Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

This study has suspended participant recruitment.

(Studies are suspended until a new ultrasound scanner is acquired.)

Sponsor:

Collaborator:

Columbia University

Information provided by:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00279669

First received: January 17, 2006

Last updated: May 7, 2008

Last verified: May 2008

History of Changes

Purpose

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	Intervention
Retinopathy of Prematurity	Procedure: Ultrasound examination

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies Retinal Disorders

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Estimated Enrollment:	30
Study Start Date:	December 2004
Estimated Study Completion Date:	July 2008

Intervention Details:

contact ultrasound examination

Other Name: Quantel Cinescan

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Premature babies with Retinopathy of Prematurity

Criteria

Inclusion Criteria:

premature birth

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279669

Locations

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

Investigators

Principal Investigator:	Dan H Kauffmann-Jokl, MD	Columbia University
Principal Investigator:	Ronald H Silverman, PhD	Weill Medical College of Cornell University

More Information

Publications:

Jokl DH, Silverman RH, Springer AD, Towers H, Kane S, Lopez R, Chiang MF, Lloyd HO, Barbazetto I, Horowitz R, Vidne O. Comparison of ultrasonic and ophthalmoscopic evaluation of retinopathy of prematurity. J Pediatr Ophthalmol Strabismus. 2004 Nov-Dec;41(6):345-50.

Jokl DH, Silverman RH, Nemerofiky SL, Kane SA, Chiang MF, Lopez R, Lee G. Is there a role for high-frequency ultrasonography in clinical staging of retinopathy of prematurity? J Pediatr Ophthalmol Strabismus. 2006 Jan-Feb;43(1):31-5. Erratum in: J Pediatr Ophthalmol Strabismus. 2006 Mar-Apr;43(2):84.

D. H. Kauffmann Jokl, R. H. Silverman, IV, S. Kane, R. Lopez, M. F. Chiang, and S. L. Nemerofsky. Cribside Ultrasonography for the Early Detection of Rapidly Progressive Zone 1 ROP Retinal Detachment: Implications for Early Surgical Intervention. Invest. Ophthalmol. Vis. Sci. 2007 48: E-Abstract 3094.

Responsible Party:	Dan H. Kauffmann-Jokl, MD, Columbia Presbyterian Medical Center
ClinicalTrials.gov Identifier:	NCT00279669 History of Changes
Other Study ID Numbers:	ROP
Study First Received:	January 17, 2006
Last Updated:	May 7, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:

Retinopathy of Prematurity
Ultrasound
Eye

Additional relevant MeSH terms:

Retinal Detachment
Retinal Diseases
Retinopathy of Prematurity

Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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