title: The idiopathic intracranial hypertension treatment trial: clinical profile at baseline.
abstract: OBJECTIVE
  To our knowledge, there are no large prospective cohorts of untreated patients with idiopathic intracranial hypertension (IIH) to characterize the disease.
  
  
  OBJECTIVE
  To report the baseline clinical and laboratory features of patients enrolled in the Idiopathic Intracranial Hypertension Treatment Trial.
  
  
  METHODS
  We collected data at baseline from questionnaires, examinations, automated perimetry, and fundus photography grading. Patients (n = 165) were enrolled from March 17, 2010, to November 27, 2012, at 38 academic and private practice sites in North America. All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation between -2 dB and -7 dB. All but 4 participants were women.
  
  
  METHODS
  Baseline and laboratory characteristics.
  
  
  RESULTS
  The mean (SD) age of our patients was 29.0 (7.4) years and 4 (2.4%) were men. The average (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 39.9 (8.3). Headache was the most common symptom (84%). Transient visual obscurations occurred in 68% of patients, back pain in 53%, and pulse synchronous tinnitus in 52%. Only 32% reported visual loss. The average (SD) perimetric mean deviation in the worst eye was -3.5 (1.1) dB, (range, -2.0 to -6.4 dB) and in the best eye was -2.3 (1.1) dB (range, -5.2 to 0.8 dB). A partial arcuate visual field defect with an enlarged blind spot was the most common perimetric finding. Visual acuity was 85 letters or better (20/20) in 71% of the worst eyes and 77% of the best eyes. Quality of life measures, including the National Eye Institute Visual Function Questionnaire-25 and the Short Form-36 physical and mental health summary scales, were lower compared with population norms.
  
  
  CONCLUSIONS
  The Idiopathic Intracranial Hypertension Treatment Trial represents the largest prospectively analyzed cohort of untreated patients with IIH. Our data show that IIH is almost exclusively a disease of obese young women. Patients with IIH with mild visual loss have typical symptoms, may have mild acuity loss, and have visual field defects, with predominantly arcuate loss and enlarged blind spots that require formal perimetry for detection.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01003639.
authors.affiliation: Department of Neurology, University of Iowa, Iowa City2Department of Ophthalmology, University of Iowa, Iowa City.
authors.forename: Michael
authors.initials: M
authors.lastname: Wall
authors.affiliation: Roosevelt Hospital, New York, New York4New York Eye and Ear Infirmary, New York, New York.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Kupersmith
authors.affiliation: Center for Human Experimental Therapeutics, University of Rochester, Rochester, New York.
authors.forename: Karl D
authors.initials: KD
authors.lastname: Kieburtz
authors.affiliation: Department of Neurology, University of Mississippi, Jackson7Department of Ophthalmology, University of Mississippi, Jackson.
authors.forename: James J
authors.initials: JJ
authors.lastname: Corbett
authors.affiliation: Department of Ophthalmology, University of Rochester, Rochester, New York.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Feldon
authors.affiliation: Department of Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas10Department of Neurology, University of Texas Southwestern Medical Center, Dallas.
authors.forename: Deborah I
authors.initials: DI
authors.lastname: Friedman
authors.affiliation: Bethesda Neurology, Bethesda, Maryland.
authors.forename: David M
authors.initials: DM
authors.lastname: Katz
authors.affiliation: Department of Ophthalmology, University of California-Davis.
authors.forename: John L
authors.initials: JL
authors.lastname: Keltner
authors.affiliation: Division of Extramural Research, National Eye Institute, Bethesda, Maryland.
authors.forename: Eleanor B
authors.initials: EB
authors.lastname: Schron
authors.affiliation: Center for Human Experimental Therapeutics, University of Rochester, Rochester, New York14Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York.
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
mesh_terms: D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D005260:Female; D006801:Humans; D019586:Intracranial Hypertension / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012737:Sex Factors; D011795:Surveys and Questionnaires; D014786:Vision Disorders / Q000150:complications / Q000503:physiopathology / Q000628:therapy; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
references.citation: J Womens Health (Larchmt). 2009 Mar;18(3):303-10
references.pmid: 19243271
references.citation: J Neuroophthalmol. 2011 Dec;31(4):310-5
references.pmid: 21799447
references.citation: J Neuroophthalmol. 2014 Jun;34(2):107-17
references.pmid: 24739993
references.citation: Acta Neurol Scand. 2007 Nov;116(5):322-7
references.pmid: 17922725
references.citation: Ann Neurol. 1984 Oct;16(4):489-94
references.pmid: 6497356
references.citation: Invest Ophthalmol Vis Sci. 1998 Jan;39(1):134-42
references.pmid: 9430554
references.citation: Ann Intern Med. 1999 Oct 5;131(7):485-91
references.pmid: 10507956
references.citation: Arch Neurol. 1988 Aug;45(8):875-7
references.pmid: 3395261
references.citation: J Neurol Neurosurg Psychiatry. 1982 Jan;45(1):13-8
references.pmid: 7062066
references.citation: Arch Neurol. 1982 Aug;39(8):461-74
references.pmid: 7103794
references.citation: Am J Ophthalmol. 1988 Mar 15;105(3):261-5
references.pmid: 3344783
references.citation: JAMA. 2014 Apr 23-30;311(16):1641-51
references.pmid: 24756514
references.citation: Ophthalmology. 1986 Jan;93(1):4-7
references.pmid: 3951815
references.citation: Neurology. 2003 May 13;60(9):1418-24
references.pmid: 12743224
references.citation: Arch Ophthalmol. 1977 Sep;95(9):1553-65
references.pmid: 71138
references.citation: AMA Arch Neurol Psychiatry. 1952 Jul;68(1):130-49
references.pmid: 14932554
references.citation: Eye (Lond). 1998;12 ( Pt 1):111-8
references.pmid: 9614526
references.citation: Qual Life Res. 2003 Dec;12(8):963-74
references.pmid: 14651415
references.citation: J Child Neurol. 1992 Apr;7(2):196-8
references.pmid: 1573238
references.citation: J Clin Neuroophthalmol. 1985 Mar;5(1):55-6
references.pmid: 3156890
references.citation: Brain. 1991 Feb;114 ( Pt 1A):155-80
references.pmid: 1998880
references.citation: Neurology. 2000 Jan 25;54(2):319-24
references.pmid: 10668690
references.citation: Am J Ophthalmol. 2006 Dec;142(6):1026-35
references.pmid: 17046704
references.citation: Expert Rev Neurother. 2008 Mar;8(3):397-407
references.pmid: 18345970
references.citation: Am J Ophthalmol. 2007 Apr;143(4):635-41
references.pmid: 17386271
references.citation: Brain. 1974 Jun;97(2):301-12
references.pmid: 4434179
references.citation: J Neurosurg. 1982 Dec;57(6):833-6
references.pmid: 7143069
references.citation: J Neuroophthalmol. 2011 Dec;31(4):316-9
references.pmid: 21537196
references.citation: J Neuroophthalmol. 2008 Dec;28(4):337-47
references.pmid: 19145137
references.citation: Optom Vis Sci. 1995 Mar;72(3):186-91
references.pmid: 7609941
references.citation: Arch Ophthalmol. 2010 Jun;128(6):705-11
references.pmid: 20547947
references.citation: Laryngoscope. 1987 Aug;97(S42):1-17
references.pmid: 3302575
references.citation: Arch Ophthalmol. 1998 Nov;116(11):1496-504
references.pmid: 9823352
references.citation: J Neurosurg. 1978 Aug;49(2):256-63
references.pmid: 671078
references.citation: Qual Life Res. 2003 Dec;12(8):981-1002
references.pmid: 14651417
references.citation: Cephalalgia. 1990 Dec;10(6):331-5
references.pmid: 2289234
references.citation: Curr Neurol Neurosci Rep. 2012 Jun;12(3):334-9
references.pmid: 22354546
references.citation: Neurology. 2002 May 28;58(10):1551-3
references.pmid: 12034799
references.citation: J Neurol Neurosurg Psychiatry. 1976 May;39(5):420-3
references.pmid: 932759
references.citation: Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003434
references.pmid: 16034899