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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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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.
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.
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.
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.
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