The early treatment for retinopathy of prematurity study: Structural findings at age 2 years

William V. Good, Robert J. Hardy, Velma Dobson, Earl A. Palmer, Dale L. Phelps, Michelle Quintos, Betty Tung, Ashima Madan, M. Bethany Ball, Patricia N. Hartsell, Dottie Inguillo, Michael Gaynon, Deborah Alcorn, Donna Ornitz, Judith Gancasz, David Durand, Terri Slagle, Gordon Smith, Michael Shapiro, Yesenia GarciaMaria Genio, Jeffrey N. Bloom, Lawrence Kaufman, Wico Waikwan Lai, Marilyn Miller, Daniel Neely, Elizabeth A. Hynes, James Lemons, David Plager, Naval Sondhi, Derek Sprunger, Paul J. Rychwalski, Greg K. Whittington, Peggy H. Fishman, Robert A. Gordon, Deborah S. Neff, Douglas B. Babel, James G. Diamond, William L. Gill, Scott M. Steidl, Kelly A. Hutcheson, Kevin Powdrill, Eric Jones, Mark W. Preslan, Michael X. Repka, Jennifer A. Shepard, Pamela Donahue, Susan W. Aucott, Mary Louise Z. Collins, Maureen M. Gilmore, James T. Handa, Cynthia H. Cole, Deborah VanderVeen, Terri Mansfield, Brenda MacKinnon, Anthony Fraioli, O'ine McCabe, Robert Peterson, David Hunter, Sarah MacKinnon, Rhiannon Johnson, Mariette Tyedmers, John Baker, Krist Cumming, Pat Manatrey, Antonio Capone, Edward O'Malley, Rajesh Rao, John Roarty, Michael Trese, George Williams, Stephen P. Christiansen, Sally Cook, Ann Holleschau, C. Gail Summers, Bradley V. Davitt, Linda Breuer, Oscar Cruz, William Keenan, Greg Mantych, Gregg Lueder, Sharon Freedman, David Wallace, Lori Hutchins Parkman, Sarah Jones, Laura Enyedi, James D. Reynolds, Kristine Ziemann, George P. Albert, Steven Awner, Rita Ryan, Pamela Ann Weber, Marc Horowitz, Cherylene Behrendt, Natalie Dweck, Richard Koty, Edmund LaGamma, John Flynn, Thomas C. Lee, Osode Coki, Michael Chiang, Steven Kane, Richard Polin, 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, Leandro Cordero, Richard Golden, Richard Hertle, Richard McClead, Mary Lou McGregor, R. Michael Siatkowski, Lisa Ogilbee, Cheryl Harris, Reagan H. Bradford, Robert E. Leonard, Mary Anne McCaffree, David T. Wheeler, Nancy Dolphin, Ann Stout, Brian Nichols, David Epley, Graham E. Quinn, Jamie G. Koh, Soraya Abbasi, Jane C. Edmond, Brian J. Forbes, Albert M. Maguire, Monte D. Mills, Terri L. Young, Stephanie Davidson, Kenneth Cheng, Judith Jones, Robert Bergren, Beverly Brozanski, Bernard Doft, Louis Lobes, Karl Olsen, Richard A. Saunders, Linda Stevens, M. Millicent Peterseim, Edward Wilson, Dilip Purohit, David K. Coats, Michele L. Parker, Maria Castanes, Evelyn A. Paysee, Kimberly G. Yen, Joseph Garcia-Prats, W. A.J. Van Heuven, Yolanda Trigo, James C. MacDonald, Robert Hoffman, Susan Bracken, Paul Bernstein, Jerald King, Michael Teske, Maryann Redford, Richard L. Mowery, Donald F. Everett, Claudia Pedroza, Gordon Tsai, John Connett, Edward F. Donovan, Argye Hillis, Jonathan M. Holmes, Joseph M. Miller, Carol R. Taylor, Charles Barr

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Abstract

Objective: To determine whether earlier treatment of high-risk, prethreshold retinopathy of prematurity (ROP) improves retinal structural outcome at 2 years of age. Methods: Infants with bilateral high-risk prethreshold ROP had one eye randomly assigned to treatment with peripheral retinal ablation. The fellow eye was managed conventionally, and either treated at threshold ROP or observed if threshold was never reached. In patients with asymmetrical disease, the high-risk, prethreshold eye was randomised to earlier treatment or to conventional management. At 2 years of age, children were examined comprehensively by certified ophthalmologists to determine structural outcomes for their eyes. For the purposes of this study, an unfavourable structural outcome was defined as (1) a posterior retinal fold involving the macula, (2) a retinal detachment involving the macula or (3) retrolental tissue or "mass" obscuring the view of the posterior pole. Results of the 2-year examination were compared with those from the 9 months examination. Results: Data were available on 339 of 374 (90.6%) surviving children. Unfavourable structural outcomes were reduced from 15.4% in conventionally managed eyes to 9.1% in earlier-treated eyes (p = 0.002) at 2 years of age. Ophthalmic side effects (excluding retinal structure) from the ROP or its treatment were similar in the earlier-treated eyes and the conventionally managed eyes. Conclusion: The benefit of earlier treatment of high-risk prethreshold ROP on retinal structure endures to 2 years of age, and is not counterbalanced by any known side effect caused by earlier intervention. Earlier treatment improves the chance for long-term favourable retinal structural outcome in eyes with high-risk prethreshold ROP. Long-term follow-up is planned to determine structural and functional outcomes at 6 years of age.

Original languageEnglish
Pages (from-to)1378-1382
Number of pages5
JournalBritish Journal of Ophthalmology
Volume90
Issue number11
DOIs
StatePublished - Nov 2006

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