Annular Array Ultrasound in Ophthalmology

January 29, 2019 updated by: Ronald H. Silverman, Columbia University

High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

University-based Ophthalmology Practice

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • under age 60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Subjects will be examined with both the 20MHz annular array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Eye Institute (NEI)
Riverside Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (ESTIMATE)

August 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAF3057
  • R21EY024434 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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