Abstract
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). —The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single-masked, multicenter trial. —Twenty-five US clinical centers. —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. —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. —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. —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. —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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 625-632 |
| Number of pages | 8 |
| Journal | JAMA: The Journal of the American Medical Association |
| Volume | 273 |
| Issue number | 8 |
| DOIs | |
| State | Published - Feb 1995 |
| Externally published | Yes |
ASJC Scopus subject areas
- Medicine(all)
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Optic Nerve Decompression Surgery for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Is Not Effective and May Be Harmful. / Ischemic, Frank; Hooper, Frank; Kaufman, David; Newman, Nancy J.; Wilson, P. David; Zam, Z. Suzanne; Kennerdell, John; Tyutyunikov, Anna; Edwards, Russell; Goodglick, Todd; Lang, Deborah; Peele, Kimberly; Chung, Sophia; Mekelburg, Diana; Holds, John; Selhorst, John; Malton, Mark; Armstrong, Sonia; Mccracken, Yvonne; Benjamin, Eugene; Dellinger, Carol; Medlin, Traci Hunter; Kinsler, Barbara; Mcowen, Mike; Russell, Donna; Saunders, Timothy; Kosmorsky, Gregory; Kiss, Tina; Reinhard, Cate; Venne, Laura; Edgerton, Janet; Fecko, Tami; Hanson, Susannah; Kraus, Brian; Ross, Deborah; Tomsak, Nancy; Vargo, Pamela; Willis, Rufus; Feldon, Steven; Zimmerman, Kerry; Anderson, Kristin; Cortez, Richard; Deblanc, Karen; Hulse, Judy; Morales, Ronald B.; Nichols, Tracy; Reyes, Lillian; Rodarte Ochoa, Nadine; Romo, Daniel; Sadun, Alfredo; Steber, Mary; Walonker, Frances; Loupe, Donna; Coffman, Diana; Cole, Harvey; Wojno, Ted; Skarf, Barry; Wojtala, Colleen; Croswell, Mark; Gilroy, Wendy; Mageli, Christian; Mcdonald, Dena; Ponka, George; Tang, Rosa; Hamlin, Melissa; Curtis, Jewel; Forman, Jay; Hyde, Kenneth; Mack, Kirk; Tello, Portia; Arnold, Anthony; Cibener, Berniee; Acero, Melody; Ballenberg, Bobbi; Bolton, Anne; Goldberg, Robert; Gordon, Lynn; Heneghan, Michael; Krauss, Howard; Sanguinei, Jackie; Stalling, Robert; Yadegaran, Jenja; Cornblath, Wayne; Michael, Barbara; Campbell, Donna; Caudill, Cheryl; Nelson, Christine; Trobe, Jonathan; Johnson, Lenworth N.; Baker, Gaye; Cobb, Coy; Custer, Philip; Turner, Sharon; Wilson, Roy; Younge, Brian; Leavitt, Jacqueline; Nielsen, Rebecca; Allen, Jody; Eickhoff, Barbara; Garrity, James; Ladsten, Jacqueline; Lebarron, Kathleen; Link, Thomas P.; Rostvold, Jay; Weber, Karen; Felton, Warren; Boney, Tracy; Gabriel, Danielle; David, Daniel; Fendelander, Lahn; Geller, Daniel; Jordan, Timothy; Kim, Christian; Munger, Craig; Romandy, Anne; Sanborn, George; Schwartz, Bradley; Sheusi, Carl; Smith, Constance; Talley, Kathy; Thimmappa, Sandya; Eggenberger, Eric; Bickert, Suzanne; Granadier, Robert; Holliday, Sandra; Moore, Thomas; Varadarajan, Jaya; Friedman, Deborah; Jones, Patricia; Amin, Haris; Bersani, Thomas; Briglin, Cynthia; Fooks, James; Graham, Michael; James, Milton; Michalec, Gary; Nguyen, Hoang; Horton, Jonathan; Chang, Maeve; Aber, Lou Anne; Lindstrom, Erik; Seiff, Stuart; Guy, John; Francis, Amye; Hamed, Latif; Lessner, Alan; Mcdavid, Donna; Shamis, Diana; Goodwin, James; Lindeman, Martin E.; Putterman, Allen; Bobak, Phyllis; Baker, Robert; Beck, Judy; Cowen, David; Epstein, Avrom; Hanson, Michael; Scoggins, Toni; Rodavitch, Ann M.; Gore, Brenda; Blake, Andrea; Heroux, Michele; Kalsi, Rani; Krauch, Charlene; Millar, Mary Ann; Wolin, Mitchell; Brady, Rita Jean; Hansen, Regina; Briggs, Michael; Chalam, Karkarla V.; Danner, Barbara; Simons, Beverly; Stewart, Anne; Digre, Kathleen; Malmquist Webb, Lizbeth; Blackburn, Terrell; Baggaley, Susan; Anderson, Richard; Juarez, Charles; Kaye, Bonnie; Langer, Paul; Mishra, Aditya; Morris, Paula; Osborn, Sandra; Patel, Bhupendra; Priskos, Tessie; Staker, Sandra; Warner, Judith; Evans, Christine; Aylor, Allison; Childress, Carolyn; Dickerson, Helen; Fleming, Jane; Harris, Nomine; Hoyle, L. Sharon; Murphy, Ellen; Scott, James; Summerville, Karen; Terrell, Mariann; Tyler, Lillian; Linberg, John; Breen, Lenore; Michael, Michelle; Campbell, Charlene; Ellis, Brian; Groves, Nancy; Hobson, Robert; Mcgregor, Gordon; Shepherd, Laura; Cohn, Edward; Manatrey, Patricia; Casey, Sara; Johnson, John; Kronner, Coletti; Regan, Virginia; Streasick, Patricia; Kelman, Shalom; Elman, Michael; Rodavitch, Aim M.; Scherer, Roberta; Crawley, Barbara; Hiner, Cheryl; Howard, Lucy; Langenberg, Patricia; Lurye, Olga; Riedel, Sara; Sotos, Michelle; Spioch, Laureen; Starr, Joann; Urban, Judy; Waring, Mark; Everett, Donald; Dickersin, Kay; Mccarter, Robert; Seiff, Stuart R.
In: JAMA: The Journal of the American Medical Association, Vol. 273, No. 8, 02.1995, p. 625-632.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Optic Nerve Decompression Surgery for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Is Not Effective and May Be Harmful
AU - Ischemic, Frank
AU - Hooper, Frank
AU - Kaufman, David
AU - Newman, Nancy J.
AU - Wilson, P. David
AU - Zam, Z. Suzanne
AU - Kennerdell, John
AU - Tyutyunikov, Anna
AU - Edwards, Russell
AU - Goodglick, Todd
AU - Lang, Deborah
AU - Peele, Kimberly
AU - Chung, Sophia
AU - Mekelburg, Diana
AU - Holds, John
AU - Selhorst, John
AU - Malton, Mark
AU - Armstrong, Sonia
AU - Mccracken, Yvonne
AU - Benjamin, Eugene
AU - Dellinger, Carol
AU - Medlin, Traci Hunter
AU - Kinsler, Barbara
AU - Mcowen, Mike
AU - Russell, Donna
AU - Saunders, Timothy
AU - Kosmorsky, Gregory
AU - Kiss, Tina
AU - Reinhard, Cate
AU - Venne, Laura
AU - Edgerton, Janet
AU - Fecko, Tami
AU - Hanson, Susannah
AU - Kraus, Brian
AU - Ross, Deborah
AU - Tomsak, Nancy
AU - Vargo, Pamela
AU - Willis, Rufus
AU - Feldon, Steven
AU - Zimmerman, Kerry
AU - Anderson, Kristin
AU - Cortez, Richard
AU - Deblanc, Karen
AU - Hulse, Judy
AU - Morales, Ronald B.
AU - Nichols, Tracy
AU - Reyes, Lillian
AU - Rodarte Ochoa, Nadine
AU - Romo, Daniel
AU - Sadun, Alfredo
AU - Steber, Mary
AU - Walonker, Frances
AU - Loupe, Donna
AU - Coffman, Diana
AU - Cole, Harvey
AU - Wojno, Ted
AU - Skarf, Barry
AU - Wojtala, Colleen
AU - Croswell, Mark
AU - Gilroy, Wendy
AU - Mageli, Christian
AU - Mcdonald, Dena
AU - Ponka, George
AU - Tang, Rosa
AU - Hamlin, Melissa
AU - Curtis, Jewel
AU - Forman, Jay
AU - Hyde, Kenneth
AU - Mack, Kirk
AU - Tello, Portia
AU - Arnold, Anthony
AU - Cibener, Berniee
AU - Acero, Melody
AU - Ballenberg, Bobbi
AU - Bolton, Anne
AU - Goldberg, Robert
AU - Gordon, Lynn
AU - Heneghan, Michael
AU - Krauss, Howard
AU - Sanguinei, Jackie
AU - Stalling, Robert
AU - Yadegaran, Jenja
AU - Cornblath, Wayne
AU - Michael, Barbara
AU - Campbell, Donna
AU - Caudill, Cheryl
AU - Nelson, Christine
AU - Trobe, Jonathan
AU - Johnson, Lenworth N.
AU - Baker, Gaye
AU - Cobb, Coy
AU - Custer, Philip
AU - Turner, Sharon
AU - Wilson, Roy
AU - Younge, Brian
AU - Leavitt, Jacqueline
AU - Nielsen, Rebecca
AU - Allen, Jody
AU - Eickhoff, Barbara
AU - Garrity, James
AU - Ladsten, Jacqueline
AU - Lebarron, Kathleen
AU - Link, Thomas P.
AU - Rostvold, Jay
AU - Weber, Karen
AU - Felton, Warren
AU - Boney, Tracy
AU - Gabriel, Danielle
AU - David, Daniel
AU - Fendelander, Lahn
AU - Geller, Daniel
AU - Jordan, Timothy
AU - Kim, Christian
AU - Munger, Craig
AU - Romandy, Anne
AU - Sanborn, George
AU - Schwartz, Bradley
AU - Sheusi, Carl
AU - Smith, Constance
AU - Talley, Kathy
AU - Thimmappa, Sandya
AU - Eggenberger, Eric
AU - Bickert, Suzanne
AU - Granadier, Robert
AU - Holliday, Sandra
AU - Moore, Thomas
AU - Varadarajan, Jaya
AU - Friedman, Deborah
AU - Jones, Patricia
AU - Amin, Haris
AU - Bersani, Thomas
AU - Briglin, Cynthia
AU - Fooks, James
AU - Graham, Michael
AU - James, Milton
AU - Michalec, Gary
AU - Nguyen, Hoang
AU - Horton, Jonathan
AU - Chang, Maeve
AU - Aber, Lou Anne
AU - Lindstrom, Erik
AU - Seiff, Stuart
AU - Guy, John
AU - Francis, Amye
AU - Hamed, Latif
AU - Lessner, Alan
AU - Mcdavid, Donna
AU - Shamis, Diana
AU - Goodwin, James
AU - Lindeman, Martin E.
AU - Putterman, Allen
AU - Bobak, Phyllis
AU - Baker, Robert
AU - Beck, Judy
AU - Cowen, David
AU - Epstein, Avrom
AU - Hanson, Michael
AU - Scoggins, Toni
AU - Rodavitch, Ann M.
AU - Gore, Brenda
AU - Blake, Andrea
AU - Heroux, Michele
AU - Kalsi, Rani
AU - Krauch, Charlene
AU - Millar, Mary Ann
AU - Wolin, Mitchell
AU - Brady, Rita Jean
AU - Hansen, Regina
AU - Briggs, Michael
AU - Chalam, Karkarla V.
AU - Danner, Barbara
AU - Simons, Beverly
AU - Stewart, Anne
AU - Digre, Kathleen
AU - Malmquist Webb, Lizbeth
AU - Blackburn, Terrell
AU - Baggaley, Susan
AU - Anderson, Richard
AU - Juarez, Charles
AU - Kaye, Bonnie
AU - Langer, Paul
AU - Mishra, Aditya
AU - Morris, Paula
AU - Osborn, Sandra
AU - Patel, Bhupendra
AU - Priskos, Tessie
AU - Staker, Sandra
AU - Warner, Judith
AU - Evans, Christine
AU - Aylor, Allison
AU - Childress, Carolyn
AU - Dickerson, Helen
AU - Fleming, Jane
AU - Harris, Nomine
AU - Hoyle, L. Sharon
AU - Murphy, Ellen
AU - Scott, James
AU - Summerville, Karen
AU - Terrell, Mariann
AU - Tyler, Lillian
AU - Linberg, John
AU - Breen, Lenore
AU - Michael, Michelle
AU - Campbell, Charlene
AU - Ellis, Brian
AU - Groves, Nancy
AU - Hobson, Robert
AU - Mcgregor, Gordon
AU - Shepherd, Laura
AU - Cohn, Edward
AU - Manatrey, Patricia
AU - Casey, Sara
AU - Johnson, John
AU - Kronner, Coletti
AU - Regan, Virginia
AU - Streasick, Patricia
AU - Kelman, Shalom
AU - Elman, Michael
AU - Rodavitch, Aim M.
AU - Scherer, Roberta
AU - Crawley, Barbara
AU - Hiner, Cheryl
AU - Howard, Lucy
AU - Langenberg, Patricia
AU - Lurye, Olga
AU - Riedel, Sara
AU - Sotos, Michelle
AU - Spioch, Laureen
AU - Starr, Joann
AU - Urban, Judy
AU - Waring, Mark
AU - Everett, Donald
AU - Dickersin, Kay
AU - Mccarter, Robert
AU - Seiff, Stuart R.
PY - 1995/2
Y1 - 1995/2
N2 - 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). —The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single-masked, multicenter trial. —Twenty-five US clinical centers. —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. —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. —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. —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. —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.
AB - 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). —The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single-masked, multicenter trial. —Twenty-five US clinical centers. —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. —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. —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. —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. —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.
UR - http://www.scopus.com/inward/record.url?scp=0028910230&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0028910230&partnerID=8YFLogxK
U2 - 10.1001/jama.273.8.625
DO - 10.1001/jama.273.8.625
M3 - Article
C2 - 7844872
AN - SCOPUS:0028910230
VL - 273
SP - 625
EP - 632
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
SN - 0098-7484
IS - 8
ER -