Status:
COMPLETED
Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
Up to 1 years
Phase:
NA
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. T...
Detailed Description
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 establish...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 1986
Trial Type :
INTERVENTIONAL
End Date :
August 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000133
Start Date
January 1 1986
End Date
August 1 2003
Last Update
February 4 2014
Active Locations (24)
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1
Alabama Ophthalmology Associates, P.C.
Birmingham, Alabama, United States
2
Private practice of David Plotsky, MD
Washington D.C., District of Columbia, United States
3
Retina Group of Washington
Washington D.C., District of Columbia, United States
4
Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida, United States