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Annular Array Ultrasound in Ophthalmology

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ClinicalTrials.gov Identifier: NCT01415037
Recruitment Status : Enrolling by invitation
First Posted : August 11, 2011
Last Update Posted : May 18, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Posterior Vitreous Detachment Diabetic Retinopathy Procedure: annular array ultrasound exam

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.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging
Study Start Date : October 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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
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.


Outcome Measures

Primary Outcome Measures :
  1. Change in detection of posterior vitreous detachment: 20MHz annular array versus 10MHz single element [ Time Frame: Subjects will be examined with both the 20MHz annular array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration. ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
University-based Ophthalmology Practice
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • under age 60
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415037


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Riverside Research Institute
National Eye Institute (NEI)
Investigators
Principal Investigator: Ronald H Silverman, PhD Columbia University
More Information

Publications:

Responsible Party: Ronald H. Silverman, Professor of Ophthamlic Science, Columbia University
ClinicalTrials.gov Identifier: NCT01415037     History of Changes
Other Study ID Numbers: AAAF3057
R21EY024434 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Ronald H. Silverman, Columbia University:
Annular Array Ultrasound
Ultrasound Exam
Posterior Vitreous Detachment
PVD
Diabetic Retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Vitreous Detachment
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases