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A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Miami
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01335113
First received: April 1, 2011
Last updated: April 12, 2011
Last verified: April 2011
History of Changes
  Purpose
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
Retinopathy of Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • axial length [ Time Frame: one year ] [ Designated as safety issue: No ]
    axial length as measured by a scan ulstrasonography


Secondary Outcome Measures:
  • anterior corneal curvature [ Time Frame: one year ] [ Designated as safety issue: No ]
    anterior corneal curvature as measured by keratometer

  • wide angle fundus photography [ Time Frame: one year ] [ Designated as safety issue: No ]
    wide angle fundus photography by RetCam camera
Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Darius M. Moshfeghi, MD, Stanford University
ClinicalTrials.gov Identifier: NCT01335113     History of Changes
Other Study ID Numbers: 19891 
Study First Received: April 1, 2011
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016