TY - JOUR
T1 - Risk factors for poor visual outcome in patients with idiopathic intracranial hypertension
AU - Wall, Michael
AU - Falardeau, Julie
AU - Fletcher, William A.
AU - Granadier, Robert J.
AU - Lam, Byron L.
AU - Longmuir, Reid A.
AU - Patel, Anil D.
AU - Bruce, Beau B.
AU - He, Hua
AU - McDermott, Michael P.
N1 - Funding Information:
Steering Committee: Michael Wall, MD (principal investigator) (University of Iowa), James Corbett, MD (University of Mississippi Medical Center), Steven Feldon, MD, MBA (David & Ilene Flaum Eye Institute, University of Rochester School of Medicine & Dentistry), Deborah Friedman, MD (UT Southwestern Medical Center), John Keltner, MD (UC Davis Medical Center), Karl Kieburtz, MD, MPH (David & Ilene Flaum Eye Institute, University of Rochester School of Medicine & Dentistry), Mark Kupersmith, MD (network chair) (Roosevelt Hospital), Michael P. McDermott, PhD (David & Ilene Flaum Eye Institute, University of Rochester School of Medicine & Dentistry), Eleanor B. Schron, PhD, RN (project officer, National Eye Institute), David Katz, MD (Bethesda Neurology LLC), Tippi Hales (Raleigh Neurology Associates PA); Cindy Casaceli, MBA (David & Ilene Flaum Eye Institute, University of Rochester School of Medicine & Dentistry). This trial was funded by the National Eye Institute. This work was supported by NORDIC 1U10EY017281-01A1, DCBC 1U10EY017387-01A1, ARRA for NORDIC 3U10EY017281-01A1S1 DCBC 1U10EY017387-01A1S1, supplements for NORDIC 3U10EY017281-01A1S2 and K23 EY019341 (B.B.B.). Role of the sponsor: A representative of the sponsor (NEI), Eleanor Schron, PhD, served on the steering committee. Also, the NEI appointed a data and safety monitoring board (DSMB) to monitor participant safety and oversee study conduct and progress. DSMB members were independent academic leaders who received funding from NEI for their DSMB service. The NEI had no other role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript and decision to submit the manuscript for publication. The authors and steering committee members contributed to management, analysis, and interpretation of the data and review of the manuscript. The sites contributed to data collection and compensation was received for patient care. Others contributed to the study design, methods, conduct, and procedures; their efforts were supported by NIH U10 EY017281. Michael Wall, Hua He, and Michael McDermott had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The corresponding author (Michael Wall) has obtained written permission from all persons named in the acknowledgment section.
Publisher Copyright:
© 2015 American Academy of Neurology.
PY - 2015/9/1
Y1 - 2015/9/1
N2 - Objectives: Determine potential risk factors for progressive visual field loss in the Idiopathic Intracranial Hypertension Treatment Trial, a randomized placebo-controlled trial of acetazolamide in patients with idiopathic intracranial hypertension and mild visual loss concurrently receiving a low sodium, weight reduction diet. Methods: Logistic regression and classification tree analyses were used to evaluate potential risk factors for protocol-defined treatment failure (>2 dB perimetric mean deviation [PMD] change in patients with baseline PMD-2 to-3.5 dB or >3 dB PMD change with baseline PMD-3.5 to-7 dB). Results: Seven participants (6 on diet plus placebo) met criteria for treatment failure. The odds ratio for patients with grades III to V papilledema vs those with grades I and II was 8.66 (95% confidence interval [CI] 1.65-∞, p 0.025). A 1-unit decrease in the number of letters correct on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at baseline was associated with an increase in the odds of treatment failure by a factor of 1.16 (95% CI 1.04-1.30, p 0.005). Compared with female participants, the odds ratio for male participants was 26.21 (95% CI 1.61-433.00, p 0.02). The odds of treatment failure were 10.59 times higher (95% CI 1.63-116.83, p 0.010) for patients with >30 transient visual obscurations per month vs those with ≤30 per month. Conclusions: Male patients, those with high-grade papilledema, and those with decreased visual acuity at baseline were more likely to experience treatment failure. All but one of these patients were treated with diet alone. These patients should be monitored closely and be considered for aggressive treatment of their idiopathic intracranial hypertension.
AB - Objectives: Determine potential risk factors for progressive visual field loss in the Idiopathic Intracranial Hypertension Treatment Trial, a randomized placebo-controlled trial of acetazolamide in patients with idiopathic intracranial hypertension and mild visual loss concurrently receiving a low sodium, weight reduction diet. Methods: Logistic regression and classification tree analyses were used to evaluate potential risk factors for protocol-defined treatment failure (>2 dB perimetric mean deviation [PMD] change in patients with baseline PMD-2 to-3.5 dB or >3 dB PMD change with baseline PMD-3.5 to-7 dB). Results: Seven participants (6 on diet plus placebo) met criteria for treatment failure. The odds ratio for patients with grades III to V papilledema vs those with grades I and II was 8.66 (95% confidence interval [CI] 1.65-∞, p 0.025). A 1-unit decrease in the number of letters correct on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at baseline was associated with an increase in the odds of treatment failure by a factor of 1.16 (95% CI 1.04-1.30, p 0.005). Compared with female participants, the odds ratio for male participants was 26.21 (95% CI 1.61-433.00, p 0.02). The odds of treatment failure were 10.59 times higher (95% CI 1.63-116.83, p 0.010) for patients with >30 transient visual obscurations per month vs those with ≤30 per month. Conclusions: Male patients, those with high-grade papilledema, and those with decreased visual acuity at baseline were more likely to experience treatment failure. All but one of these patients were treated with diet alone. These patients should be monitored closely and be considered for aggressive treatment of their idiopathic intracranial hypertension.
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U2 - 10.1212/WNL.0000000000001896
DO - 10.1212/WNL.0000000000001896
M3 - Article
C2 - 26245929
AN - SCOPUS:84959042794
VL - 85
SP - 799
EP - 805
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 9
ER -