Registry for Severe ROP and Treatment on Visual Outcomes

Pediatrix324 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

324

Conditions

Retinopathy of Prematurity

Eligibility

Sex: ALLMax age: 7 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Memorial Hospital of South Bend

South Bend, Indiana, United States

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Identification of visual acuity in subjects who were treated for ROP

Time frame: Five year follow-up

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.