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Optic Nerve Decompression Surgery for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Is Not Effective and May Be Harmful
The Ischemic Optic Neuropathy Decompression Trial Research Group;
Kay Dickersin, PhD;
Donald Everett, MA;
Steven Feldon, MD;
Frank Hooper, ScD;
David Kaufman, DO;
Shalom Kelman, MD;
Patricia Langenberg, PhD;
Nancy J. Newman, MD;
P. David Wilson, PhD;
Z. Suzanne Zam;
John Kennerdell, MD;
Anna Tyutyunikov, MD;
Russell Edwards, MD;
Todd Goodglick, MD;
Deborah Lang;
Kimberly Peele, MD;
Sophia Chung, MD;
Diana Mekelburg, COT;
John Holds, MD;
John Selhorst, MD;
Mark Malton, MD;
Sonia Armstrong, COT;
Yvonne McCracken, MPH;
Eugene Benjamin, MD;
Carol Dellinger;
Traci Hunter Medlin, COT;
Barbara Kinsler;
Mike McOwen, CLP;
Donna Russell, COT;
Timothy Saunders, MD;
Gregory Kosmorsky, DO;
Tina Kiss;
Cate Reinhard;
Laura De Venne;
Janet Edgerton;
Tami Fecko;
Susannah Hanson;
Brian Kraus;
Deborah Ross;
Nancy Tomsak;
Pamela Vargo;
Rufus Willis;
Steven Feldon, MD;
Kerry Zimmerman, MS;
Kristin Anderson, COMT;
Richard Cortez;
Karen DeBlanc, COA;
Judy Hulse, COT;
Ronald B. Morales;
Tracy Nichols, CRA;
Lillian Reyes, COT;
Nadine Rodarte-Ochoa, COT;
Daniel Romo;
Alfredo Sadun, MD;
Mary Steber, COMT;
Frances Walonker, COMT;
Nancy J. Newman, MD;
Donna Loupe, BA;
Diana Coffman, MMSc;
Harvey Cole III, MD;
Ted Wojno, MD;
Barry Skarf, MD;
Colleen Wojtala;
Mark Croswell;
Wendy Gilroy;
Christian Mageli;
Dena McDonald;
George Ponka;
Rosa Tang, MD;
Melissa Hamlin;
Jewel Curtis;
Jay Forman;
Kenneth Hyde, MD;
Kirk Mack;
Portia Tello;
Anthony Arnold, MD;
Berniee Cibener, BA;
Melody Acero;
Bobbi Ballenberg, COMT;
Anne Bolton;
Robert Goldberg, MD;
Lynn Gordon, MD;
Michael Heneghan;
Howard Krauss, MD;
Jackie Sanguinei;
Robert Stalling;
Jenja Yadegaran, BS;
Wayne Cornblath, MD;
Barbara Michael;
Donna Campbell, COT;
Cheryl Caudill, COT;
Christine Nelson, MD;
Jonathan Trobe, MD;
Lenworth N. Johnson, MD;
Gaye Baker;
Coy Cobb, CRA, COT;
Philip Custer, MD;
Sharon Turner, COA;
Roy Wilson, MS, COMT;
Brian Younge, MD;
Jacqueline Leavitt, MD;
Rebecca Nielsen, LPN;
Jody Allen;
Barbara Eickhoff, COT;
James Garrity, MD;
Jacqueline Ladsten;
Kathleen LeBarron, COA;
Thomas P. Link, BA;
Jay Rostvold;
Karen Weber;
Warren Felton III, MD;
Tracy Boney, AS;
Danielle Gabriel, BS;
Daniel David, MS;
Lahn Fendelander, MS;
Daniel Geller, MD;
Timothy Jordan, MD;
Christian Kim, MD;
Craig Munger, MD;
Jo Anne Romandy, COA;
George Sanborn, MD;
Bradley Schwartz, MD;
Carl Sheusi, BA;
Constance Smith, MD;
Kathy Talley, AS;
Sandya Thimmappa, BS;
David Kaufman, DO;
Eric Eggenberger, DO;
Suzanne Bickert, RN;
Robert Granadier, MD;
Sandra Holliday;
Thomas Moore, MD;
Jaya Varadarajan, MD;
Deborah Friedman, MD;
Patricia Jones, LPN, COT;
Haris Amin, MD;
Thomas Bersani, MD;
Cynthia Briglin, MD;
James Fooks;
Michael Graham, MD;
Milton James, MD;
Gary Michalec;
Hoang Nguyen;
Jonathan Horton, MD;
Maeve Chang, BA;
Lou Anne Aber, COA;
Erik Lindstrom, COMT;
Stuart Seiff, MD;
John Guy, MD;
Z. Suzanne Zam, BS;
Amye Francis, CO;
Latif Hamed, MD;
Alan Lessner, MD;
Donna McDavid, COMT;
Diana Shamis, MHSE;
James Goodwin, MD;
Martin E. Lindeman, COMT;
Allen Putterman, MD;
Phyllis Bobak, PhD;
Robert Baker, MD;
Judy Beck;
David Cowen, MD;
Avrom Epstein, MD;
Michael Hanson;
Toni Scoggins, COA;
Shalom Kelman, MD;
Ann M. Rodavitch, MA;
Brenda Gore;
Andrea Blake, MA;
Michele Heroux, CRA;
Rani Kalsi;
Charlene Krauch, COMT;
Mary Ann Millar, COMT;
Mitchell Wolin, MD;
Rita Jean Brady, COA;
Regina Hansen, COA;
Michael Briggs;
Karkarla V. Chalam, MD;
Barbara Danner;
Beverly Simons, COT;
Anne Stewart, CO;
Kathleen Digre, MD;
Lizbeth Malmquist-Webb;
Terrell Blackburn;
Susan Baggaley;
Richard Anderson, MD;
Charles Juarez;
Bonnie Kaye;
Paul Langer, MD;
Aditya Mishra, MD;
Paula Morris;
Sandra Osborn;
Bhupendra Patel, MD;
Tessie Priskos;
Sandra Staker;
Judith Warner, MD;
Steven Newman, MD;
Christine Evans, COT;
Allison Aylor, COT;
Carolyn Childress, COA;
Helen Dickerson, RN;
Jane Fleming, BA;
Nomine Harris, BA;
L. Sharon Hoyle, COMT;
Ellen Murphy, COT;
James Scott, RBP;
Karen Summerville, COMT;
Mariann Terrell, CO;
Lillian Tyler, COA;
John Linberg, MD;
Lenore Breen, MD;
Michelle Michael, COT;
Charlene Campbell, COT;
Brian Ellis, MD;
Nancy Groves, COA;
Robert Hobson;
Gordon McGregor;
Laura Shepherd, COA;
Edward Cohn, MD;
Patricia Manatrey;
Sara Casey;
Robert Granadier, MD;
John Johnson;
Coletti Kronner;
Virginia Regan;
Patricia Streasick;
Shalom Kelman, MD;
Michael Elman, MD;
Andrea Blake, MA;
Aim M. Rodavitch, MA;
Kay Dickersin, PhD;
Frank Hooper, ScD;
Roberta Scherer, PhD;
Barbara Crawley, MS;
Michael Elman, MD;
Cheryl Hiner;
Lucy Howard;
Patricia Langenberg, PhD;
Olga Lurye;
Robert McCarter, ScD;
Sara Riedel;
Michelle Sotos;
Laureen Spioch;
Joann Starr;
Judy Urban;
Mark Waring;
P. David Wilson, PhD;
Donald Everett, MA;
Barbara Crawley, MS;
Kay Dickersin, PhD;
Frank Hooper, ScD;
Patricia Langenberg, PhD;
Robert McCarter, ScD;
Roberta Scherer, PhD;
P. David Wilson, PhD;
Shalom Kelman, MD;
Kay Dickersin, PhD;
Michael Elman, MD;
Donald Everett, MA;
Frank Hooper, ScD;
Frank Hooper, ScD;
Shalom Kelman, MD;
Roberta Scherer, PhD;
Danielle Gabriel;
Shalom Kelman, MD;
Kay Dickersin, PhD;
Michael Elman, MD;
Donald Everett, MA;
Steven Feldon, MD;
Frank Hooper, ScD;
David Kaufman, DO;
Nancy J. Newman, MD;
Z. Suzanne Zam, BS;
Steven Feldon, MD;
Robert Baker, MD;
Frank Hooper, ScD;
Shalom Kelman, MD;
Gregory Kosmorsky, DO;
Stuart R. Seiff, MD
JAMA. 1995;273(8):625-632.
Abstract
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Objective.
—To assess the safety and efficacy of optic nerve decompression surgery compared with careful follow-up alone in patients with nonarteritic anterior ischemic optic neuropathy (NAION).
Design.
—The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single-masked, multicenter trial.
Setting.
—Twenty-five US clinical centers.
Participants.
—The IONDT ceased recruitment on October 20, 1994, on the recommendation of its Data and Safety Monitoring Committee. The preliminary results presented herein are based on data as of September 8,1994, from 244 patients with NAION and visual acuity of 20/64 or worse. One hundred twenty-five patients had been randomized to careful follow-up, and 119 had been randomized to surgery, with 91 and 95, respectively, having completed 6 months of follow-up.
Intervention.
—Patients in the surgery group received optic nerve decompression surgery and follow-up ophthalmologic examinations; those in the careful follow-up group received ophthalmologic examinations at the same times as the surgery group.
Main Outcome Measures.
—Gain or loss of three or more lines of visual acuity on the New York Lighthouse chart at 6 months after randomization, as measured by a technician masked to treatment assignment.
Results.
—Patients assigned to surgery did no better when compared with patients assigned to careful follow-up regarding improved visual acuity of three or more lines at 6 months: 32.6% of the surgery group improved compared with 42.7% of the careful follow-up group. The odds ratio (OR) for three or more lines better, adjusted for baseline visual acuity and diabetes, was 0.74 (95% confidence interval [CI], 0.39 to 1.38). Patients receiving surgery had a significantly greater risk of losing three or more lines of vision at 6 months: 23.9% in the surgery group worsened compared with 12.4% in the careful follow-up group. The 6-month adjusted OR for three or more lines worse was 1.96 (95% CI, 0.87 to 4.41). No difference in treatment effect was observed between patients with progressive NAION and all others.
Conclusion.
—Results from the IONDT indicate that optic nerve decompression surgery for NAION is not effective, may be harmful, and should be abandoned. The spontaneous improvement rate is better than previously reported.
(JAMA. 1995;273:625-632)
Author Affiliations
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From the Ischemic Optic Neuropathy Decompression Trial Research Group.
Writing Committee; Clinical Centers: Allegheny General Hospital, Pittsburgh, Pa; Anheuser-Busch Eye Institute, St Louis (Mo) University Health Sciences Center; Carolinas Medical Center, Charlotte, NC; Cleveland (Ohio) Clinic Foundation; Doheny Eye Institute, Los Angeles, Calif; Emory University, Atlanta, Ga; Henry Ford Hospital, Detroit, Mich; University of Texas, Houston; Jules Stein Eye Institute, Los Angeles, Calif; W. K. Kellogg Eye Center, University of Michigan, Ann Arbor; Mason Institute of Ophthalmology, Columbia, Mo; Mayo Clinic, Rochester, Minn; Medical College of Virginia, Richmond; Michigan State University, East Lansing; State University of New York, Syracuse; University of California, San Francisco; University of Florida, Gainesville; University of Illinois, Chicago; University of Kentucky, Lexington; University of Maryland, Baltimore; University of South Carolina, Columbia; University of Utah, Salt Lake City; University of Virginia, Charlottesville; West Virginia University, Morgantoum; William Beaumont Hospital, Royal Oak, Mich; Resource Centers: Chairman's Office, University of Maryland School of Medicine, Baltimore; Coordinating Center, University of Maryland School of Medicine, Baltimore; National Eye Institute, Bethesda, Md; Committees: Data Analysis Committee; Executive Committee; Quality Assurance Committee; Steering Committee; Surgical Quality Assurance Committee
Footnotes
The major participants in the Ischemic Optic Neuropathy Decompression Trial are listed at the end of this article.
Reprint requests to the Department of Ophthalmology, University of Maryland School of Medicine, 419 W Redwood St, Baltimore, MD 21201 (Shalom Kelman, MD).
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