Overview

This trial is active, not recruiting.

Condition retinopathy of prematurity
Sponsor Mednax Center for Research, Education and Quality
Start date May 2012
End date December 2019
Trial size 324 participants
Trial identifier NCT01559571, PDX-01-011

Summary

The purpose of this study is to determine what factors influence the visual outcomes of infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Identification of visual acuity in subjects who were treated for ROP
time frame: Five year follow-up

Secondary Outcomes

Measure
Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II
time frame: Five year follow-up

Eligibility Criteria

Male or female participants up to 7 days old.

Inclusion Criteria: - Documentation of informed consent and authorization - Inborn and those admitted within 7 days of birth - Infant with a diagnosis of stage 2 ROP or higher - Site ability to plan close ophthalmological follow-up due to significant and persistent ROP - Parents must agree to report outcomes following each ophthalmological visit and overall outcomes for up to five (5) years of age - Ability to obtain follow-up data on outcomes if the child is transferred to another facility - No known major congenital anomalies Exclusion Criteria: - ROP stage 1 or less - Parents unwilling to participate in follow-up - Major congenital anomalies

Additional Information

Official title Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates
Principal investigator Reese H Clark, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mednax Center for Research, Education and Quality.