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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2003 by National Eye Institute (NEI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000133
First received: September 23, 1999
Last updated: June 2, 2006
Last verified: October 2003
History of Changes
  Purpose

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
Retinopathy of Prematurity
 Procedure: Trans-scleral Cryotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Eye Institute (NEI):

Study Start Date: January 1986
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000133

  Show 24 Study Locations
Sponsors and Collaborators
National Eye Institute (NEI)
  More Information

Additional Information:
Clinical Alert to Pediatric Ophthalmologists, Retinal Specialists, Neonatologists, and Directors of Neonatal Intensive Care Units  This link exits the ClinicalTrials.gov site
NEI Press Release-Freeze Treatment Reduces Blindness in Premature Infants  This link exits the ClinicalTrials.gov site
NIH Press Release-Study Confirms Value Of Treatment To Prevent Blindness In Premature Babies  This link exits the ClinicalTrials.gov site

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
Study First Received: September 23, 1999
Last Updated: June 2, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 21, 2013