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Translational Clinical Trials Center Reading Center

Summary:

Housed within Casey Eye Institute is the Translational Clinical Trials Center Reading Center (TCTC RC), which has a collection of talented physicians and staff who are focused on preclinical evaluation, clinical trial design and endpoint development of outcome measurements. Our center can offer expertise in quality control and provide analysis of data collected.

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    Services

    • Clinical trial design for retinal degenerative diseases ( Support service )

      "The TCTC RC has gained significant regulatory and organizational experience by being lead participants in ongoing clinical trials. We understand there is a strong need for a reading center that can work with commercial and academic organizations to design clinical trials for retinal disease. Thus, we work with Sponsors to develop standard data analysis requirements for eligibility, treatment criteria and pathological end points. Our team of specialists have extensive experience in Ophthalmological gene therapy trials."

    • Electrodiagnostics ( Material analysis service )

      "Casey Eye Institute uses all the techniques available to diagnose and treat retinal and vitreal diseases."

    • Endpoint analysis of clinical trial measures ( Data analysis service )

      Service includes "TCTC RC analysis of ophthalmic clinical trial measures with specific emphasis on retinal visual field, imaging and electrophysiological endpoints."

    • Ophthalmic image analysis using web interface ( Data analysis service )

      "The TCTC RC uses custom-designed software that allows clinical trial sites to upload ophthalmic images and data through a web-based interface. After images are uploaded and graded for quality, our team of specialists read the images, and in some cases provide additional analytic services. The TCTC RC software has built-in functionality that allows us to configure a customized process and end points for each clinical trial.

      Clinical trial sites and sponsors have the ability to view the progress of their own information in the system via the world wide web using a standard browser.

      All clinical trial information is deidentified, uploaded via our website stored in our database, which resides on enterprise-class servers at our secure data center.

      The data center and servers are maintained by a specialized team of information technology professionals. Data is backed up daily and stored off-site, and the servers in our data center are protected by encryption and transaction auditing."

    • Ophthalmic imaging ( Material analysis service )

      "The Casey Eye Institute's photography and ultrasound services provide vital information for diagnosing and treating eye diseases.

      PHOTOGRAPHY:
      The Ophthalmic Imaging service at the Casey Eye Institute has a staff of dedicated professionals who provide a variety of high-level services to staff and patients. We are a fully digital ophthalmic imaging department.

      ULTRASOUND:
      The Diagnostic Ultrasound service at the Casey Eye Institute uses standardized echography, an important adjunct to computed tomography (CT) and magnetic resonance imaging (MRI). It is essential in diagnosing vitreoretinal disorders, tumors of the eye and orbit, and eye trauma.

      SERVICES INCLUDE:
      Slitlamp photography / Gonio photography
      Spectral domain and time domain optical coherence tomography
      Anterior segment fluorescein angiography
      Endothelial specular photomicrography
      Biometric ruling for IOL calculations
      External ocular photography
      Diagnostic A and B scan ultrasonography
      High frequency biomicroscopy for anterior chamber imaging
      Handheld spectral domain OCT
      Retinal photography:
      color
      red-free
      infrared
      autofluorescence
      Angiography
      fluorescein
      indocyanine green"

    • Site certification for retinal imaging, visual field testing and retinal electrophysiology human clinical trials ( Support service )

      "The initial certification of equipment and staff, as well as maintenance of this certification, is of utmost importance to assure standard and reliable data collection by clinical sites. Thus, we have developed rigorous certification procedures for clinical site staff and equipment. The certification procedures are documented in our SOP's."


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    Last updated: 2012-08-10T17:17:01.687-05:00

    Copyright © 2016 by the President and Fellows of Harvard College
    The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016