title: The Longitudinal Idiopathic Intracranial Hypertension Trial: Outcomes From Months 6-12.
abstract: OBJECTIVE
  To determine whether the beneficial effects of acetazolamide (ACZ) in improving vision at 6 months continues to month 12 in participants of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT).
  
  
  METHODS
  Nonrandomized clinical study.
  
  
  METHODS
  In the IIHTT, subjects were randomly assigned to placebo-plus-diet or maximally tolerated dosage of acetazolamide-plus-diet. At 6 months subjects transitioned from study drug to ACZ. This resulted in the following groups: (1) ACZ to ACZ; n = 34; (2) placebo to ACZ; n = 35; (3) ACZ to no treatment; n = 16; and (4) placebo to no treatment; n = 11. Ninety-six IIHTT subjects had evaluations at 6 and 12 months. Our main outcome measure was change from month 6 to month 12 in visual field mean deviation (MD) with secondary measures being change in papilledema grade, ETDRS scores, and quality-of-life (QoL) measures.
  
  
  RESULTS
  The ACZ to ACZ group improved 0.35 dB, P = .05; placebo subjects with no ACZ improved 0.81 dB MD, P = .07 at 12 months. The other groups improved 0.35-0.46 dB MD. Mean improvements in papilledema grade occurred most markedly in the group that exchanged placebo for ACZ (0.91 units, P < .001). QoL and headache disability scores showed significant improvements in the placebo group with added ACZ.
  
  
  CONCLUSIONS
  Improvements in MD continued from month 6 to month 12 of the IIHTT in all treatment groups, most marked in the placebo group tapered off study drug. Adding ACZ to the placebo group significantly improved papilledema grade, headache, and QoL measures.
authors.affiliation: Department of Neurology, University of Iowa, Iowa City, Iowa; Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa. Electronic address: michael-wall@uiowa.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Wall
authors.affiliation: Mount Sinai West and New York Eye and Ear Infirmary, New York, New York.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Kupersmith
authors.affiliation: Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Thurtell
authors.affiliation: Illinois Eye and Ear Infirmary, Chicago, Illinois.
authors.forename: Heather E
authors.initials: HE
authors.lastname: Moss
authors.affiliation: Mount Sinai West and New York Eye and Ear Infirmary, New York, New York.
authors.forename: Elizabeth Ann
authors.initials: EA
authors.lastname: Moss
authors.affiliation: Center for Human Experimental Therapeutics, University of Rochester, Rochester, New York.
authors.forename: Peggy
authors.initials: P
authors.lastname: Auinger
mesh_terms: D000086:Acetazolamide / Q000008:administration & dosage*; D000284:Administration, Oral; D000328:Adult; D002257:Carbonic Anhydrase Inhibitors / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010211:Papilledema / Q000209:etiology* / Q000503:physiopathology / Q000517:prevention & control; D011559:Pseudotumor Cerebri / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D014794:Visual Fields / Q000502:physiology*
chemical_list: D002257:Carbonic Anhydrase Inhibitors; D000086:Acetazolamide