NCT01415037

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

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 Oct 2011

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

First Submitted

Initial submission to the registry

July 25, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

5.2 years

First QC Date

July 25, 2011

Last Update Submit

January 29, 2019

Conditions

Keywords

Annular Array UltrasoundUltrasound ExamPosterior Vitreous DetachmentPVDDiabetic Retinopathy

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.

Procedure: 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.

Annular Array Ultrasound

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

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: 19394754BACKGROUND
  • Mamou 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: 18334358BACKGROUND
  • Silverman 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: 17141314BACKGROUND
  • Filoux 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: 23742556BACKGROUND
  • Lethiecq 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: 23007770BACKGROUND
  • Mamou 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.

  • Silverman 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.

MeSH Terms

Conditions

Vitreous DetachmentDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Eye DiseasesRetinal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ronald H Silverman, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

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

Locations