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Show Letters to the Editor REFERENCES 1. Kupersmith MJ, Miller NR, Levin LA. New treatments in NeuroOphthalmology: the role for evidence. J Neurophthalmol. 2017;37:1-2. 2. Hayreh SS, Zimmerman MB. Non-arteritic anterior ischemic optic neuropathy: role of systemic corticosteroid therapy. Graefes Arch Clin Exp Ophthalmol. 2008;246:1029-1046. 3. Hayreh SS. Ischemic optic neuropathies-where are we now? Graefes Arch Clin Exp Ophthalmol. 2013;251:1873-1884. 4. Rebolleda G, Pérez-López M, Casas-Llera P, Contreras I, MuñozNegrete FJ. Visual and anatomical outcomes of non-arteritic Corticosteroid Therapy in Nonarteritic Anterior Ischemic Optic Neuropathy: Response W e thank Dr. Hayreh for the opportunity to continue the discussion on this most important topic- namely, the need for Level I evidence in medicine to assess potential therapies. We recognize and appreciate Dr. Hayreh's contributions to the understanding of nonarteritic anterior ischemic optic neuropathy (NAION), and we are sorry that he seems to have misinterpreted our commentary as a personal attack. Our editorial is an unbiased evaluation of the issue of steroid treatment of NAION and, more importantly, a plea for well-designed, prospective clinical trials that collect and analyze meaningful data and come to an evidence-based conclusion regarding the efficacy of a potential therapy. These trials must include masking and randomization, for without them, the conclusions could be flawed. Even when unintended, bias from study subjects and investigators are known contaminants. Uncontrolled cases series, no matter how many patients are included, are still simply large series, and physicians should be cautious in interpreting the results of such studies, as the studies do not follow the accepted principles for conduct- Role of Nocturnal Arterial Hypotension in Nonarteritic Anterior Ischemic Optic Neuropathy I was interested to read the discussion of the role of nocturnal arterial hypotension in nonarteritic anterior ischemic optic neuropathy (NAION) (1). Since my studies were the first to raise this issue (2-4), I believe that a number of comments are in order. It was stated that my 24-hour ambulatory blood pressure monitoring (ABPM) studies (2,3) in patients with NAION had no control group and, therefore, the "data had significant limitations." I have discussed at length why it is impossible to have a valid control group in such a study (2), given the fact 350 anterior ischemic optic neuropathy with high-dose systemic corticosteroids. Graefes Arch Clin Exp Ophthalmol. 2013;251:255-260. 5. Pakravan M, Sanjari N, Esfandiari H, Pakravan P, Yaseri M. The effect of high-dose steroids, and normobaric oxygen therapy, on recent onset non-arteritic anterior ischemic optic neuropathy: a randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2016;254:2043-2048. 6. Hayreh SS. Treatment of non-arteritic anterior ischemia optic neuropathy with high-dose systemic corticosteroid therapy. Graefes Arch Clin Exp Ophthalmol. 2013;251:1029-1030. ing clinical trials. Uncontrolled data are useful for generating hypotheses and exploring new concepts, but they should be viewed only as pilot or preliminary information on which to base controlled clinical trials. We recommend that, given his expertise in this area, Dr. Hayreh attempt once again to perform a prospective trial of steroid therapy for NAION using the methodology that all trials of investigational agents require to properly test a hypothesis. Mark J. Kupersmith, MD Icahn School of Medicine at Mount Sinai and New York Eye and Ear Infirmary, New York, New York Neil R. Miller, MD Johns Hopkins School of Medicine and Wilmer Eye Institute, Baltimore, Maryland Leonard A. Levin, MD, PhD McGill University Faculty of Medicine, Montreal, Canada University of Wisconsin, Madison, Wisconsin The authors report no conflicts of interest. that NAION is a multifactorial disease with many systemic and optic nerve head risk factors. Hence, a true control population would have to be matched for systemic and optic nerve head factors in addition to age and sex. My studies, in fact, had an important built-in reliable control, because patients with nocturnal hypotension, compared with those without it, had a significant association with progression of visual field deterioration in NAION. The ABPM study in 24 patients with NAION by Landau et al (5) has been cited as contradictory to my findings regarding nocturnal arterial hypotension in NAION. I have discussed at length the flaws in that study which invalidate its conclusions (6). Anthony Arnold, MD, raised a number of concerns regarding the data from my studies. Following are my responses. Letters to the Editor: J Neuro-Ophthalmol 2017; 37: 347-353 Copyright © North American Neuro-Ophthalmology Society. Unauthorized reproduction of this article is prohibited. |
