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Trial record 36 of 293 for:    retinopathy of prematurity

Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279669
Recruitment Status : Suspended (Studies are suspended until a new ultrasound scanner is acquired.)
First Posted : January 19, 2006
Last Update Posted : May 8, 2008
Columbia University
Information provided by:
Weill Medical College of Cornell University

Brief Summary:
Premature infants stand a risk of danger to the layer of the eye that creates sight that, if untreated, can cause severe vision problems, leading to blindness in some cases. This research study will use ultrasound to examine the eye for retinal changes of prematurity.

Condition or disease Intervention/treatment
Retinopathy of Prematurity Procedure: Ultrasound examination

Detailed Description:

Retinopathy of prematurity requires the early detection of retinopathy in neonates with a gestational age of < 28 weeks and a birth weight <1500 g. These evaluations require pupillary dilation, diagnostic expertise, consume much time and expense and are not without morbidity.

B-scan ultrasonography using a hand-held probe is part of the current ophthalmologist's armamentarium, providing a non-invasive view of the eye and avoiding the morbidity associated with mydriatic drops used for pupillary dilation.

We will use a simple water bath enclosure for a standard 20 MHz probe currently in general ophthalmic use to determine whether this simple technique might supplant indirect ophthalmoscopy as a screening technique. We will compare, using masked observers, the clinical findings of indirect ophthalmoscopy of neonatal infants with ultrasonic findings to determine if a correlation in the stages of retinopathy of prematurity (ROP) between the two techniques existed.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity
Study Start Date : December 2004
Estimated Study Completion Date : July 2008

Intervention Details:
  • Procedure: Ultrasound examination
    contact ultrasound examination
    Other Name: Quantel Cinescan

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature babies with Retinopathy of Prematurity

Inclusion Criteria:

premature birth

Exclusion Criteria:

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 identifier (NCT number): NCT00279669

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United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Weill Medical College of Cornell University
Columbia University
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Principal Investigator: Dan H Kauffmann-Jokl, MD Columbia University
Principal Investigator: Ronald H Silverman, PhD Weill Medical College of Cornell University

Publications of Results:
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Responsible Party: Dan H. Kauffmann-Jokl, MD, Columbia Presbyterian Medical Center Identifier: NCT00279669     History of Changes
Other Study ID Numbers: ROP
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: May 8, 2008
Last Verified: May 2008

Keywords provided by Weill Medical College of Cornell University:
Retinopathy of Prematurity

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