Annular Array Ultrasound in Ophthalmology

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Riverside Research Institute
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Ronald H. Silverman, Columbia University
ClinicalTrials.gov Identifier:
NCT01415037
First received: July 25, 2011
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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 Intervention
Posterior Vitreous Detachment
Diabetic Retinopathy
Procedure: annular array ultrasound exam

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Detection of posterior vitreous detachment: 20MHz annular array versus 10MHz single element [ Time Frame: Subjects will be examined with both the 20MHz annunlar array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Annular Array Ultrasound
Subject with possible or with known posterior vitreous detachment. Subjects with diabetic retinopathy.
Procedure: annular array ultrasound exam
For this research study you will be asked to lie down on the exam table. A plastic drape with a central hole will be used to form a watertight seal around your eye. After giving you 2 drops of a numbing solution, warm 0.9% sterile saline solution (like natural tears) will be poured into the drape and it will cover your eye. The ultrasound camera will then be placed in the waterbath, but does not touch your eye. You will 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.

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 MHz) 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-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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

University-based Ophthalmology Practice

Criteria

Inclusion Criteria:

  • over age 60

Exclusion Criteria:

  • under age 60
  • unable to lay down on examination table
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Institute for Biomedical Imaging and Bioengineering (NIBIB)
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, 5R01EB008606
Study First Received: July 25, 2011
Last Updated: August 30, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
Annular Array Ultrasound
Ultrasound Exam
Posterior Vitreous Detachment
PVD
Diabetic Retinopathy

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

ClinicalTrials.gov processed this record on September 14, 2014