Registry for Severe ROP and Treatment on Visual Outcomes

Retinopathy of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559571
• Other study ID #: PDX-01-011
• Status: Completed
• Start date: May 2012
• Est. completion date: May 15, 2020

Study information

• Verified date: June 2020
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Locations

Country	Name	City	State
United States	Summerlin Hospital Medical Center	Las Vegas	Nevada
United States	Memorial Hospital of South Bend	South Bend	Indiana

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of visual acuity in subjects who were treated for ROP		Five year follow-up
Secondary	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