NCT00279669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2010

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

5.4 years

First QC Date

January 17, 2006

Last Update Submit

March 27, 2019

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of PrematurityUltrasoundEye

Interventions

Ultrasound examinationPROCEDURE

contact ultrasound examination

Also known as: Quantel Cinescan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Premature babies with Retinopathy of Prematurity

You may qualify if:

  • premature birth

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

  • 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. doi: 10.3928/01913913-20041101-06.

    PMID: 15609519RESULT

  • 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. doi: 10.3928/01913913-20060101-04.

    PMID: 16491723RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Dan H Kauffmann-Jokl, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Ronald H Silverman, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

December 1, 2004

Primary Completion

April 30, 2010

Study Completion

April 30, 2010

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

US(1)