Table 1.

Patient inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Males or non-pregnant females ≥6 years	Allergy to FA or any component of the delivery system
One or both eyes must have	History of iritis only; no vitreous cells or haze
History of recurrent NIPU of ≥1 year requiring either	Infectious uveitis or vitreous hemorrhage
Systemic steroid therapy/equivalent for ≥3 months, or	Toxoplasmosis scar/retinal detachment
≥ 2 sub-Tenon steroid injections during the 6 months prior to enrollment, or	Ocular media opacity
≥2 recurrences that require systemic or sub-Tenon injection steroid therapy within the 6 months prior to enrollment	History/presence of uncontrolled IOP while receiving steroid therapy resulting in vision loss, or IOP >25 mm Hg requiring ≥2 anti-glaucoma medications
The eye randomized to undergo implantation must have had	Ocular surgery within 3 months of enrollment
≤10 anterior chamber cells and vitreous haze less than grade 2 (treatment to attain these criteria was allowed)	Need for chronic systemic steroids (>15 mg prednisolone/day) or systemic immunosuppressive therapy for nonocular disease
Visual acuity of ≥1.4 logMAR in the implanted eye	Positive HIV test
Ability to understand and sign the informed consent form
	Patients for whom risk outweighs study benefits according to the physician
	Current enrollment in another study or participation within 1 month before entry into this study

FA fluocinolone acetonide, HIV human immunodeficiency virus, IOP intraocular pressure, logMAR logarithm of the minimum angle resolution, NIPU noninfectious posterior segment uveitis