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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 12, 2006 | ||||||||
| Last Updated Date | March 4, 2008 | ||||||||
| Start Date ICMJE | July 2005 | ||||||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00277784 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | High-Resolution Ultrasound Imaging of the Retina and Choroid for Detection on Age Related Macular Degeneration | ||||||||
| Official Title ICMJE | High-Resolution Ultrasound Imaging of the Retina and Choroid | ||||||||
| Brief 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. |
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| Detailed 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case-Only, Prospective | ||||||||
| Condition ICMJE | Age Related Macular Degeneration | ||||||||
| Intervention ICMJE | Procedure: Ultrasound examination | ||||||||
| Study Arms / Comparison Groups | Individuals with age related macular degeneration | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 40 | ||||||||
| Completion Date | June 2006 | ||||||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Age related macular degeneration age matched control Exclusion Criteria: none |
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| Gender | Both | ||||||||
| Ages | 45 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00277784 | ||||||||
| Responsible Party | Ronald H. Silverman, PhD, Weill Cornell Medical College | ||||||||
| Study ID Numbers ICMJE | AIUM #1-2005 | ||||||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||||||
| Verification Date | March 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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