Clinical Trial: Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

Official Title: Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

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.

Detailed Summary:

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.

Sponsor: Weill Medical College of Cornell University

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Information By: Weill Medical College of Cornell University

Dates:
Date Received: January 17, 2006
Date Started: December 2004
Date Completion: July 2008
Last Updated: May 7, 2008
Last Verified: May 2008