A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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:

MedlinePlus related topics: Retinal Disorders Ultrasound

Genetic and Rare Diseases Information Center resources: Retinopathy of Prematurity

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

axial length [ Time Frame: one year ]
axial length as measured by a scan ulstrasonography

Secondary Outcome Measures:

anterior corneal curvature [ Time Frame: one year ]
anterior corneal curvature as measured by keratometer
wide angle fundus photography [ Time Frame: one year ]
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
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

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

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 July 24, 2017

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