The Early Treatment for Retinopathy of Prematurity Study (ETROP)
NCT ID: NCT00027222
Last Updated: 2005-06-24
Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
INTERVENTIONAL
2001-10-31
Brief Summary
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Detailed Description
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Two concerns emerged from the CRYO-ROP extensive study on the natural history of ROP and treatment of threshold ROP. The first of these is failure of peripheral retinal ablation to eliminate all, or nearly all cases, of retinal detachment due to ROP. In the CRYO-ROP Study, 26 percent of eyes with threshold disease in zone II and 78 percent of eyes with zone I threshold disease had an unfavorable structural outcome despite treatment. The second concern is that most children who developed threshold ROP disease had visual acuity worse than 20/40 even if the eye had a favorable structural outcome.
Since no other treatment has yet been shown to be effective in preventing blindness from ROP, retinal ablation remains the treatment of choice. The ETROP Study will test whether earlier treatment is more effective than treatment at threshold in improving functional (visual acuity) outcome following ROP, as well as determining whether earlier treatment decreases the probability of an unfavorable structural outcome.
Earlier treatment is defined as retinal ablation administered to the avascular retina when an eye reaches high risk prethreshold retinopathy of prematurity (ROP). Prethreshold indicates any Zone I ROP; or Zone II stage 2 with plus disease, or stage 3; or Zone II with less than 5 contiguous or 8 cumulative clock hours of stage 3 ROP with plus disease. Recognizing that a substantial number of eyes undergo spontaneous resolution of ROP, eyes will be randomized to early treatment only when high risk for an unfavorable visual acuity outcome is identified. High risk will be determined using a risk model analysis program based on longitudinal natural history data obtained from the CRYO-ROP study. This model integrates risk factors to assign a risk of progression to blindness without treatment. These factors include birth weight, gestational age, ethnicity, singleton/multiple status, outborn status, Zone on first exam, severity of ROP and rate of progression of ROP. When an infant develops prethreshold ROP and greater than or equal to 15 percent risk of unfavorable outcome, randomization to early treatment of one eye will occur. Visual acuity outcome will be measured by masked observers after wearing best correction using the Teller Acuity Card Procedure at 9 months corrected age.
Conditions
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Study Design
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TREATMENT
Interventions
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retinal ablation
Eligibility Criteria
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Inclusion Criteria
0 Years
42 Days
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Principal Investigators
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William V. Good, M.D.
Role: STUDY_CHAIR
Smith-Kettlewell Eye Research Institute
Locations
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Stanford University School of Medicine
Palo Alto, California, United States
Smith-Kettlewell Eye Research Institute
San Francisco, California, United States
UIC Eye Center Department of Ophthalmology and Visual Sciences The Lions of Illinois Eye Research Institute
Chicago, Illinois, United States
Indiana University Department of Pediatrics
Indianapolis, Indiana, United States
University of Louisville Health Sciences Center
Louisville, Kentucky, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
The Zanvyl Krieger Children's Eye Center
Baltimore, Maryland, United States
Tufts University School of Medicine Department of Pediatrics
Boston, Massachusetts, United States
Pediatric Ophthalmology Associates, PC
Dearborn, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cardinal Glennon Children's Hospital Neonatology Office
St Louis, Missouri, United States
The Children's Hospital of Buffalo Department of Ophthalmology
Buffalo, New York, United States
Edward S. Harkness Eye Institute
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Eastern Long Island Retina Associate
Shirley, New York, United States
Duke University Eye Center
Durham, North Carolina, United States
Columbus Children's Hospital
Columbus, Ohio, United States
The Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Oregon Health Sciences University Casey Eye Institute
Portland, Oregon, United States
The Children's Hospital of Philadelphia Division of Pediatric Ophthalmology
Philadelphia, Pennsylvania, United States
Magee-Women's Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine Feigin Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
John Moran Eye Center University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Countries
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References
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Wallace DK, Bremer DL, Good WV, Fellows R, Summers CG, Tung B, Hardy RJ. Correlation of recognition visual acuity with posterior retinal structure in advanced retinopathy of prematurity. Arch Ophthalmol. 2012 Dec;130(12):1512-6. doi: 10.1001/archophthalmol.2012.2118.
Good WV, Hardy RJ, Wallace DK, Bremer D, Rogers DL, Siatkowski RM, De Becker I, Summers CG, Fellows R, Tung B, Palmer EA. beta-Blocking and racial variation in the severity of retinopathy of prematurity. Arch Ophthalmol. 2012 Jan;130(1):117-8. doi: 10.1001/archopht.130.1.117. No abstract available.
VanderVeen DK, Bremer DL, Fellows RR, Hardy RJ, Neely DE, Palmer EA, Rogers DL, Tung B, Good WV; Early Treatment for Retinopathy of Prematurity Cooperative Group. Prevalence and course of strabismus through age 6 years in participants of the Early Treatment for Retinopathy of Prematurity randomized trial. J AAPOS. 2011 Dec;15(6):536-40. doi: 10.1016/j.jaapos.2011.07.017.
Early Treatment for Retinopathy of Prematurity Cooperative Group; Dobson V, Quinn GE, Summers CG, Hardy RJ, Tung B, Good WV. Grating visual acuity results in the early treatment for retinopathy of prematurity study. Arch Ophthalmol. 2011 Jul;129(7):840-6. doi: 10.1001/archophthalmol.2011.143.
Quinn GE, Dobson V, Hardy RJ, Tung B, Palmer EA, Good WV; Early Treatment for Retinopathy of Prematurity Cooperative Group. Visual field extent at 6 years of age in children who had high-risk prethreshold retinopathy of prematurity. Arch Ophthalmol. 2011 Feb;129(2):127-32. doi: 10.1001/archophthalmol.2010.360.
Christiansen SP, Dobson V, Quinn GE, Good WV, Tung B, Hardy RJ, Baker JD, Hoffman RO, Reynolds JD, Rychwalski PJ, Shapiro MJ; Early Treatment for Retinopathy of Prematurity Cooperative Group. Progression of type 2 to type 1 retinopathy of prematurity in the Early Treatment for Retinopathy of Prematurity Study. Arch Ophthalmol. 2010 Apr;128(4):461-5. doi: 10.1001/archophthalmol.2010.34.
Early Treatment for Retinopathy of Prematurity Cooperative Group; Good WV, Hardy RJ, Dobson V, Palmer EA, Phelps DL, Tung B, Redford M. Final visual acuity results in the early treatment for retinopathy of prematurity study. Arch Ophthalmol. 2010 Jun;128(6):663-71. doi: 10.1001/archophthalmol.2010.72. Epub 2010 Apr 12.
Other Identifiers
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NEI-83
Identifier Type: -
Identifier Source: org_study_id