Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

Official title:

Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279669
• Other study ID #: ROP
• Status: Completed
• Start date: December 2004
• Est. completion date: April 30, 2010

Study information

• Verified date: March 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2010
• Est. primary completion date: April 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

premature birth

Exclusion Criteria:

Related Conditions & MeSH terms

• Premature Birth
• Retinal Detachment
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Procedure:
• Ultrasound examination
contact ultrasound examination

Locations

Country	Name	City	State
United States	Columbia Presbyterian Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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 — View Citation

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( — View Citation