Registry for Severe ROP and Treatment on Visual Outcomes

Pediatrix

Status: Completed

Conditions: Retinopathy of Prematurity

Study type: Observational

Funder types: Other

Identifiers

NCT01559571

PDX-01-011

Details and patient eligibility

About

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.

Enrollment: 324 patients

Sex: All

Ages: Under 7 days old

Volunteers: Accepts Healthy Volunteers

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