Registry for Severe ROP and Treatment on Visual Outcomes

Completed

Conditions studied: Retinopathy of Prematurity

In brief

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.

Key facts

Study ID

NCT01559571

Run by

Pediatrix

People needed

324

Starts

2012-05-01

Expected to finish

2020-05-15

Last updated by the study team

2020-06-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• ROP stage 1 or less
• Parents unwilling to participate in follow-up
• Major congenital anomalies

Where it is running

• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Summerlin Hospital Medical Center — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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