Annular Array Ultrasound in Ophthalmology
High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging
2 other identifiers
observational
30
1 country
1
Brief Summary
The objective of this research is to improve the care of ocular disease and disorders, in particular the changes in the eye associated with diabetes, by providing clinicians with dramatically improved ultrasonic images of the entire eye. The research combines advanced high-frequency, high-resolution ultrasonic annular arrays transducers with new processing techniques designed to overcome several limits that have been reached with conventional high frequency ultrasound systems. The investigators propose that diagnosis of eye diseases using annular arrays can be more effective than the conventional ultrasound images by at least 50%; i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected with the annular arrays.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 30, 2019
January 1, 2019
5.2 years
July 25, 2011
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in detection of posterior vitreous detachment: 20MHz annular array versus 10MHz single element
The investigators will examine eyes with both conventional 10MHz ultrasound and a 20MHz annular array with synthetic focusing. The investigators will evaluate and compare images acquired with both techniques and determine their relative efficacy in visualizing the presence or absence of posterior vitreous detachment.
Subjects will be examined with both the 20MHz annular array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration.
Study Arms (1)
Annular Array Ultrasound
Subject with possible or with known posterior vitreous detachment. Subjects with diabetic retinopathy will receive annular array ultrasound exam.
Interventions
For this research study you will be asked to sit in a chair. You will be given 2 drops of a numbing solution. The ultrasound camera will be enclosed in a sterile membrane and will be placed gently upon your eye. You may be asked to gaze at a light source while measurements are being made. The procedure will last about 10-15 minutes from start to finish.
Eligibility Criteria
University-based Ophthalmology Practice
You may qualify if:
- over age 60
- people with diabetic retinopathy or posterior vitreous detachments
You may not qualify if:
- under age 60
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Riverside Research Institutecollaborator
- National Eye Institute (NEI)collaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (7)
Mamou J, Aristizabal O, Silverman RH, Ketterling JA, Turnbull DH. High-frequency chirp ultrasound imaging with an annular array for ophthalmologic and small-animal imaging. Ultrasound Med Biol. 2009 Jul;35(7):1198-208. doi: 10.1016/j.ultrasmedbio.2008.12.017. Epub 2009 Apr 25.
PMID: 19394754BACKGROUNDMamou J, Ketterling JA, Silverman RH. Chirp-coded excitation imaging with a high-frequency ultrasound annular array. IEEE Trans Ultrason Ferroelectr Freq Control. 2008 Feb;55(2):508-13. doi: 10.1109/TUFFC.2008.670.
PMID: 18334358BACKGROUNDSilverman RH, Ketterling JA, Coleman DJ. High-frequency ultrasonic imaging of the anterior segment using an annular array transducer. Ophthalmology. 2007 Apr;114(4):816-22. doi: 10.1016/j.ophtha.2006.07.050. Epub 2006 Nov 30.
PMID: 17141314BACKGROUNDFiloux E, Sampathkumar A, Chitnis PV, Aristizabal O, Ketterling JA. High-frequency annular array with coaxial illumination for dual-modality ultrasonic and photoacoustic imaging. Rev Sci Instrum. 2013 May;84(5):053705. doi: 10.1063/1.4804636.
PMID: 23742556BACKGROUNDLethiecq M, Lou-Moeller R, Ketterling J, Levassort F, Tran-Huu-Hue LP, Filoux E, Silverman RH, Wolny WW. Non-planar pad-printed thick-film focused high-frequency ultrasonic transducers for imaging and therapeutic applications. IEEE Trans Ultrason Ferroelectr Freq Control. 2012 Sep;59(9):1976-82. doi: 10.1109/TUFFC.2012.2416.
PMID: 23007770BACKGROUNDMamou J, Wa CA, Yee KM, Silverman RH, Ketterling JA, Sadun AA, Sebag J. Ultrasound-based quantification of vitreous floaters correlates with contrast sensitivity and quality of life. Invest Ophthalmol Vis Sci. 2015 Jan 22;56(3):1611-7. doi: 10.1167/iovs.14-15414.
PMID: 25613948RESULTSilverman RH, Ketterling JA, Mamou J, Lloyd HO, Filoux E, Coleman DJ. Pulse-encoded ultrasound imaging of the vitreous with an annular array. Ophthalmic Surg Lasers Imaging. 2012 Jan-Feb;43(1):82-6. doi: 10.3928/15428877-20110901-03. Epub 2011 Sep 8.
PMID: 21902166RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald H Silverman, PhD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthamlic Science
Study Record Dates
First Submitted
July 25, 2011
First Posted
August 11, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 30, 2019
Record last verified: 2019-01