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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.