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Text File | 1995-01-02 | 12KB | 332 lines

Clinical Alert: National Eye Institute Announces Ischemic Optic Neuropathy Decompression Trial (IONDT) Findings. January 3, 1995 Summary: The IONDT compared the safety and efficacy of optic nerve decompression surgery plus careful followup versus careful followup alone in patients with non-arteric ischemic optic neuropathy (NAION). Preliminary results indicate that decompression surgery was no better than careful followup, based on a detailed statistical analysis. It is concluded that optic nerve decompression surgery is not an appropriate treatment for NAION. Full Text: The following is the text of a letter, dated January 3, 1995, sent to ophthalmologists and neurologists, and signed by Dr. Carl Kupfer, Dr. Shalom Kelman, and Dr. Kay Dickersin. Dear Colleague: This letter is to inform you of findings from the Ischemic Optic Neuropathy Decompression Trial (IONDT) that warrant your attention prior to publication of the results. This randomized, controlled clinical trial is supported by the National Eye Institute (NEI), part of the National Institutes of Health, and is being conducted at 25 clinical centers nationwide (see attached list of study sites). The study is headquartered at the University of Maryland at Baltimore. The IONDT compared the safety and efficacy of optic nerve decompression surgery plus careful followup versus careful followup alone in patients with non-arteritic ischemic optic neuropathy (NAION). All patients were diagnosed with NAION by IONDT neuro-ophthalmologists. In the study, decompression surgery was standardized, and each physician's surgical ability was reviewed by the IONDT's Surgical Quality Assurance Committee. Moreover, all surgeons were required to have previously performed ten or more decompression operations to be certified to participate in the study. As of September, 1994, the study had received and analyzed outcome data from 244 patients. Of these patients, 119 had been randomized to decompression surgery and 125 to careful followup, with 95 and 91, respectively, having completed six months of followup. Preliminary results indicate that decompression surgery was no better than careful followup, based on a detailed statistical analysis. These results include: o At six months of followup, 43 percent of careful followup patients improved three or more lines of vision (using the New York Lighthouse chart). In the surgery group, 33 percent had a three-line improvement in their vision over the same followup period. Thus, surgery has no positive effect on outcome compared to careful followup. o Twelve percent of eyes in careful followup lost three or more lines of vision at six months, compared to 24 percent in the surgical group. This suggests that decompression surgery may be harmful. o The IONDT's finding that 43 percent of careful followup patients had spontaneous improvement of three or more lines in their vision (See Bullet 1) is much higher than previously reported. Most of the earlier studies had indicated a spontaneous improvement rate of ten percent or less. o No beneficial surgical effect on visual acuity was seen in patients with progressive visual loss. In late October 1994, the IONDT's Data and Safety Monitoring Committee reviewed these preliminary findings and recommended that recruitment to the IONDT cease with enrolled patients continuing to be followed. Thereafter, the NEI halted patient recruitment, and study investigators reviewed the data. A scientific paper was submitted to the Journal of the American Medical Association for expedited review in mid-November, was accepted, and will be published in an upcoming issue of the Journal. Based on the above results, we conclude that optic nerve decompression surgery is not an appropriate treatment for NAION. We can offer no recommendation regarding the safety and efficacy of this surgery for other conditions. Sincerely, ------------------------------------------------------- Carl Kupfer, M.D. Director National Eye Institute ------------------------------------------------------- Shalom Kelman, M.D. IONDT Chairman University of Maryland at Baltimore School of Medicine ------------------------------------------------------- Kay Dickersin, Ph.D. Director, IONDT Coordinating Center University of Maryland at Baltimore School of Medicine ------------------------------------------------------- ------------------------------------------------------- ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL ------------------------------------------------------- PARTICIPANTS LIST ------------------------------------------------------- California Steven Feldon, M.D. Doheny Eye Institute University of Southern California 1450 San Pablo Street Los Angeles, California 90033- 4683 Telephone: (213) 342-6488 ------------------------------------------------------- Anthony Arnold, M.D. Jules Stein Eye Institute 100 Stein Plaza, UCLA Los Angeles, California 90024-7005 Telephone: (310) 825-4344 ------------------------------------------------------- Jonathan Horton, M.D. Department of Ophthalmology University of California, San Francisco Eight Kirkham Street San Francisco, California 94143-0644 Telephone: (415) 476-7176 ------------------------------------------------------- Florida John R. Guy, M.D. Department of Ophthalmology University of Florida Box 100-284, JHMHC Gainesville, Florida 32610-0284 Telephone: (904) 392-3451 ------------------------------------------------------- Georgia Nancy J. Newman, M.D. Emory Eye Center Emory University 1327 Clifton Road, N.E. Atlanta, Georgia 30322 Telephone: (404) 248-5358 ------------------------------------------------------- Illinois James A. Goodwin, M.D. Department of Ophthalmology University of Illinois 1855 West Taylor Street Chicago, Illinois 60612 Telephone: (312) 996-9120 ------------------------------------------------------- Kentucky Robert S. Baker, M.D. Department of Ophthalmology University of Kentucky Room E304 Kentucky Clinic 801 Rose Street Lexington, Kentucky 40536-0284 Telephone: (606) 323-5875 ------------------------------------------------------- Maryland Shalom E. Kelman, M.D. Professional Building University of Maryland 419 West Redwood Street Suite 420 Baltimore, Maryland 21201 Telephone: (410) 328-3858 ------------------------------------------------------- Michigan Wayne Cornblath, M.D. W. K. Kellogg Eye Center University of Michigan 1000 Wall Street Ann Arbor, Michigan 48105 Telephone: (313) 936-9503 ------------------------------------------------------- Barry Skarf, M.D. Henry Ford Hospital Department of Ophthalmology K-10 2799 West Grand Boulevard Detroit, Michigan 48202 Telephone: (313) 876-3243 ------------------------------------------------------- David I. Kaufman, D.O. Department of Ophthalmology Michigan State University Unit for Neuro-visual Disorders A217 Clinical Center 138 Service Road East Lansing, Michigan 48824 Telephone: (517) 432-4923 ------------------------------------------------------- Edward Cohn, M.D. William Beaumont Eye Institute William Beaumont Hospital 3535 West Thirteen Mile Suite 506 Royal Oak, Michigan 48073 Telephone: (810) 551-8282 ------------------------------------------------------- Minnesota Brian R. Younge, M.D. Mayo Clinic, E-7A Mayo Building 200 First Street, S.W. Rochester, Minnesota 55905 Telephone: (507) 284-5833 ------------------------------------------------------- Missouri Lenworth Johnson, M.D. Mason Eye Institute University of Missouri - Columbia One Hospital Drive Columbia, Missouri 65212 Telephone: (314) 882-5935 ------------------------------------------------------- Sophia M. Chung, M.D. Anheuser-Busch Eye Institute 1755 South Grand Boulevard St. Louis, Missouri 63104 Telephone: (314) 865-8323 ------------------------------------------------------- New York Deborah Friedman, M.D. SUNY Health Science Center 750 East Adams Street Syracuse, New York 13210 Telephone: (315) 464-5253 ------------------------------------------------------- North Carolina Mark Malton, M.D. Carolinas Medical Center 2015 Randolph Road, Suite 108 Charlotte, North Carolina 28207 Telephone: (704) 334-2020 ------------------------------------------------------- Ohio Gregory Kosmorsky, D.O. The Cleveland Clinic Foundation Desk A 31/Ophthalmology 9500 Euclid Avenue Cleveland, Ohio 44195 Telephone: (216) 444-2855 ------------------------------------------------------- Pennsylvania John Kennerdell, M.D. Allegheny General Hospital 420 East North Avenue, Suite 116 Pittsburgh, Pennsylvania 15212 Telephone: (412) 359-6300 ------------------------------------------------------- South Carolina Mitchell J. Wolin, M.D. University of South Carolina Department of Ophthalmology #4 Richland Medical Park, Suite 100 Columbia, South Carolina 29203 Telephone: (803) 224-6375 ------------------------------------------------------- Texas Rosa A. Tang, M.D. University of Texas 2476 Bolsover, #359 Houston, Texas 77005 Telephone: (713) 668-6828, ------------------------------------------------------- Utah Kathleen A. Digre, M.D. University of Utah Department of Ophthalmology 50 North Medical Drive Salt Lake City, Utah 84132 Telephone: (801) 581-7614 ------------------------------------------------------- Virginia Steven A. Newman, M.D. University of Virginia Department of Ophthalmology Box 475 Charlottesville, Virginia 22908 Telephone: (804) 924-5978 ------------------------------------------------------- Warren L. Felton III, M.D. Department of Neurology Division of Neuro-ophthalmology Medical College of Virginia Box 980599 Richmond, Virginia 23298-0599 Telephone: (804) 828-4806 ------------------------------------------------------- West Virginia John Linberg, M.D. West Virginia University Department of Ophthalmology P.O. Box 9193 Morgantown, West Virginia 26506 Telephone: (304) 293-3757 ------------------------------------------------------- ------------------------------------------------------- RESOURCE CENTERS ------------------------------------------------------- Chairman's Office Shalom E. Kelman, M.D. Professional Building University of Maryland 419 West Redwood Street Suite 460 Baltimore, Maryland 21201 Telephone: (410) 328-3858 ------------------------------------------------------- Coordinating Center Kay Dickersin, Ph.D. Department of Epidemiology & Preventive Medicine University of Maryland 228 Howard Hall 660 West Redwood Street Baltimore, Maryland 21201 Telephone: (410) 328-8159 ------------------------------------------------------- The full text of this alert has been mailed to all libraries that are members of the National Network of Libraries of Medicine.