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A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT01335113
Recruitment Status : Unknown
Verified April 2011 by Stanford University.
Recruitment status was:  Recruiting
First Posted : April 14, 2011
Last Update Posted : April 14, 2011
Sponsor:
Collaborator:
University of Miami
Information provided by:
Stanford University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity.

Condition or disease
Retinopathy of Prematurity

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
Study Start Date : October 2010
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. axial length [ Time Frame: one year ]
    axial length as measured by a scan ulstrasonography


Secondary Outcome Measures :
  1. anterior corneal curvature [ Time Frame: one year ]
    anterior corneal curvature as measured by keratometer

  2. wide angle fundus photography [ Time Frame: one year ]
    wide angle fundus photography by RetCam camera


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature newborns who are screened for retinopathy of prematurity at Stanford
Criteria

Inclusion Criteria:

  • neonates being screened for retinopathy of prematurity

Exclusion Criteria:

  • medically unstable neonates
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335113


Contacts
Contact: Darius M Mosfeghi, MD 650-723-6995 dariusm@stanford.edu
Contact: Annie Chan, MD 650-723-6995 anchan@stanford.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Andrew A Moshfeghi, MD    561-515-1500    amoshfeghi@med.miami.edu   
Contact: Audina M Berrocal, MD    305-326-6000 ext 5100    aberrocal@med.miami.edu   
Principal Investigator: Andrew A Moshfeghi, MD         
Sub-Investigator: Audina M Berrocal, MD         
Sponsors and Collaborators
Stanford University
University of Miami
Investigators
Study Director: Darius M Moshfeghi, MD Stanford University
Principal Investigator: Darius Moshfeghi, MD Stanford University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Darius M. Moshfeghi, MD, Stanford University
ClinicalTrials.gov Identifier: NCT01335113     History of Changes
Other Study ID Numbers: 19891
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases