, Tarver-Carr M, Wang Y, Foster CS, Anesi SD, Bruner L, Ceron O, Hinkle DM, Persons N, Wentworth B, Acevedo S, Anzaar F, Cesca T, Contero A, Fitzpatrick K, Goronga F, Johnson J, Lebron KQ, Marvell D, Morgan C, Patel N, Pinto J, Siddique SS, Sprague J, Yilmaz T, Sen HN, Bono M, Cunningham D, Hayes D, Koutsandreas D, Nussenblatt RB, Sherry PR, Short GL, Smith W, Temple A, Bamji A, Coleman H, Davuluri G, Faia L, Gottlieb C, Jirawuthiworavong GV, Lew JC, Mercer R, Obiyor D, Perry CH, Potapova N, Weichel E, Wroblewski KJ, Yeh S, Latkany PA, Coonan C, Honda A, Lorenzo-Latkany M, Masini R, Morell S, Nguyen A, Badamo J, Boyd KM, Enos M, Gallardo J, Jarczynski J, Lee JY, McGrosky M, Nour A, Sanchez M, Steinberg K, Stawell RJ, Breayley L, D'Sylva C, Glatz E, Hodgson L, Lim L, Ling C, McIntosh R, Morrison Ewing J, Newton A, Sanmugasundram S, Smallwood R, Zamir E, Hunt N, Jones L, Koukouras I, Williams S, Merrill PT, Carns D, Richine L, Voskuil-Marre DL, Woo K, Gaynes B, Giannoulis C, Hulvey P, Kernbauer E, Khan HS, Levine SJ, Toennessen S, Tonner E, Wang RC, Aguado H, Arceneaux S, Duignan K, Fish GE, Hesse N, Jaramillo D, Mackens M, Arnwine J, Callanan D, Cummings K, Gray K, Howden S, Mutz K, Sanchez B, Lightman S, Ismetova F, Prytherch A, Seguin-Greenstein S, Tomkins O, Bar A, Edwards K, Joshi L, Moraji J, Samy A, Stubbs T, Taylor S, Towler H, Tronnberg R, Holland GN, Almanzor RD, Castellanos J, Hubschman JP, Johiro AK, Kukuyev A, Levinson RD, McCannel CA, Ransome SS, Gonzales CR, Gupta A, Kalyani PS, Kapamajian MA, Kappel PJ, Arcinue C, Chuang J, Barteselli G, Currie G, Mendoza V, Powell D, Clark T, Cochran DE, Freeman WR, Hedaya J, Kemper T, Kozak I, LeMoine JM, Loughran ME, Magana L, Mojana F, Morrison V, Nguyen V, Oster SF, Acharya N, Clay D, Lee S, Lew M, Margolis TP, Stewart J, Wong IG, Brown D, Khouri CM, Goldstein DA, Birnbaum A, Degillio A, De la Rosa G, Ramirez C, Simjanowski E, Skelly M, Castro-Malek AL, Crooke CE, Huntley M, Nash K, Niec M, Pyatetsky D, Ramirez M, Rozenbajgier Z, Tessler HH, Davis JL, Albini TA, Chin M, Castaño D, Elizondo A, Ho M, Kovach JL, Lin RC, Mandelcorn E, Nguyen JK, Pacini A, Pineda S, Pinto DA, Rebimbas J, Stepien KE, Teran C, Elner SG, Bernard H, Fournier L, Godsey L, Goings L, Hackel R, Hesselgrave M, Jayasundera KT, Prusak R, Titus P, Bergeron M, Blosser R, Brown R, Chrisman-McClure C, Gothrup JR, Saxe SJ, Sizemore D, Kempen JH, Berger J, Drossner S, DuPont JC, Maguire AM, Petner J, Engelhard S, Hopkins T, McCall D, McRay M, Will D, Xu W, Lo J, Salvo R, Windsor E, Weeney L, Pavan PR, Albritton K, Leto J, Madow B, Mayor L, Pautler SE, Saxon W, Soto J, Goldstein B, Klukoff A, Lambright L, McDonald K, Ortiz M, Scymanky S, Szalay DD, Rao N, Davis T, Douglass J, Linton J, Padilla M, Ramos S, Aguirre A, Chong L, Cisneros L, Corona E, Eliott D, Fawzi A, Garcia J, Khurana R, Lim J, Mead R, Tsai JH, Vitale A, Bernstein PS, Carlstrom B, Gilman J, Hanseen S, Morris P, Ramirez D, Wegner K, Sheppard JD, Anthony B, Casper A, Felix-Kent L, Fernandez J, Johnson T, Scoper SV, Cole RD, Crawford N, Franklin L, Hamelin K, Martin J, Marx R, Schultz G, Webb J, Yeager P, Kim RY, Benz MS, Brown DM, Chen E, Fish RH, Kegley E, Shawver L, Wong TP, De La Garza R, Friday Hay S, Mutz K, Rao PK, Adcock E, Apte RS, Baladenski A, Curtis R, Gould S, Hebden A, Kambarian J, Meyer C, Pistorius S, Quinn M, Rathert G, Blinder KJ, Hartz A, Light P, Shah GK, VanGelder R, Jabs DA, Altaweel MM, Holbrook J, Kempen JH, Kurinij N, Jabs DA, Almanzor RD, Altaweel MM, Brown D, Dunn JP, Holbrook JT, Holland GN, Kempen JH, Kim RY, Kurinij N, Prusakowski N, Thorne JE, Bolton SG, Brune LM, Clark T, Gilman J, Hubbard L, Martin DF, Nussenblatt RB, Wittes J, Barlow WE, Hochberg M, Lyon AT, Palestine AG, Simon LS, Altaweel MM, Holbrook JT, Jabs DA, Kurinij N, Rosenbaum JT, Smith H, Kempen JH, Jaffe GJ, Davis J, Dunn JP, Martin DF, Thorne J, Vitale A, Thorne JE, Acharya NR, Jabs DA, Kempen JH, Latkany PA, Vitale AT, Nussenblatt RB, VanGelder R, Almanzor RD, Boring JA, Gibbs D, Lee S, Prusakowski N, Thorne JE, Alexander J, Ng WP, Friedman DS, Adler A, Alexander J, Burke A, Holbrook JT, Katz J, Kempen JH, Prusakowski N, Reed S, Thorne JE, Ansari H, Cohen N, Modak S, Ng WP, Sugar EA, Burke AE, Drye LT, Holbrook JT, Van Natta ML, Frick K, Katz J, Louis TA, Modak S, Shade D, Jabs DA, Pascual K, Slutsky-Sanon JS, Glomp C, Nieves MA, Stevens M, Allen A, Hilal Y, Holbrook JT, Abreu F, Burke A, Casper AS, Drye LT, Ewing C, Friedman DS, Hart A, Lears A, Li S, Meinert J, Morrison V, Nowakowski D, Prusakowski N, Reyes G, Shade DM, Smith J, Steuernagle K, Sugar EA, Thorne JE, Van Natta M, Venugopal V, Yu T, Adler A, Alexander J, Boring J, Chen P, Cohen N, Collins K, Dodge J, Frick KD, Jackson R, Jimenez C, Katz J, Landers A, Livingston H, Louis TA, Meinert CL, Modak S, Ng WP, Rayapudi S, Shen W, Shiflett C, Smith R, Tieman A, Tonascia JA, Zheng R, Altaweel MM, Allan J, Benz WK, Domalpally A, Johnson KA, Myers DJ, Pak JW, Reed S, Reimers JL, Christianson DJ, Chambers G, Fleischli MA, Freund J, Glander KE, Goulding A, Gama V, Gangaputra S, Hafford D, Harris SE, Hubbard LD, Joyce JM, Kruse CN, Nagle L, Remm A, Padden-Lechten GE, Pohlman A, Shaw RA, Sivesind P, Thayer D, Treichel E, Warren KJ, Watson SM, Webster MK, White JK, Wilhelmson T, Zhang G.

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.

PMID:
26748056
PMCID:
PMC4811688
DOI:
10.1016/j.ajo.2015.12.028
[Indexed for MEDLINE]
Free PMC Article

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