Registry for Severe ROP and Treatment on Visual Outcomes

June 29, 2020 updated by: Mednax Center for Research, Education, Quality and Safety

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Summerlin Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates who have a diagnosis of Retinopathy of Prematurity Stage 2 or higher

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of visual acuity in subjects who were treated for ROP
Time Frame: Five year follow-up
Five year follow-up

Secondary Outcome Measures

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
Time Frame: Five year follow-up
Five year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mednax Center for Research, Education, Quality and Safety

Investigators

  • Principal Investigator: Reese H Clark, MD, Mednax Center for Research, Education, Quality and Safety

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDX-01-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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