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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00277784
Other study ID # AIUM #1-2005
Secondary ID
Status Completed
Phase N/A
First received January 12, 2006
Last updated March 4, 2008
Start date July 2005
Est. completion date June 2006

Study information

Verified date March 2008
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The macula is the site of central vision within the retina. The retina is oxygenated by the underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques can reveal much about the structure of the retina, ultrasound allows imaging of the choroid and deeper tissues. This study will investigate use of high frequency (20 MHz) ultrasound for imaging of the retina and choroid in patients with age-related macular degeneration, a prime cause of blindness. The investigation will involve use of novel post-processing methodologies to achieve maximum resolution of the fine tissue structures involved in this disease.


Description:

Age-related macular degeneration (AMD), a condition affecting over 40% of individuals 70 years or age or more, causes progressive loss of central vision. Photocoagulation has long been used to slow the progress of AMD, but new vision-preserving methods are currently under investigation. Because destroyed photoreceptors are permanently lost, early management is essential for preservation of vision. The aim of this project will be to study AMD using a suite of new high-resolution ultrasound imaging techniques that have been developed. Specifically, high-resolution ultrasound will be used to generate images of the retina and choroid, including perfusion measurements using slow-flow methods developed by our research group. Ultrasound studies will be performed in conjunction with optical coherence tomography (OCT) imaging in a series of patients and age-matched control subjects with the aim of determining if choroidal thickness and/or perfusion might be used as an early indicator of AMD and thus aid in patient management.

We will study 20 subjects diagnosed with AMD. We will attempt to have an approximately equal number of subjects with wet and dry forms of AMD. A control group consisting of 20 non-AMD age-matched subjects will also be recruited. Ultrasound scan sequences will consist of B-mode images of the macula and surrounding tissues.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years to 90 Years
Eligibility Inclusion Criteria:

Age related macular degeneration age matched control

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound examination
one ultrasound examination

Locations

Country Name City State
United States Weill Cornell Medical College New York New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Coleman DJ, Silverman RH, Chabi A, Rondeau MJ, Shung KK, Cannata J, Lincoff H. High-resolution ultrasonic imaging of the posterior segment. Ophthalmology. 2004 Jul;111(7):1344-51. — View Citation

Silverman RH. Ultrasound versus AC OCT. J Cataract Refract Surg. 2005 Aug;31(8):1475; author reply 1475-7. — View Citation

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