Retinopathy of Prematurity
Conditions
Keywords
Retinopathy of Prematurity
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.
Interventions
None listed
Sponsors
Pediatrix
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of visual acuity in subjects who were treated for ROP | Five year follow-up |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed