- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00633854
High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging
High-frequency-ultrasound Annular Arrays for Small Animal and Ophthalmic Imaging
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Weill Cornell Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects should be age 60 or older with possible posterior vitreous detachment in the back of the eye.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
30 volunteer subjects who are age 60 and older
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
detection of PVD in the posterior pole
Time Frame: outcome measured at time of examination
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outcome measured at time of examination
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- Silverman RH, Ketterling JA, Mamou J, Coleman DJ. Improved high-resolution ultrasonic imaging of the eye. Arch Ophthalmol. 2008 Jan;126(1):94-7. doi: 10.1001/archopht.126.1.94.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EB008606
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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