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NOT YET RECRUITING
NCT07641738

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.

Sponsor: Stuart Terry Eye Associates

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of Patients With Retinal Disorders Utilizing the XyCAM CRE Camera.

Key Details

Gender

All

Age Range

21 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2026-06-15

Completion Date

2030-06-15

Last Updated

2026-06-11

Healthy Volunteers

Yes

Interventions

DEVICE

XyCAM CRE Imaging

The 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.

Locations (1)

Stuart Terry Eye Associates

San Antonio, Texas, United States