title: Risk of elevated intraocular pressure and glaucoma in patients with uveitis: results of the multicenter uveitis steroid treatment trial.
abstract: OBJECTIVE
  To report the 2-year incidence of raised intraocular pressure (IOP) and glaucomatous optic nerve damage in patients with uveitis randomized to either fluocinolone acetonide (FA) implants or systemic therapy. Secondarily, we sought to explore patient and eye characteristics associated with IOP elevation or nerve damage.
  
  
  METHODS
  A randomized, partially masked trial in which patients were randomized to either FA implants or systemic therapy.
  
  
  METHODS
  Patients aged ≥ 13 years with noninfectious intermediate, posterior, or panuveitis active within the prior 60 days for which systemic corticosteroids were indicated were eligible.
  
  
  METHODS
  Visual fields were obtained at baseline and every 12 months using the Humphrey 24-2 Swedish interactive threshold algorithm (SITA) fast protocol. Stereoscopic optic nerve photos were taken at baseline and at 3-, 6-, 12-, and 24-month follow-up visits. Masked examiners measured IOP at every study visit.
  
  
  METHODS
  Glaucoma was diagnosed based on an increase in optic nerve cup-to-disc ratio with visual field worsening or increased cup-to-disc ratio alone, for cases where visual field change was not evaluable, because of missing data or severe visual field loss at baseline.
  
  
  RESULTS
  Most patients were treated as assigned; among those evaluated for glaucoma, 97% and 10% of patients assigned to implant and systemic treatment, respectively, received implants. More patients (65%) assigned to implants experienced an IOP elevation of ≥ 10 mmHg versus 24% assigned to systemic treatment (P<0.001). Similarly, 69% of patients assigned to the implant required IOP-lowering therapy versus 26% in the systemic group (P<0.001). Glaucomatous optic nerve damage developed in 23% versus 6% (P<0.001) of implant and systemic patients, respectively. In addition to treatment assignment, black race, use of IOP-lowering medications, and uveitis activity at baseline were associated with incident glaucoma (P<0.05).
  
  
  CONCLUSIONS
  Implant-assigned eyes had about a 4-fold risk of developing IOP elevation of ≥ 10 mmHg and incident glaucomatous optic neuropathy over the first 2 years compared with those assigned to systemic therapy. Central visual acuity was unaffected. Aggressive IOP monitoring with early treatment (often including early filtration surgery) is needed to avoid glaucoma when vision-threatening inflammation requires implant therapy.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Dana Center for Preventive Ophthalmology, The Johns Hopkins University School of Medicine Wilmer Eye Institute, Baltimore, Maryland, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Friedman
authors.forename: Janet T
authors.initials: JT
authors.lastname: Holbrook
authors.forename: Husam
authors.initials: H
authors.lastname: Ansari
authors.forename: Judith
authors.initials: J
authors.lastname: Alexander
authors.forename: Alyce
authors.initials: A
authors.lastname: Burke
authors.forename: Susan B
authors.initials: SB
authors.lastname: Reed
authors.forename: Joanne
authors.initials: J
authors.lastname: Katz
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Thorne
authors.forename: Susan L
authors.initials: SL
authors.lastname: Lightman
authors.forename: John H
authors.initials: JH
authors.lastname: Kempen
mesh_terms: D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000009:adverse effects*; D005901:Glaucoma / Q000139:chemically induced* / Q000503:physiopathology / Q000601:surgery; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009901:Optic Nerve Diseases / Q000139:chemically induced* / Q000503:physiopathology / Q000601:surgery; D012307:Risk Factors; D011795:Surveys and Questionnaires; D014065:Tonometry, Ocular; D014605:Uveitis / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity; D014794:Visual Fields / Q000502:physiology
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide