Registry for Severe ROP and Treatment on Visual Outcomes
Completed
- Conditions
- Retinopathy of Prematurity
- Registration Number
- NCT01559571
- Lead Sponsor
- Pediatrix
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of visual acuity in subjects who were treated for ROP Five year follow-up
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Summerlin Hospital Medical Center
🇺🇸Las Vegas, Nevada, United States