Registry for Severe ROP and Treatment on Visual Outcomes
Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates
1 other identifier
observational
324
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2012
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedJune 30, 2020
June 1, 2020
8 years
February 28, 2012
June 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of visual acuity in subjects who were treated for ROP
Five year follow-up
Secondary Outcomes (1)
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
Five year follow-up
Eligibility Criteria
Neonates who have a diagnosis of Retinopathy of Prematurity Stage 2 or higher
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pediatrixlead
Study Sites (2)
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Related Publications (1)
Tolia VN, Ahmad KA, Jacob J, Kelleher AS, McLane N, Arnold RW, Clark RH; MEDNAX ROP Registry Investigators. Two-Year Outcomes of Infants with Stage 2 or Higher Retinopathy of Prematurity: Results from a Large Multicenter Registry. Am J Perinatol. 2020 Jan;37(2):196-203. doi: 10.1055/s-0039-1694983. Epub 2019 Sep 3.
PMID: 31480086DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reese H Clark, MD
Pediatrix
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
March 21, 2012
Study Start
May 1, 2012
Primary Completion
May 15, 2020
Study Completion
May 15, 2020
Last Updated
June 30, 2020
Record last verified: 2020-06