title: SAFETY OF INTRAVITREAL DEXAMETHASONE IMPLANT (OZURDEX): The SAFODEX study. Incidence and Risk Factors of Ocular Hypertension.
abstract: OBJECTIVE
  To analyze the incidence, risk factors, and time course of intraocular pressure elevation after intravitreal dexamethasone implant (Ozurdex).
  
  
  METHODS
  The medical charts of 421 consecutive eyes (361 patients) receiving one or more Ozurdex implant between October 2010 and February 2015 were reviewed retrospectively. Ocular hypertension was defined as intraocular pressure of at least 25 mmHg or an increase of at least 10 mmHg from baseline. The main indications for treatment were retinal vein occlusion (34%), diabetic macular edema (30%), postsurgical macular edema (17%), uveitis (14%), and other etiologies (5%).
  
  
  RESULTS
  Among 1,000 intravitreal injections, ocular hypertension was recorded for 28.5% of injected eyes over a mean follow-up period of 16.8 months (3-55). Intraocular pressure-lowering medication was required for 31% of eyes. Only three eyes with preexisting glaucoma required filtering surgery to manage postinjection intraocular pressure elevation. Early retreatment between the third and fourth month does not increase the risk of intraocular pressure elevation. Younger age, male sex, Type 1 diabetes, preexisting glaucoma treated with dual or triple therapy, and a history of retinal vein occlusion or uveitis were significant risk factors for ocular hypertension after dexamethasone implant injection (P < 0.05 for all the above).
  
  
  CONCLUSIONS
  Episodes of ocular hypertension after Ozurdex implant were generally transient and successfully managed with topical treatment. An analysis of the risk factors may help to determine the risk-benefit ratio for individual patients treated with dexamethasone implants.
authors: *Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, UMR-CNRS 5510 Matéis, University of Medicine Lyon 1, Lyon, France; †Department of Ophthalmology, Desgenettes Military Hospital, Lyon, France; and ‡French Military Health Service Academy, Val de Grâce, Paris, France.
authors: Ariane
authors: A
authors: Malclès
authors: Corinne
authors: C
authors: Dot
authors: Nicolas
authors: N
authors: Voirin
authors: Anne-Laure
authors: AL
authors: Vié
authors: Émilie
authors: É
authors: Agard
authors: David
authors: D
authors: Bellocq
authors: Philippe
authors: P
authors: Denis
authors: Laurent
authors: L
authors: Kodjikian
mesh_terms: D003907:Dexamethasone / Q000008:administration & dosage*; D004343:Drug Implants; D005260:Female; D005602:France / Q000453:epidemiology; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D015994:Incidence; D007429:Intraocular Pressure / Q000187:drug effects*; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy; D008297:Male; D009798:Ocular Hypertension / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D012189:Retrospective Studies; D041623:Tomography, Optical Coherence; D014792:Visual Acuity
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D003907:Dexamethasone