Annular Array Ultrasound in Ophthalmology

NCT ID: NCT01415037

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-12-31

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.

Detailed Description

The goal of this study is to develop and evaluate advanced annular-array transducer technology for rapid, high-definition imaging. The study will assess high frequency ultrasound (HFU, 40 & 20 MegaHertz) annular arrays in imaging posterior vitreous detachments (PVDs) associated with diabetic retinopathy, the leading cause of blindness in the US working-age population according to Prevent Blindness America. Current HFU instruments do not use linear arrays for such applications because of a variety of technical and cost reasons. Instead, current HFU instruments use mechanically scanned, single-element transducers, which provide fine-resolution images over a very limited depth of field (DOF). For ophthalmic applications, a shallow DOF causes most ocular anatomy to be imaged with poor definition compared to the in-focus region; therefore, because only a small portion of the eye is in focus at a given time, detection and assessment of ocular conditions such as PVD are prone to inaccuracies and false-negative determinations. Annular-array transducers offer a promising approach to significantly extend DOF and to increase the depth range over which fine-lateral resolution is provided. The investigators will validate system performance using animal experiments and human-subject examinations. First, in vivo animal experiments will be conducted to evaluate a 40-MegaHertz (MHz) annular array for anterior-segment imaging and a 20-MHz annular array for posterior segment and full-globe imaging. The investigators will test the hypothesis that 20-MHz annular arrays improve detection of PVD. Validation of this hypothesis will significantly improve our ability to assess disease status in diabetic retinopathy.

Conditions

Posterior Vitreous Detachment; Diabetic Retinopathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Annular Array Ultrasound

Subject with possible or with known posterior vitreous detachment. Subjects with diabetic retinopathy will receive annular array ultrasound exam.

annular array ultrasound exam

Intervention Type: PROCEDURE

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.

Interventions

annular array ultrasound exam

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• over age 60
• people with diabetic retinopathy or posterior vitreous detachments

Exclusion Criteria

• under age 60

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riverside Research Institute

OTHER

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Ronald H. Silverman

Professor of Ophthamlic Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald H Silverman, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19394754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18334358 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17141314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23742556 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23007770 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25613948 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21902166 (View on PubMed)

Other Identifiers

R21EY024434

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAF3057

Identifier Type: -

Identifier Source: org_study_id