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
  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:


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:
    Procedure: Ultrasound examination
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 24, 2014