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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00000133 |
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 | Intervention |
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Retinopathy of Prematurity |
Procedure: Trans-scleral Cryotherapy |
Study Type: | Interventional |
Study Design: | Randomized, Safety/Efficacy Study |
Ages Eligible for Study: | up to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Study ID Numbers: | NEI-32 |
Study First Received: | September 23, 1999 |
Last Updated: | June 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00000133 |
Health Authority: | United States: Federal Government |
Eye Diseases Retinopathy of prematurity Infant, Newborn, Diseases |
Infant, Premature, Diseases Retinopathy of Prematurity Retinal Diseases |