Dissociations of the fluocinolone acetonide implant: experience from long-term follow-up during the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study

Abstract

Purpose : To quantify the long-term risk of spontaneous and surgical dissociations for the 250 eyes receiving a fluocinolone acetonide implant during the Multicenter Uveitis Steroid Treatment Trial and Follow-up Study.

Methods : Dissociation was defined as the separation of the drug pellet from the strut and classified as spontaneous or surgical if identified during clinical observation or surgery, respectively. Demographic and clinical data immediately prior to implant were collected along with surgical details. Visual acuity was measured using logarithmic (ETDRS) visual acuity charts.

Results : Sixty-three dissociations were reported with 61 (42 spontaneous and 19 surgical) initial implantation. The 9-year cumulative proportion with spontaneous dissociation was 33.7% (95% confidence interval [CI]: 22.7%-43.1%, Figure 1). Eyes with a vitrectomy during implant placement were at higher risk for spontaneous dissociation (Harzard ratio: 3.1, p = 0.033). Nineteen eyes (23.2%, 95% CI: 13.8%-32.5%) had a surgical dissociation. Time since implantation (per year Adjusted Odds Ratio [aOR]: 1.66, p = 0.003) was associated with increased risk of surgical dissociation. Just over a quarter of eyes reported meaningful vision loss (≥ 15 letters) among both the spontaneous and surgical dissociations.

Conclusions : The risk of spontaneous and surgical dissociation increases substantially the longer the implant remains in the eye. Given the potential for substantial vision loss that may not be recoverable, if replacement is needed then the data suggest that the original implant be removed as the new implant is placed.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Figure 1. Kaplan-Meier estimate of time to spontaneous dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. The black line represents the estimate with the 95% confidence interval boundaries in grey.