Collecting Data on Retinal Blood Blood Flow and Blood Vessel Shape/Appearance Using an Investigational Device, XyCAM CRE, and to Then Compare Those Images With Images Collected From a Patient's Routine Clinical Examination.

Starting soon

Conditions studied: Microvascular Disease, Retinal Disease

In brief

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.

Key facts

Study ID

NCT07641738

Run by

Stuart Terry Eye Associates

People needed

350

Starts

2026-06-15

Expected to finish

2030-06-15

Last updated by the study team

2026-06-11

Who can join

Age: 21 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 is 21 years old with binocular vision.

You may not qualify if…

• 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.
• The Subject has more than 15 dioptors of refractive error. The Subject is less that 21 years of age. The Subject is unable to follow instructions or otherwise unable to complete the study procedures.
• The Subject has medical conditions such as nystagmus that will likely prevent the Subject from being able to hold their gaze steady during imaging, reducing the likelihood that high quality data can be acquired from the Subject.
• The Subject is pregnant.

Where it is running

• Stuart Terry Eye Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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