The primary objective of the XyCAM CRE Camera Study is to evaluate retinal blood flow, choroidal blood flow, and retinal structural features and their association with the progression and characterization of retinal diseases using the XyCAM CRE Camera. The XyCAM CRE is an investigational, noninvasive optical imaging instrument manufactured by Vasoptic Medical, Inc.
XyCAM CRE imaging data will be collected and compared with established retinal imaging modalities currently used in ophthalmic clinical practice, including Color Fundus Photography (CFP), Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA), and Fluorescein Angiography (FA). Imaging data obtained from XyCAM CRE and reference modalities will be assessed to investigate correlations, agreement, and differences between measurements in order to evaluate the potential of XyCAM CRE to provide complementary diagnostic and disease management information in retinal disease.
Secondary objectives of the study include:
Comparing image quality and image-derived information obtained from XyCAM CRE with other clinical reference imaging modalities across different operators and a diverse study population representative of the general population; Investigating the relationship between XyCAM CRE imaging data and established clinical indicators of glaucoma, macular degeneration, hypertensive retinopathy, diabetic retinopathy, inherited retinal disease, and retinal vascular disease.
The Subject present to the ophthalmology/optometry clinic for eye examination. A signed/dated consent form has been obtained from a Subject who is capable of giving informed consent and compliant with the restrictions and requirements if the protocol.
The Subject has significant media opacity (eg: a significant corneal scar) The Subject's medical history or health status suggests that the Subject may have an adverse reaction to administration of tropicamide or fluorescein dye.
Adult patient with or without the presence of Retinal Disease, who meets the Inclusion/Exclusion Criteria.
Cohort
Prospective
XyCAM CRE Imaging
DeviceThe investigational XyCAM CRE imaging system will be used to acquire retinal blood flow and structural imaging data. No therapeutic intervention is administered; the device is used for observational imaging and data collection only.
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Treatment groupsSee each treatment group below.
Correlation of XyCAM CRE retinal blood flow measurements with reference retinal imaging modalities in retinal disease
Retinal blood flow (RBF) data will be obtained using XyCAM CRE imaging and compared with retinal imaging modalities currently used as standard of care in ophthalmology, including Color Fundus Photography (CFP), Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA), and Fluorescein Angiography (FA). Measurements obtained from XyCAM CRE and reference imaging modalities will be assessed for correlation, agreement, and differences to evaluate the potential of XyCAM CRE to provide complementary information for the diagnosis and management of retinal disease.
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