Registry for Severe ROP and Treatment on Visual Outcomes

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

Sponsors

Lead Sponsor: Mednax Center for Research, Education, Quality and Safety

Source Mednax Center for Research, Education, Quality and Safety
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.

Overall Status Completed
Start Date May 2012
Completion Date May 15, 2020
Primary Completion Date May 15, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Identification of visual acuity in subjects who were treated for ROP Five year follow-up
Secondary Outcome
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
Enrollment 324
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 7 Days

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Reese H Clark, MD Principal Investigator Mednax Center for Research, Education, Quality and Safety
Location
Facility:
Memorial Hospital of South Bend | South Bend, Indiana, 46601, United States
Summerlin Hospital Medical Center | Las Vegas, Nevada, 89144, United States
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov