Registry for Severe ROP and Treatment on Visual Outcomes

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Hospital of South Bend, South Bend, Indiana, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Registry information

Official study title

Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2020
First posted: Mar 21, 2012
Registry last updated: Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed