Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia Presbyterian Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

premature birth

Exclusion criteria

none

Treatment and study plan

ultrasound examination

Procedure

contact ultrasound examination

Other names: Quantel Cinescan

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Columbia University

Registry information

Important dates

Study start: 2004
Primary completion: 2010
Study completion: 2010
First posted: Jan 19, 2006
Registry last updated: Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed