Effect of Acetazolamide on Visual Function in Patients With Idiopathic Intracranial Hypertension and Mild Visual Loss: The Idiopathic Intracranial Hypertension Treatment Trial

IMPORTANCE Acetazolamide is commonly used to treat idiopathic intracranial hypertension (IIH), but there is insufficient information to establish an evidence base for its use. OBJECTIVE To determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction d...

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Bibliographic Details
Published in:JAMA : the journal of the American Medical Association 2014-04, Vol.311 (16), p.1641-1651
Main Authors: Wall, Michael, McDermott, Michael P, Kieburtz, Karl D, Corbett, James J, Feldon, Steven E, Friedman, Deborah I, Katz, David M, Keltner, John L, Schron, Eleanor B, Kupersmith, Mark J
Format: Article
Language:English
Subjects:
Acetazolamide - therapeutic use
Adult
Biological and medical sciences
Carbonic Anhydrase Inhibitors - therapeutic use
Clinical outcomes
Clinical trials
Combined Modality Therapy
Diet, Sodium-Restricted
Female
General aspects
Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy
Humans
Hypertension
Inhibitor drugs
Male
Medical sciences
Medical treatment
Nervous system (semeiology, syndromes)
Neurology
Ophthalmology
Pseudotumor Cerebri - complications
Pseudotumor Cerebri - diet therapy
Pseudotumor Cerebri - drug therapy
Quality of Life
Treatment Outcome
Vision disorders
Vision Disorders - drug therapy
Vision Disorders - etiology
Weight Loss
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Summary:IMPORTANCE Acetazolamide is commonly used to treat idiopathic intracranial hypertension (IIH), but there is insufficient information to establish an evidence base for its use. OBJECTIVE To determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction diet in patients with IIH and mild visual loss. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, double-masked, placebo-controlled study of acetazolamide in 165 participants with IIH and mild visual loss who received a low-sodium weight-reduction diet. Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012 and followed up for 6 months (last visit in June 2013). All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation (PMD) between −2 dB and −7 dB. The mean age was 29 years and all but 4 participants were women. INTERVENTIONS Low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide (up to 4 g/d) or matching placebo for 6 months. MAIN OUTCOMES AND MEASURES The planned primary outcome variable was the change in PMD from baseline to month 6 in the most affected eye, as measured by Humphrey Field Analyzer. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to −32 dB; larger negative values indicate greater vision loss. Secondary outcome variables included changes in papilledema grade, quality of life (Visual Function Questionnaire 25 [VFQ-25] and 36-Item Short Form Health Survey), headache disability, and weight at month 6. RESULTS The mean improvement in PMD was greater with acetazolamide (1.43 dB, from −3.53 dB at baseline to −2.10 dB at month 6; n = 86) than with placebo (0.71 dB, from −3.53 dB to −2.82 dB; n = 79); the difference was 0.71 dB (95% CI, 0 to 1.43 dB; P = .050). Mean improvements in papilledema grade (acetazolamide: −1.31, from 2.76 to 1.45; placebo: −0.61, from 2.76 to 2.15; treatment effect, −0.70; 95% CI, −0.99 to −0.41; P 
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2014.3312