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The Early Treatment for Retinopathy of Prematurity Study (ETROP) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about The Early Treatment for Retinopathy of Prematurity Study (ETROP) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The Early Treatment for Retinopathy of Prematurity Study (ETROP) Clinical research trials and The Early Treatment for Retinopathy of Prematurity Study (ETROP) health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Early Treatment for Retinopathy of Prematurity Study (ETROP). The Early Treatment for Retinopathy of Prematurity Study (ETROP) Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a The Early Treatment for Retinopathy of Prematurity Study (ETROP) clinical trial. Human subjects often get the best healthcare possible for their The Early Treatment for Retinopathy of Prematurity Study (ETROP) condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Early Treatment for Retinopathy of Prematurity Study (ETROP)  The Early Treatment for Retinopathy of Prematurity Study (ETROP)
The Early Treatment for Retinopathy of Prematurity Study (ETROP)
For Condition: Retinopathy of Prematurity
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: /42 Days
Genders: Both
Protocol Entry Criteria: Infants <1251 grams birthweight born at participating centers and/or examined by 42 days of life are eligible. The early treatment trial requires that an infant have prethreshold retinopathy of prematurity (ROP).
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamGood, Study Chair, Smith-Kettlewell Eye Research Institute
Columbus Children's Hospital
Columbus, Ohio, 43205
United States
John Moran Eye Center University of Utah Health Sciences Center
Salt Lake City, Utah,
United States
Tulane University Medical Center
New Orleans, Louisiana, 70112-2699
United States
The Children's Hospital of Buffalo Department of Ophthalmology
Buffalo, New York, 14222-2099
United States
University of Louisville Health Sciences Center
Louisville, Kentucky, 40202-1594
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
Stanford University School of Medicine
Palo Alto, California, 94304
United States
Cardinal Glennon Children's Hospital Neonatology Office
St. Louis, Missouri, 63104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-2236
United States
Duke University Eye Center
Durham, North Carolina, 27710
United States
The Zanvyl Krieger Children's Eye Center
Baltimore, Maryland, 21287
United States
UIC Eye Center Department of Ophthalmology and Visual Sciences The Lions of Illinois Eye Research Institute
Chicago, Illinois, 60612-724
United States
Baylor College of Medicine Feigin Center
Houston, Texas, 77030
United States
Pediatric Ophthalmology Associates, PC
Dearborn, Michigan, 48124
United States
Indiana University Department of Pediatrics
Indianapolis, Indiana, 46002-2119
United States
Tufts University School of Medicine Department of Pediatrics
Boston, Massachusetts, 02111
United States
Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213-3180
United States
The Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1595
United States
University of Minnesota
Minneapolis, Minnesota, 55455-0591
United States
Edward S. Harkness Eye Institute
New York City, New York, 10032
United States
Oregon Health Sciences University Casey Eye Institute
Portland, Oregon, 97201-4197
United States
Smith-Kettlewell Eye Research Institute
San Francisco, California, 94115-1813
United States
Eastern Long Island Retina Associate
Shirley, New York, 111967
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
The Children's Hospital of Philadelphia Division of Pediatric Ophthalmology
Philadelphia, Pennsylvania, 19104-4399
United States
Additional Information:
Study ID Numbers: NEI-83;
Study Start Date: October 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027222
Other Retinopathy Of Prematurity Studies:
1. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
2. The Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)
3. Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)
4. The Early Treatment for Retinopathy of Prematurity Study (ETROP)
Related Studies:
Other Retinopathy of Prematurity Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
The Early Treatment for Retinopathy of Prematurity Study (ETROP)
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