The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00633854
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Riverside Research Institute
Information provided by:
Weill Medical College of Cornell University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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. We 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 Procedure: Ultrasound examination

Detailed Description:

In this study, we will deploy annular-array systems and assess their experimental and clinical utility for ophthalmic imaging. We hypothesize that a 20-MHz annular array will detect posterior vitreous detachment (PVD) more reliably than a conventional single element ultrasound system. Clinically, we will test the hypothesis that 20-MHz annular arrays improve detection of PVD, an important risk factor for disease progression in diabetic retinopathy. Diabetic retinopathy is the leading cause of blindness in the working population (25 to 65 years) and the third major cause of legal blindness in the U.S.

We propose to carry out a study of 30 human subjects, aged 60 years or above, in whom PVD is likely to be present as a consequence of normal aging. The study will compare the ability to detect PVD using a commercial ophthalmic ultrasound system equipped with 10- and 20-MHz sector scan probes (Cinescan A/B-S, Quantel Medical), and OCT (OCT/SLO, Ophthalmic Technologies, Inc.), and the 20-MHz annular array. The annular array will be used with synthetic focusing and simulated single-element mode. The end point will be the fraction of eyes in which the PVD is visualized with each technique. This comparison is designed to demonstrate the improvement in our ability to visualize this pathologic entity using the advanced signal processing modes to be explored in this study. PVD can represent a risk factor for retinal detachment and retinal neovascularization in diabetics and localization of vitreoretinal traction points may be crucial for management. The present study, however, is limited to visualization of PVD in older normal subjects, about 75% of which would be expected to have PVD present. Thus, our aim is purely to develop an improved imaging modality rather than demonstrating its clinical efficacy in management of diabetic retinopathy or other ocular diseases.

The imaging technologies that we are developing could potentially result in patents or other intellectual property, which would be managed by the Cornell Research Foundation and Riverside Research Institute. This is alluded to in the consent form for the sake of completeness.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: High-frequency-ultrasound Annular Arrays for Small Animal and Ophthalmic Imaging
Study Start Date : February 2008
Actual Primary Completion Date : April 30, 2010
Actual Study Completion Date : April 30, 2010
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
1
30 volunteer subjects who are age 60 and older
 Procedure: Ultrasound examination
Immersion Ultrasound Exam: In the immersion technique, the patient lies down on the examination table. A steridrape with a central aperture is used to form a water-tight seal around the eye. After installation of 2 drops of 0.5% proparacaine HCl, a wire lid speculum is used to hold the patient's lids open. Warm 0.9% sterile saline solution is then used to create a waterbath about 1/2 inch deep to provide acoustic coupling between the transducer and the eye. The transducer (either the 10- and 20-MHz sector scan probe or the annular array) is placed in the waterbath, but does not touch the eye.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. detection of PVD in the posterior pole [ Time Frame: outcome measured at time of examination ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ophthalmology practice
Criteria

Inclusion Criteria:

  • Subjects should be age 60 or older with possible posterior vitreous detachment in the back of the eye.

Exclusion Criteria:

  • none
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00633854


Locations
Layout table for location information
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Riverside Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Ronald H Silverman, PhD Weill Medical College of Cornell University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Ronald H. Silverman, PhD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00633854    
Other Study ID Numbers: EB008606
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Keywords provided by Weill Medical College of Cornell University:
annular array ultrasound
ophthalmic ultrasound
posterior vitreous detachment (PVD)
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitreous Detachment
Eye Diseases