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Investigational Use - Ocular Research


To enable clinical research that requires ocular blood flow measurements, Vasoptic offers certain modifications to the XyCAM RI to meet application-specific requirements. Any custom-modified version of the XyCAM RI is called the XyCAM CRE, or XyCAM Custom Research Equipment, and is intended for research use only. The investigational XyCAM CRE leverages the core design and construction of the clinical-grade XyCAM RI but customizations make it inappropriate for use in the practice of medicine. Examples of customization that can be provided by Vasoptic include:

  • Mounting on an articulating arm with additional hand/foot controlled image acquisition for use on research subjects in the supine position

  • Limited changes to the imaging software to support research-friendly de-identified data acquisition or to accommodate user requirements of image acquisition over longer durations.  

  • Limited changes to the image analysis software to support certain analytical needs of research projects via automated and semi-automated means.  

XyCAM CRE, like XyCAM RI, uses proprietary laser speckle contrast imaging to obtain ocular blood flow data from the posterior segment, but additionally features:

  • Customized visualization with of video-rate ocular blood flow data,

  • Customized spatio-temporal analysis of blood flow dynamics,

  • Customized configuration for easy data acquisition for research studies.

Data obtained by XyCAM CRE is complementary to structural data obtained using fundus photography and OCT, and also to vascular perfusion status obtained by fluorescein/ICG/OCT-angiography.

IMPORTANT: The XyCAM CRE is an investigational device suitable for Research Use Only. The XyCAM CRE has not been reviewed by any regulatory authority and should be used in compliance with research protocols overseen by a competent Ethics Committee and other governing laws that apply. 

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