Incidence and risk factors for glaucoma and intraocular pressure (IOP) elevation in patients treated with fluocinolone acetonide (FA) implants; results of the Multicenter Uveitis Steroid Treatment Trial (MUST)

Abstract

Purpose: : To report the two-year incidence of IOP elevations and glaucomatous optic nerve damage in patients with uveitis randomized to either FA implants or systemic therapy.

Methods: : The MUST Trial is a randomized (allocation ratio 1:1), partially masked, parallel treatment comparative effectiveness trial in which patients were randomized to either FA implants or systemic therapy. Patients 13 years of age or older who had non-infectious intermediate, posterior or panuveitis in one or both eyes active within the prior 60 days for which systemic corticosteroids were indicated were eligible. Visual fields were obtained at baseline and every twelve months using the Humphrey 24-2 SITA-fast protocol and were repeated if they were unreliable or abnormal at baseline. Optic nerve photos were taken in stereo at a nominal 30 or 35 degree angle depending on the fundus camera used at baseline and at three, six, and twelve month follow-up visits and annually thereafter. Glaucoma was diagnosed on the basis of an increase in optic nerve cup-to-disc ratio (CDR) with visual field worsening. In cases where there was no ability to detect visual field change either due to missing visual field data or severe visual field loss at baseline, optic nerve changes alone were used.

Results: : IOP elevations were common in the first year for patients assigned to implants; 59% (n=70) of patients assigned to and receiving implants experienced an elevation of at least 10 mmHg within 12 months of implant surgery as compared to 17% (20 patients) assigned to systemic treatment. Overall 65% vs 24% of patients assigned to implant vs systemic, respectively, experienced an elevation within the first two years of follow-up. Glaucomatous optic nerve damage with visual field loss developed within 24 months in 16% vs. 4% (Odds ratio (OR)=5.0, 95% CI: 2.0-12.2) of implant and systemic eyes, respectively, using an intention-to-treat analysis.

Conclusions: : Patients receiving an FA implant had nearly a five-fold risk of developing large IOP elevations over the first two years compared to those treated with medical therapy and about one in six developed glaucomatous optic neuropathy. These adverse outcomes should be weighed against the benefits of the implants when determining the ideal therapy for patients with uveitis.

Clinical Trial: : http://www.clinicaltrials.gov NCT00132691

Keywords: clinical (human) or epidemiologic studies: outcomes/complications • intraocular pressure