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.
- CRYO-ROP, Cryotherapy for Retinopathy Of Prematurity
- ETROP, Early Treatment for Retinopathy Of Prematurity
- ROP, retinopathy of prematurity
Statistics from Altmetric.com
Published Online First 16 August 2006
Funding: This study was supported by cooperative agreements (5U10 EY12471 and 5U10 EY12472) with the National Eye Institute of the National Institutes of Health, US Department of Health and Human Services, Bethesda, Maryland.
ETROP study investigators. Writing Committee: chair: William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Michelle Quintos, Betty Tung. Stanford Center, Palo Alto, California, USA: Lucille Packard Children’s Hospital, Stanford University: principal investigator: Ashima Madan; study center coordinators: M Bethany Ball, Patricia N Hartsell, Dottie Inguillo; coinvestigators: Michael Gaynon, Deborah Alcorn, William V Good, Donna Ornitz. San Francisco Center, San Francisco, California, USA: California Pacific Medical Center, Oakland Children’s Hospital, University of California, San Francisco Medical Center: principal investigator: William V Good; study center coordinator: Judith Gancasz; coinvestigators: David Durand, Terri Slagle, Gordon Smith. Chicago Center, Chicago, Illinois, USA: University of Illinois at Chicago Hospital and Medical Center: principal investigator: Michael Shapiro; study centre coordinators: Yesenia Garcia, Maria Genio; coinvestigators: Jeffrey N Bloom, Lawrence Kaufman, Wico Waikwan Lai, Marilyn Miller. Indianapolis Center, Indianapolis, Indiana, USA: Indiana University School of Medicine, James Whitcomb Riley Hospital for Children, Indiana University Hospital, Wishard Memorial Hospital, Methodist Hospital, Community Hospitals of Indianapolis: principal investigator: Daniel Neely; study centre coordinator: Elizabeth A Hynes; coinvestigators: James Lemons, David Plager, Naval Sondhi, Derek Sprunger. Louisville Center, Louisville, Kentucky, USA: Kosair Children’s Hospital, University of Louisville Hospital: principal investigator: Paul J Rychwalski; study centre coordinator: Greg K Whittington; coinvestigator: Peggy H Fishman. New Orleans Center, New Orleans, Louisiana, USA: Tulane University Medical Center, Medical Center of Louisiana at New Orleans: principal investigator: Robert A Gordon; study centre coordinator: Deborah S Neff; coinvestigators: Douglas B Babel, James G Diamond, William L Gill. Baltimore G Center, Baltimore, Maryland, USA: University of Maryland Medical Systems, Mercy Medical Center, Franklin Square Hospital: principal investigator: Scott M Steidl; co-principal investigator: Kelly A Hutcheson; study centre coordinator: Kevin Powdrill; coinvestigators: Eric Jones, Mark W Preslan. Baltimore R Center, Baltimore, Maryland, USA: Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital, Greater Baltimore Medical Center, St Joseph Medical Center: principal investigator: Michael X Repka; study centre coordinators: Jennifer A Shepard, Pamela Donahue; coinvestigators: Susan W Aucott, Mary Louise Z Collins, Maureen M Gilmore, James T Handa. Boston Center, Boston, Massachusetts, USA: Beth Israel Deaconess Medical Center, Children’s Hospital, New England Medical Center, Brigham and Women’s Hospital: principal investigator: Cynthia H Cole; co-principal investigator: Deborah VanderVeen; study centre coordinators: Terri Mansfield, Brenda MacKinnon; coinvestigators: Anthony Fraioli, O’ine McCabe, Robert Peterson, David Hunter; orthoptists: Sarah MacKinnon, Rhiannon Johnson, Mariette Tyedmers. Detroit Center, Detroit, Michigan, USA: William Beaumont Hospital, Children’s Hospital of Michigan, St John’s Hospital Detroit: principal investigator: John Baker; study centre coordinators: Kristi Cumming, Pat Manatrey; coinvestigators: Antonio Capone, Edward O’Malley, Rajesh Rao, John Roarty, Michael Trese, George Williams. Minneapolis Center, Minneapolis, Minnesota, USA: Fairview University Medical Center, Children’s Health Care, Minneapolis, Hennepin County Medical Center: principal investigator: Stephen P Christiansen; study centre coordinators: Sally Cook, Ann Holleschau; coinvestigator: C Gail Summers. St Louis Center, St Louis, Missouri, USA: Cardinal Glennon Children’s Medical Center, St Mary’s Health Center: principal investigator: Bradley V Davitt; study centre coordinator: Linda Breuer; coinvestigators: Oscar Cruz, William Keenan, Greg Mantych, Gregg Lueder. North Carolina Center, Durham, North Carolina, USA: Duke University Medical Center: principal investigator: Sharon Freedman; co-principal investigator: David Wallace; study centre coordinators: Lori Hutchins Parkman, Sarah Jones; coinvestigator: Laura Enyedi. Buffalo Center, Buffalo, New York, USA: Women’s and Children’s Hospital of Buffalo, Sisters of Charity Hospital: principal investigator: James D Reynolds, study centre coordinator: Kristine Ziemann; coinvestigators: George P Albert, Steven Awner; Rita Ryan. Long Island/Westchester Center, New York, USA: Stony Brook University Hospital, Westchester Medical Center: principal investigator: Pamela Ann Weber; co-principal investigator: Marc Horowitz; study centre coordinators: Cherylene Behrendt, Natalie Dweck; coinvestigators: Richard Koty, Edmund LaGamma. New York Centre, New York, New York, USA: New York Presbyterian Hospital, Columbia Campus, New York Presbyterian Hospital, Cornell Campus: principal investigator: John Flynn; co-principal investigator: Thomas C Lee; study centre coordinator: Osode Coki; coinvestigators: Michael Chiang, Steven Kane, Richard Polin. Rochester/Syracuse Centre, New York, USA: University of Rochester Medical Center, Crouse-Irving Memorial Hospital: principal investigator: Dale L Phelps; study centre coordinators: Cassandra Horihan, Jane Phillips; coinvestigators: Gary Markowitz, Walter Merriam, Leon-Paul Noel, Donald Tingley, Matthew Gearinger. Columbus Centre, Columbus, Ohio, USA: Columbus Children’s Hospital: principal investigator: Gary L Rogers; co-principal investigator: Don Bremer; study centre coordinators: Rae Fellows; Sharon Klamfoth; coinvestigators: Brian Arthur, Cybil Bean Cassady, Leandro Cordero, Richard Golden, Richard Hertle, Richard McClead, Mary Lou McGregor. Oklahoma City Centre, Oklahoma City, Oklahoma, USA: Children’s Hospital of Oklahoma, University of Oklahoma, Dean A McGee Eye Institute: principal investigator: R Michael Siatkowski; study centre coordinators: Lisa Ogilbee, Cheryl Harris; coinvestigators: Reagan H Bradford, Robert E Leonard, Mary Anne McCaffree. Portland Centre, Portland, Oregon, USA: Doernbecher Children’s Hospital at Oregon Health and Science University, Legacy Emanuel Children’s Hospital, Providence St Vincent’s Hospital: principal investigator: David T Wheeler; study centre coordinator: Nancy Dolphin; coinvestigators: Earl A Palmer, Ann Stout, Brian Nichols, David Epley. Philadelphia Centre, Philadelphia, Pennsylvania, USA: The Children’s Hospital of Philadelphia, The Hospital of the University of Pennsylvania, Pennsylvania Hospital: principal investigator: Graham E Quinn; study centre coordinator: Jamie G Koh; coinvestigators: Soraya Abbasi, Jane C Edmond, Brian J Forbes, Albert M Maguire, Monte D Mills, Terri L Young, Stephanie Davidson. Pittsburgh Centre, Pittsburgh, Pennsylvania, USA: Magee-Women’s Hospital: principal investigator: Kenneth Cheng; study centre coordinator: Judith Jones; coinvestigators: Robert Bergren, Beverly Brozanski, Bernard Doft, Louis Lobes, Karl Olsen. Charleston Centre, Charleston, South Carolina, USA: Medical University of South Carolina: principal investigator: Richard A Saunders; study centre coordinator: Linda Stevens; coinvestigators: M Millicent Peterseim, M Edward Wilson, Dilip Purohit. Houston Center, Houston, Texas, USA: Baylor College of Medicine, Texas Children’s Hospital, Texas Woman’s Hospital, Ben Taub General Hospital: principal investigator: David K Coats; study centre coordinators: Michele L Parker, Maria Castanes; coinvestigators: Evelyn A Paysee, Kimberly G Yen, Joseph Garcia-Prats. San Antonio Centre, San Antonio, Texas, USA: University Hospital, Christus Santa Rosa Children’s Hospital: principal investigator: WAJ van Heuven; study centre coordinator: Yolanda Trigo; coinvestigator: James C MacDonald. Salt Lake City Centre, Salt Lake City, Utah, USA: University of Utah Health Science Center, Primary Children’s Medical Center: principal investigator: Robert Hoffman,; study centre coordinator: Susan Bracken; coinvestigators: Paul Bernstein, Jerald King, Michael Teske. National Eye Institute, Bethesda, Maryland, USA: programme officer: Maryann Redford (June 2001–present), Richard L Mowery (October 2000–May 2001), Donald F Everett (September 1999–September 2000). Study Headquarters: Smith-Kettlewell Eye Research Institute, San Francisco, California, USA: principal investigator: William V Good; project coordinator: Michelle Quintos. Coordinating centre: School of Public Health, Coordinating Center for Clinical Trials, University of Texas Health Science Center, Houston, Texas, USA: principal investigator: Robert J Hardy; project manager: Betty Tung; coinvestigator: Claudia Pedroza; coordinating centre staff: Gordon Tsai. Vision Testing Centre: University of Arizona, School of Medicine, Tucson, Arizona, USA: principal investigator: Velma Dobson; coinvestigator: Graham E Quinn. Data and Safety Monitoring Committee: chair: John Connett; members: Edward F Donovan, Argye Hillis, Jonathan M Holmes, Joseph M Miller, Carol R Taylor; ex-officio members: William V Good, Robert J Hardy, Maryann Redford. Executive Committee: permanent members: chair: William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Maryann Redford. Executive Committee: elected members: WAJ van Heuven (2000–1, 2004–6), Charles Barr (2001–2), Michael Gaynon (2002–3), Michael Shapiro (2003–4), Rae Fellows (2000–1, 2006–present), Judith Jones (2001–2), Kristi Cumming (2002–3), Deborah S Neff (2003–4), Jennifer A Shepard (2004–6), Nancy Dolphin (2006–present). Editorial Committee: chair: William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Michelle Quintos, Betty Tung.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.