The Early Treatment for Retinopathy of Prematurity Study (ETROP)
- Conditions
- Retinopathy of Prematurity
- Registration Number
- NCT00027222
- Lead Sponsor
- National Eye Institute (NEI)
- Brief Summary
The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.
- Detailed Description
At age 5 1/2 years, the oldest age for which follow-up data are available, children with threshold ROP who were enrolled in the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) -- Outcome Study showed fewer treated eyes (31.5 percent) than control eyes (48 percent) that were blind (P\<0.001). Of those eyes that had a favorable structural outcome, with or without retinal ablation (cryotherapy to destroy the fringe of the retina through freezing), only a small percentage had best corrected visual acuity better than or equal to 20/40 at age 5 1/2 years (13 percent in the treated group; 17 percent in the untreated control group (P=0.19)). Among the 1398 followed from the 5 large natural history centers of the CRYO-ROP follow-up study, children with retinal residua of ROP (structural changes) had measurable visual acuity that was severly affected and tended to worsen with age. The CRYO-ROP Study proved conclusively that peripheral retinal ablation improves the chances of avoiding blindness, but at least 80 percent of eyes are left with acuity less than 20/40.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Magee-Women's Hospital
๐บ๐ธPittsburgh, Pennsylvania, United States
University of Maryland School of Medicine
๐บ๐ธBaltimore, Maryland, United States
The Zanvyl Krieger Children's Eye Center
๐บ๐ธBaltimore, Maryland, United States
Cardinal Glennon Children's Hospital Neonatology Office
๐บ๐ธSt. Louis, Missouri, United States
Stanford University School of Medicine
๐บ๐ธPalo Alto, California, United States
Indiana University Department of Pediatrics
๐บ๐ธIndianapolis, Indiana, United States
Columbus Children's Hospital
๐บ๐ธColumbus, Ohio, United States
John Moran Eye Center University of Utah Health Sciences Center
๐บ๐ธSalt Lake City, Utah, United States
University of Texas Health Science Center at San Antonio
๐บ๐ธSan Antonio, Texas, United States
Smith-Kettlewell Eye Research Institute
๐บ๐ธSan Francisco, California, United States
UIC Eye Center Department of Ophthalmology and Visual Sciences The Lions of Illinois Eye Research Institute
๐บ๐ธChicago, Illinois, United States
University of Louisville Health Sciences Center
๐บ๐ธLouisville, Kentucky, United States
Pediatric Ophthalmology Associates, PC
๐บ๐ธDearborn, Michigan, United States
Tufts University School of Medicine Department of Pediatrics
๐บ๐ธBoston, Massachusetts, United States
University of Minnesota
๐บ๐ธMinneapolis, Minnesota, United States
Duke University Eye Center
๐บ๐ธDurham, North Carolina, United States
Edward S. Harkness Eye Institute
๐บ๐ธNew York, New York, United States
The Children's Hospital of Buffalo Department of Ophthalmology
๐บ๐ธBuffalo, New York, United States
The Dean A. McGee Eye Institute
๐บ๐ธOklahoma City, Oklahoma, United States
Eastern Long Island Retina Associate
๐บ๐ธShirley, New York, United States
The Children's Hospital of Philadelphia Division of Pediatric Ophthalmology
๐บ๐ธPhiladelphia, Pennsylvania, United States
Oregon Health Sciences University Casey Eye Institute
๐บ๐ธPortland, Oregon, United States
Baylor College of Medicine Feigin Center
๐บ๐ธHouston, Texas, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
Tulane University Medical Center
๐บ๐ธNew Orleans, Louisiana, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States