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Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity Clinical research trials and Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity clinical trial. Subjects frequently obtain the most expert healthcare possible for their Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity  Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
For Condition: Retinopathy of Prematurity
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness from ROP. To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and without cryotherapy.
Details: ROP is a disease of the eyes of prematurely born infants in which the retinal blood vessels increase in number and branch excessively, sometimes leading to hemorrhage or scarring. Before the establishment of this study in 1985, more than 500 infants annually were blinded by ROP in the United States alone. More than 30 years ago, the National Institutes of Health sponsored a clinical trial that showed that if premature babies are given oxygen only as needed, the number of infants who develop ROP drops dramatically. Subsequently, hospitals cut back on giving excessive oxygen routinely to premature babies. But, with improvements in neonatal care over the last two decades, the number of babies at risk is increasing as survival rates for smaller premature infants improve. The lower the birth weight, the higher the incidence and severity of ROP. In a more recent NEI-supported study at the University of Miami, blood oxygen levels of very low birth-weight infants were monitored continuously by use of transcutaneous measurements as long as oxygen therapy was needed. The study showed that there is no statistically significant difference between the rates of ROP in infants monitored on continuous oxygen therapy and in those monitored only when they were receiving oxygen in excess of 40 percent. The Supplemental Therapeutic Oxygen for Prethreshold ROP (STOP-ROP) trial, also funded by the NEI, studied whether a slight increase in oxygen therapy would prevent the progression of moderate ROP to ROP severe enough to require surgical treatment. This intervention made little or no difference in outcomes. Likewise, another NEI-sponsored clinical trial (LIGHT-ROP) demonstrated absence of protective effect on ROP by limiting light exposure to newborn premature infants. These studies have led to the conclusion that factors other than oxygen or light exposure must be involved in causing ROP. In most infants who develop ROP, the disease spontaneously subsides, permitting development of normal vision. But other infants who progress to a severe form of ROP are in danger of becoming permanently blind. Although the cause of ROP is not fully explained, scientists are seeking ways to treat ROP successfully and to find the right time in the progression of the disease to use treatment. Cryotherapy, which destroys the fringe of the retina through freezing, is the only treatment so far that has been demonstrated to provide substantial benefit to these eyes. The multicenter trial of cryotherapy for ROP enrolled more than 4,000 premature infants who weighed no more than 1,250 grams at birth. This category of infants is at the greatest risk of developing ROP. The eyes of the infants enrolled in the study were examined at predetermined intervals while the subjects were still in the intensive care nursery. After the pupils were dilated with eye drops, the eyes were examined by an ophthalmologist using a binocular indirect ophthalmoscope to visualize the developing retina. The natural history of the condition of each infant's retina was recorded. When examination disclosed the severe form of ROP (threshold ROP) in both eyes, and the parents gave informed consent, one of the infant's eyes was randomly selected to receive cryotherapy. In this technique, a cryoprobe was used to freeze and thus destroy the peripheral extent of the retina, thereby arresting the development of the blood vessels growing wildly toward it. Outcome of the therapy was assessed at 3 months and 12 months following randomization by an extensive examination that included photography of the interior of both the treated and the control eyes. The 12-month exam also measured visual function with preferential-looking techniques. Such measurements allowed correlations between fundus photographs and visual function and a comparison of visual function for treated versus control eyes. Neither the trained photograph readers who evaluated the pictures from both eyes nor the specially trained vision testers knew which eyes had received cryotherapy. Additional assessments of visual acuity and retinal status have been made approximately each year up to the present. Currently (2001), preparations are being made for a 15-year outcome study that will conclude by 2003.
Eligibility:
Study Type: Interventional, Randomized, Safety/Efficacy Study
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: Premature infants of either gender who were eligible for the natural history study had weighed less than 1,251 grams at birth and had survived the first 28 days of life. They had no major ocular or systemic congenital anomalies. Infants who met these criteria and also had a threshold level of ROP (defined as stage 3+ of the International Classification of Retinopathy of Prematurity occupying five or more contiguous or eight cumulative 30 degree sectors [clock hours] of stage 3 ROP in zone I or II in the presence of plus disease) could be referred for examination to determine eligibility for entry to the cryotherapy trial.
Total Enrollment:
Location and Contact Information:
Alabama Ophthalmology Associates, P.C.
Birmingham, Alabama,
United States
Department of Ophthalmology, Tulane University School of Medicine
New Orleans, Louisiana,
United States
Department of Ophthalmology, University of Minnesota
Minneapolis, Minnesota,
United States
Columbus Children's Hospital
Columbus, Ohio,
United States
Private practice of David Plotsky, MD
Washington D.C., District of Columbia,
United States
Department of Ophthalmology, Indiana University School of Medicine
Indianapolis, Indiana,
United States
Duke University Medical Center
Durham, North Carolina,
United States
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina,
United States
University of Illinois Eye and Ear Infirmary
Chicago, Illinois,
United States
John Moran Eye Center
Salt Lake City, Utah,
United States
Strong Children's Hospital, University of Rochester Medical Center
Rochester, New York,
United States
Children's Hospital of Philadelphia, Division of Pediatric Ophthalmology
Philadelphia, Pennsylvania,
United States
Pediatric Ophthalmology and Strabismus, Inc.
Pittsburgh, Pennsylvania,
United States
Department of Ophthalmology, Vanderbilt University Medical Center
Nashville, Tennessee,
United States
Oregon Health & Science University, Casey Eye Institute
Portland, Oregon,
United States
Private Practice of Miles J. Burke, MD
Cincinnati, Ohio,
United States
Retina Group of Washington
Washington D.C., District of Columbia,
United States
Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida,
United States
Private practice of Rand Spencer, M.D.
Dallas, Texas,
United States
Kentucky Lions Eye Research Institute, University of Louisville
Louisville, Kentucky,
United States
Wilmer Eye Institute, The Johns Hopkins Medical Institutions
Baltimore, Maryland,
United States
Private practice of John D. Baker, MD
Dearborn, Michigan,
United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan,
United States
University of Texas Health Science Center, San Antonio, Department of Ophthalmology
San Antonio, Texas,
United States
Additional Information:
Study ID Numbers: NEI-32;
Study Start Date: January 1986
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000133
Other Retinopathy Of Prematurity Studies:
1. Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)
2. The Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)
3. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
4. The Early Treatment for Retinopathy of Prematurity Study (ETROP)
Related Studies:
Other Retinopathy of Prematurity Clinical Trials
Other Michigan Clinical Trials
Other Royal Oak Clinical Trials
Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
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