Journal article
Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial
JAMA : the journal of the American Medical Association, Vol.311(16), pp.1641-1651
04/23/2014
DOI: 10.1001/jama.2014.3312
PMCID: PMC4362615
PMID: 24756514
Abstract
Acetazolamide is commonly used to treat idiopathic intracranial hypertension (IIH), but there is insufficient information to establish an evidence base for its use. 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. 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. Low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide (up to 4 g/d) or matching placebo for 6 months. 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. 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 < .001) and vision-related quality of life as measured by the National Eye Institute VFQ-25 (acetazolamide: 8.33, from 82.97 to 91.30; placebo: 1.98, from 82.97 to 84.95; treatment effect, 6.35; 95% CI, 2.22 to 10.47; P = .003) and its 10-item neuro-ophthalmic supplement (acetazolamide: 9.82, from 75.45 to 85.27; placebo: 1.59, from 75.45 to 77.04; treatment effect, 8.23; 95% CI, 3.89 to 12.56; P < .001) were also observed with acetazolamide. Participants assigned to acetazolamide also experienced a reduction in weight (acetazolamide: -7.50 kg, from 107.72 kg to 100.22 kg; placebo: -3.45 kg, from 107.72 kg to 104.27 kg; treatment effect, -4.05 kg, 95% CI, -6.27 to -1.83 kg; P < .001). In patients with IIH and mild visual loss, the use of acetazolamide with a low-sodium weight-reduction diet compared with diet alone resulted in modest improvement in visual field function. The clinical importance of this improvement remains to be determined. clinicaltrials.gov Identifier: NCT01003639.
Details
- Title: Subtitle
- Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial
- Creators
- Michael Wall - University of Iowa, Iowa CityMichael P McDermott - University of RochesterKarl D Kieburtz - University of RochesterJames J Corbett - University of Mississippi Medical Center, JacksonSteven E Feldon - University of Rochester Eye Institute, Rochester, New YorkDeborah I Friedman - University of Texas Southwestern Medical Center, DallasDavid M KatzJohn L Keltner - University of California, Davis Medical CenterEleanor B Schron - National Eye Institute, Bethesda, MarylandMark J Kupersmith - Roosevelt Hospital, New York, New YorkNORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee
- Resource Type
- Journal article
- Publication Details
- JAMA : the journal of the American Medical Association, Vol.311(16), pp.1641-1651
- DOI
- 10.1001/jama.2014.3312
- PMID
- 24756514
- PMCID
- PMC4362615
- NLM abbreviation
- JAMA
- ISSN
- 0098-7484
- eISSN
- 1538-3598
- Publisher
- United States
- Grant note
- 3U10EY017281-01A1S2 / NEI NIH HHS 1U10EY017281-01A1 / NEI NIH HHS 3U10EY017281-01A1S1 / NEI NIH HHS 1U10EY017387-01A1S1 / NEI NIH HHS U10 EY017387 / NEI NIH HHS U10 EY017281 / NEI NIH HHS 1U10EY017387-01A1 / NEI NIH HHS
- Language
- English
- Date published
- 04/23/2014
- Academic Unit
- Neurology; Ophthalmology and Visual Sciences
- Record Identifier
- 9983980074602771
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