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Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT00000133
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : February 4, 2014
Sponsor:
Information provided by:
National Eye Institute (NEI)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Procedure: Trans-scleral Cryotherapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Study Start Date : January 1986
Actual Study Completion Date : August 2003

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000133


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Locations
United States, Alabama
Alabama Ophthalmology Associates, P.C.
Birmingham, Alabama, United States
United States, District of Columbia
Private practice of David Plotsky, MD
Washington, District of Columbia, United States
Retina Group of Washington
Washington, District of Columbia, United States
United States, Florida
Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida, United States
United States, Illinois
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, United States
United States, Indiana
Department of Ophthalmology, Indiana University School of Medicine
Indianapolis, Indiana, United States
United States, Kentucky
Kentucky Lions Eye Research Institute, University of Louisville
Louisville, Kentucky, United States
United States, Louisiana
Department of Ophthalmology, Tulane University School of Medicine
New Orleans, Louisiana, United States
United States, Maryland
Wilmer Eye Institute, The Johns Hopkins Medical Institutions
Baltimore, Maryland, United States
United States, Michigan
Private practice of John D. Baker, MD
Dearborn, Michigan, United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States
United States, Minnesota
Department of Ophthalmology, University of Minnesota
Minneapolis, Minnesota, United States
United States, New York
Strong Children's Hospital, University of Rochester Medical Center
Rochester, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Ohio
Private Practice of Miles J. Burke, MD
Cincinnati, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
United States, Oregon
Oregon Health & Science University, Casey Eye Institute
Portland, Oregon, United States
United States, Pennsylvania
Children's Hospital of Philadelphia, Division of Pediatric Ophthalmology
Philadelphia, Pennsylvania, United States
Pediatric Ophthalmology and Strabismus, Inc.
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Department of Ophthalmology, Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Texas
Private practice of Rand Spencer, M.D.
Dallas, Texas, United States
University of Texas Health Science Center, San Antonio, Department of Ophthalmology
San Antonio, Texas, United States
United States, Utah
John Moran Eye Center
Salt Lake City, Utah, United States
Sponsors and Collaborators
National Eye Institute (NEI)

Additional Information:
Publications:
Trueb L; Evans J; Hammel A; Bartholomew P; Dobson D; Assessing visual acuity of visually impaired children using the Teller acuity cards., Am Orthoptic J 1992;42:149-154
Evans MS; Wallace PR; Palmer EA; Fundus photography in small infants., J Ophthal Photography 1993;15(1):38-39
Bartholomew PA; Chao J; Evans JL; Hammel AM; Trueb AL; Verness JL; Dobson V; Quinn GE; Acceptance/Use of the Teller acuity card procedure in the clinic., Am Orthoptic J 1996;46:100-106

ClinicalTrials.gov Identifier: NCT00000133     History of Changes
Other Study ID Numbers: NEI-32
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: October 2003

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases