April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
The Idiopathic Intracranial Hypertension Treatment Trial: a Multicenter, Double-Blind, Randomized Clinical Trial Comparing Acetazolamide and Placebo on Visual Outcome
Author Affiliations & Notes
  • Michael Wall
    Neurology & Ophthalmology, Univ of Iowa, Carver Coll of Med, Iowa City, IA
  • Footnotes
    Commercial Relationships Michael Wall, None
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Investigative Ophthalmology & Visual Science April 2014, Vol.55, 3545. doi:
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      Michael Wall, ; The Idiopathic Intracranial Hypertension Treatment Trial: a Multicenter, Double-Blind, Randomized Clinical Trial Comparing Acetazolamide and Placebo on Visual Outcome. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3545.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: There are no randomized controlled trials on which to base a rational treatment strategy for idiopathic intracranial hypertension (IIH).Our goal was to determine whether acetazolamide is beneficial in improving vision when added to a low sodium, weight reduction diet in IIH patients with mild visual field loss.

Methods: Our study design was a multicenter randomized, double-masked, placebo-controlled study of acetazolamide in IIH subjects with mild visual loss who were receiving a low sodium, weight reduction diet. We enrolled 165 subjects at 38 academic and private practice sites in North America. and followed them for 6 months. All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation (PMD) between -2 dB and -7 dB. The preplanned primary outcome variable was the change in PMD from baseline to Month 6 in the most affected eye, as measured by Humphrey Field Analyzer 24-2. Secondary outcome variables included changes in papilledema grade, quality of life (VFQ-25 and SF-36), headache disability, and weight at Month 6.

Results: The mean age was 29 years and all but four participants were women. The mean improvement in PMD was greater with acetazolamide (1.43 dB, n = 86) than with placebo (0.71 dB, n = 79); the difference was 0.71 dB (95% CI, 0.00 to 1.43 dB; p = 0.05). Acetazolamide also led to improvements in papilledema grade (-0.70; 95% CI, -0.99 to -0.41; p < 0.001) and quality of life outcomes (VFQ-25 total score: 6.35, 95% CI, 2.22 to 10.47, p = 0.003; VFQ-25 neuro-ophthalmic supplement: 8.23, 95% CI, 3.89 to 12.56, p < 0.001) and reduction in weight (-4.05 kg, 95% CI, -6.27 to -1.83 kg; p < 0.001). The mean (± standard deviation) dosage of study medication attained was 2.5 ± 1.5 g in the acetazolamide group and 3.5 ± 1.1 g in the placebo group. Thirty-two subjects (19%) prematurely withdrew from the trial, 16 in each treatment group.

Conclusions: We found statistically significant improvements in visual field function, papilledema grade, and quality of life with acetazolamide and recommend using the maximally tolerated dosage of acetazolamide in addition to a low sodium, weight reduction diet in IIH patients with mild visual loss.

Keywords: 613 neuro-ophthalmology: optic nerve • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials  
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