Clinical Alert: National Eye Institute Announces Ischemic OpticNeuropathy Decompression Trial (IONDT) Findings

National Eye Institute (NEI)
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:

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.
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.
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.
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; P.O. 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.

Last updated: 15 March 1996
First published: 03 January 1995
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