Quality of life at 6 months in the Idiopathic Intracranial Hypertension Treatment Trial.
OBJECTIVE
To examine the changes in vision-specific and overall health-related quality of life (QOL) at 6 months in participants with idiopathic intracranial hypertension (IIH) and mild visual loss enrolled in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to determine the signs and symptoms of IIH that mediate the effect of acetazolamide on QOL.


METHODS
We assessed QOL using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), the 10-Item NEI-VFQ-25 Neuro-Ophthalmic Supplement, and the 36-Item Short Form Health Survey (SF-36). We examined associations among changes in QOL measures over 6 months, treatment status, and changes in signs and symptoms using linear and structural equation models.


RESULTS
Among the 165 participants with IIH (86 randomized to acetazolamide, 79 to placebo), beneficial effects of acetazolamide were seen on all QOL scales evaluated, as well as on the Near Activities (5.60 points, p = 0.03), Social Functioning (3.85 points, p = 0.04), and Mental Health (9.82, p = 0.04) subscales of the NEI-VFQ-25. Positive acetazolamide-related effects on QOL appeared to be primarily mediated by improvements in visual field, neck pain, pulsatile tinnitus, and dizziness/vertigo that outweighed the side effects of acetazolamide.


CONCLUSIONS
The marked reductions in baseline QOL seen among patients with mild visual loss from IIH are improved by treatment with acetazolamide. When combined with acetazolamide-associated improvements in visual field and other aspects of IIH, our findings with respect to QOL provide further support from the IIHTT in favor of acetazolamide to augment a dietary intervention in the treatment of IIH with mild visual loss (clinicaltrials.gov: NCT01003639).
From the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City. bbbruce@emory.edu.
Beau B
BB
Bruce
From the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
Kathleen B
KB
Digre
From the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
Michael P
MP
McDermott
From the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
Eleanor B
EB
Schron
From the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
Michael
M
Wall
D000086:Acetazolamide / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D002257:Carbonic Anhydrase Inhibitors / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011559:Pseudotumor Cerebri / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology*; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000187:drug effects*; D055815:Young Adult
D002257:Carbonic Anhydrase Inhibitors; D000086:Acetazolamide
J Neurol Neurosurg Psychiatry. 1982 Jan;45(1):13-8
7062066
BMC Health Serv Res. 2014 Jul 22;14:317
25052136
Am J Ophthalmol. 2000 Jun;129(6):831
10927006
Arch Ophthalmol. 2001 Jul;119(7):1050-8
11448327
Qual Life Res. 2003 Dec;12(8):963-74
14651415
J Clin Neuroophthalmol. 1985 Mar;5(1):55-6
3156890
Am J Ophthalmol. 2006 Dec;142(6):1026-35
17046704
Arch Ophthalmol. 1977 Aug;95(8):1378-82
889513
Am J Ophthalmol. 2007 Apr;143(4):635-41
17386271
Arch Ophthalmol. 2010 Jun;128(6):705-11
20547947
Neurology. 2015 Jun 16;84(24):2449-56
25995055
JAMA Neurol. 2014 Jun;71(6):693-701
24756302
JAMA. 2014 Apr 23-30;311(16):1641-51
24756514
J Neuroophthalmol. 2016 Mar;36(1):13-9
26587993