Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment|
|Retinopathy of Prematurity||Procedure: Ultrasound examination|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity|
|Study Start Date :||December 2004|
|Estimated Study Completion Date :||July 2008|
Procedure: Ultrasound examination
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): NCT00279669
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Dan H Kauffmann-Jokl, MD||Columbia University|
|Principal Investigator:||Ronald H Silverman, PhD||Weill Medical College of Cornell University|