Final visual acuity results in the early treatment for retinopathy of prematurity study
Early Treatment for Retinopathy of Prematurity Cooperative Group, William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Betty Tung, Maryann Redford, Ashima Madan, M Bethany Ball, Judith Y Hall, William V Good, Judith Gancasz, David Durand, Terri Slagle, Gordon Smith, Michael Shapiro, Nydia Santiago, Rama Bhat, Lawrence Kaufman, Marilyn Miller, David Mittelman, Daniel Neely, Elizabeth A Hynes, David Plager, Charles C Barr, Michelle Bottorff, Greg K Whittington, Peggy H Fishman, Paul J Rychwalski, Robert A Gordon, Deborah S Neff, James G Diamond, William L Gill, Mark W Preslan, Kevin Powdrill, Kelly A Hutcheson, Eric Jones, Scott M Steidl, Joanne Marie Waeltermann, Michael X Repka, Jennifer A Shepard, Pamela Donahue, Susan W Aucott, Mary Louise Z Collins, Maureen M Gilmore, James T Handa, Deborah K VanderVeen, Theresa Mansfield, Brenda MacKinnon, Cynthia H Cole, Anthony Fraioli, David Hunter, O'Ine McCabe, Robert Petersen, Mitchell Brent Strominger, Sarah MacKinnon, Rhiannon Johnson, Mariette Tyedmers, John Baker, Kristi Cumming, Pat Manatrey, Mary P Bedard, Renato Casabar, Antonio Capone, Edward O'Malley, Rajesh Rao, John Roarty, Michael Trese, George Williams, C Gail Summers, Sally Cook, Ann Holleschau, Molly Maxwell, Stephen P Christiansen, David Brasel, Bradley V Davitt, Linda Breuer, Oscar Cruz, William Keenan, Greg Mantych, Gregg Lueder, Sharon Freedman, David Wallace, Lori Hutchins Parkman, Sarah K Jones, Laura Enyedi, Ricki F Goldstein, James D Reynolds, Kristine Ziemann, George P Albert, Steven Awner, Rita Ryan, Pamela Ann Weber, Marc Horowitz, Cherylene Behrendt, Adriann Combs, Natalie Dweck, Richard Koty, Edmund LaGamma, Maury Marmor, John Flynn, Osode Coki, Michael Chiang, Steven Kane, Alfred Krauss, Thomas C Lee, Robert F Lopez, Richard Polin, Dale L Phelps, Cassandra Horihan, Jane Phillips, Gary Markowitz, Walter Merriam, Leon-Paul Noel, Donald Tingley, Matthew Gearinger, Gary L Rogers, Don Bremer, Rae Fellows, Sharon Klamfoth, Brian Arthur, Cybil Bean Cassady, Richard Golden, Mary Lou McGregor, R Michael Siatkowski, Cheryl Harris, Vanessa Yazdanipanah, Reagan H Bradford, Robert E Leonard, Mary Anne McCaffree, David T Wheeler, Nancy Dolphin, Earl A Palmer, Ann Stout, Brian Nichols, David Epley, Graham E Quinn, Jamie G Koh, Marianne Letterio, Soraya Abbasi, Jane C Edmond, Brian J Forbes, Albert M Maguire, Monte D Mills, Eric A Pierce, Terri L Young, Stephanie Davidson, Kenneth Cheng, Janice Kelchner-Cheng, Judith Jones, Robert Bergren, Bernard Doft, Louis Lobes, Karl Olsen, Richard A Saunders, Dilip Purohit, Linda Stevens, Kimberly Lenhart, David K Coats, Michele L Parker, Maria Castanes, Alison Brown, Jane Edmond, Joseph Garcia-Prats, Eric Holz, W Scott Jarriel, Karen Johnson, George Mandy, Evelyn A Paysee, A Melinda Rainey, Paul G Steinkuller, Kimberly G Yen, John P Stokes, Yolanda Trigo, Alice K Gong, W A J van Heuven, Robert Hoffman, Susan Bracken, Deborah Y Harrison, Paul Bernstein, Jerald King, Michael Teske, Maryann Redford, Richard L Mowery, Donald F Everett, William V Good, Michelle Quintos, Robert J Hardy, Betty Tung, Dejian Lai, Gordon Tsai, Velma Dobson, Deborah D Hargadon, Jeffrey Wood, Graham E Quinn, Erin M Harvey, John Connett, Edward F Donovan, Argye Hillis, Jonathan M Holmes, Joseph M Miller, Carol R Taylor, William V Good, Robert J Hardy, Maryann Redford, Velma Dobson, Earl A Palmer, Dale L Phelps, Maryann Redford, W A J van Heuven, Charles Barr, Michael Gaynon, Michael Shapiro, David Wallace, Bradley V Davitt, Rae Fellows, Judith Jones, Kristi Cumming, Deborah S Neff, Jennifer A Shepard, Nancy Dolphin, William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Michelle Quintos, Betty Tung, Early Treatment for Retinopathy of Prematurity Cooperative Group, William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Betty Tung, Maryann Redford, Ashima Madan, M Bethany Ball, Judith Y Hall, William V Good, Judith Gancasz, David Durand, Terri Slagle, Gordon Smith, Michael Shapiro, Nydia Santiago, Rama Bhat, Lawrence Kaufman, Marilyn Miller, David Mittelman, Daniel Neely, Elizabeth A Hynes, David Plager, Charles C Barr, Michelle Bottorff, Greg K Whittington, Peggy H Fishman, Paul J Rychwalski, Robert A Gordon, Deborah S Neff, James G Diamond, William L Gill, Mark W Preslan, Kevin Powdrill, Kelly A Hutcheson, Eric Jones, Scott M Steidl, Joanne Marie Waeltermann, Michael X Repka, Jennifer A Shepard, Pamela Donahue, Susan W Aucott, Mary Louise Z Collins, Maureen M Gilmore, James T Handa, Deborah K VanderVeen, Theresa Mansfield, Brenda MacKinnon, Cynthia H Cole, Anthony Fraioli, David Hunter, O'Ine McCabe, Robert Petersen, Mitchell Brent Strominger, Sarah MacKinnon, Rhiannon Johnson, Mariette Tyedmers, John Baker, Kristi Cumming, Pat Manatrey, Mary P Bedard, Renato Casabar, Antonio Capone, Edward O'Malley, Rajesh Rao, John Roarty, Michael Trese, George Williams, C Gail Summers, Sally Cook, Ann Holleschau, Molly Maxwell, Stephen P Christiansen, David Brasel, Bradley V Davitt, Linda Breuer, Oscar Cruz, William Keenan, Greg Mantych, Gregg Lueder, Sharon Freedman, David Wallace, Lori Hutchins Parkman, Sarah K Jones, Laura Enyedi, Ricki F Goldstein, James D Reynolds, Kristine Ziemann, George P Albert, Steven Awner, Rita Ryan, Pamela Ann Weber, Marc Horowitz, Cherylene Behrendt, Adriann Combs, Natalie Dweck, Richard Koty, Edmund LaGamma, Maury Marmor, John Flynn, Osode Coki, Michael Chiang, Steven Kane, Alfred Krauss, Thomas C Lee, Robert F Lopez, Richard Polin, Dale L Phelps, Cassandra Horihan, Jane Phillips, Gary Markowitz, Walter Merriam, Leon-Paul Noel, Donald Tingley, Matthew Gearinger, Gary L Rogers, Don Bremer, Rae Fellows, Sharon Klamfoth, Brian Arthur, Cybil Bean Cassady, Richard Golden, Mary Lou McGregor, R Michael Siatkowski, Cheryl Harris, Vanessa Yazdanipanah, Reagan H Bradford, Robert E Leonard, Mary Anne McCaffree, David T Wheeler, Nancy Dolphin, Earl A Palmer, Ann Stout, Brian Nichols, David Epley, Graham E Quinn, Jamie G Koh, Marianne Letterio, Soraya Abbasi, Jane C Edmond, Brian J Forbes, Albert M Maguire, Monte D Mills, Eric A Pierce, Terri L Young, Stephanie Davidson, Kenneth Cheng, Janice Kelchner-Cheng, Judith Jones, Robert Bergren, Bernard Doft, Louis Lobes, Karl Olsen, Richard A Saunders, Dilip Purohit, Linda Stevens, Kimberly Lenhart, David K Coats, Michele L Parker, Maria Castanes, Alison Brown, Jane Edmond, Joseph Garcia-Prats, Eric Holz, W Scott Jarriel, Karen Johnson, George Mandy, Evelyn A Paysee, A Melinda Rainey, Paul G Steinkuller, Kimberly G Yen, John P Stokes, Yolanda Trigo, Alice K Gong, W A J van Heuven, Robert Hoffman, Susan Bracken, Deborah Y Harrison, Paul Bernstein, Jerald King, Michael Teske, Maryann Redford, Richard L Mowery, Donald F Everett, William V Good, Michelle Quintos, Robert J Hardy, Betty Tung, Dejian Lai, Gordon Tsai, Velma Dobson, Deborah D Hargadon, Jeffrey Wood, Graham E Quinn, Erin M Harvey, John Connett, Edward F Donovan, Argye Hillis, Jonathan M Holmes, Joseph M Miller, Carol R Taylor, William V Good, Robert J Hardy, Maryann Redford, Velma Dobson, Earl A Palmer, Dale L Phelps, Maryann Redford, W A J van Heuven, Charles Barr, Michael Gaynon, Michael Shapiro, David Wallace, Bradley V Davitt, Rae Fellows, Judith Jones, Kristi Cumming, Deborah S Neff, Jennifer A Shepard, Nancy Dolphin, William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Michelle Quintos, Betty Tung
Abstract
Objective: To compare visual acuity at 6 years of age in eyes that received early treatment for high-risk prethreshold retinopathy of prematurity (ROP) with conventionally managed eyes.
Methods: Infants with symmetrical, high-risk prethreshold ROP (n = 317) had one eye randomized to earlier treatment at high-risk prethreshold disease and the other eye managed conventionally, treated if ROP progressed to threshold severity. For asymmetric cases (n = 84), the high-risk prethreshold eye was randomized to either early treatment or conventional management. The main outcome measure was ETDRS visual acuity measured at 6 years of age by masked testers. Retinal structure was assessed as a secondary outcome.
Results: Analysis of all subjects with high-risk prethreshold ROP showed no statistically significant benefit for early treatment (24.3% vs 28.6% [corrected] unfavorable outcome; P = .15). Analysis of 6-year visual acuity results according to the Type 1 and 2 clinical algorithm showed a benefit for Type 1 eyes (25.1% vs 32.8%; P = .02) treated early but not Type 2 eyes (23.6% vs 19.4%; P = .37). Early-treated eyes showed a significantly better structural outcome compared with conventionally managed eyes (8.9% vs 15.2% unfavorable outcome; P < .001), with no greater risk of ocular complications.
Conclusions: Early treatment for Type 1 high-risk prethreshold eyes improved visual acuity outcomes at 6 years of age. Early treatment for Type 2 high-risk prethreshold eyes did not. Application to Clinical Practice Type 1 eyes, not Type 2 eyes, should be treated early. These results are particularly important considering that 52% of Type 2 high-risk prethreshold eyes underwent regression of ROP without requiring treatment. Trial Registration clinicaltrials.gov Identifier: NCT00027222.
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Source: PubMed