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.

Официальное название

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

Обзор

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.

Подробное описание

This XyCAM CRE Camera Study is a prospective longitudinal observational cohort imaging study. It is a non-randomized, non-masked, early feasibility study designed to collect retinal imaging data from healthy adults with normal retinal findings and from patients diagnosed with retinal and ocular diseases.

The study will consist of two phases: 1) screening and 2) testing. Patients presenting for routine ophthalmic standard of care evaluations will be screened for eligibility.

Eligible participants will complete four testing visits scheduled approximately 4 months apart (±2 months). At each testing visit, the Principal Investigator (PI) and designated study personnel will document participants' clinical status, obtain intraocular pressure (IOP) and blood pressure (BP) measurements, and acquire repeat XyCAM CRE retinal images. No additional follow-up will be required after completion of Visit 4 procedures.

The XyCAM CRE is an investigational, noninvasive optical imaging system manufactured by Vasoptic Medical, Inc. The device acquires rapid sequential digital retinal images while illuminating the retina with a low-power laser. Proprietary software algorithms analyze the image sequences to estimate retinal blood flow dynamics and generate additional quantitative vascular and structural measurements that may have diagnostic or disease-monitoring value.

The purpose of this study is to investigate the clinical utility of retinal and choroidal blood flow imaging and to evaluate the potential role of XyCAM CRE-derived measurements in the diagnosis and management of ocular disease. Up to 350 participants will be enrolled at Stuart Terry Eye Associates

During study visits, retinal imaging data obtained using XyCAM CRE will be compared with data obtained from 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). The study will utilize:

1. Laser Speckle Contrast Imaging (LSCI) using the investigational XyCAM CRE system; and 2. Retrospective and/or clinically acquired reference imaging data from CFP, OCT, OCTA, and FA obtained using standard clinical imaging systems.

LSCI-based retinal blood flow imaging has demonstrated potential as a diagnostic biomarker for assessing disease presence, severity, and progression. Accordingly, LSCI technology implemented in the investigational XyCAM CRE system is the primary imaging modality under evaluation in this study.

XyCAM CRE will be used to obtain retinal blood flow (RBF) measurements from one or more retinal regions. Imaging data will be stored in de-identified form and analyzed to generate region-specific RBF metrics for comparison with participant clinical status and measurements derived from reference imaging modalities.

This study also seeks to establish a broader reference dataset of retinal blood flow measurements obtained from both healthy and diseased eyes. Currently, there is limited widely accepted normative retinal blood flow data available for clinical comparison. Data collected in this study may contribute to future statistical analyses and support the development of reference datasets for subsequent clinical and research applications.

Alterations in retinal perfusion are associated with multiple vision-threatening ocular conditions, including glaucoma, diabetic retinopathy, retinal vein occlusion, and age-related macular degeneration, as well as systemic and neurologic disorders such as cardiovascular disease and cognitive impairment. In addition, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy may influence retinal blood flow, suggesting a potential role for retinal perfusion imaging in treatment monitoring and clinical decision-making.

Through longitudinal retinal and choroidal blood flow imaging, this study aims to further characterize the relationship between microvascular perfusion abnormalities and the progression of common retinal diseases.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Correlation of XyCAM CRE retinal blood flow measurements with reference retinal imaging modalities in retinal disease [Срок оценки: From enrollment through completion of Visit 4 (approximately 12-18 months). Participants will complete four testing visits scheduled approximately 4 months apart (±2 months).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Stuart Terry Eye Associates — San Antonio

Публикации

• Wang J, Mansoor S, Wu JY, Kilby C, Forbes H, Kapoor R, Ward S, Zhou J, Williams K, Levin MR, Sundararajan S, Magder L, Sinha A, Rege A, Alexander JL. Retinal Blood Flow Decreases after Treatment with Bevacizumab for Retinopathy of Prematurity. Ophthalmol Sci. 2025 Jun 16;5(6):100857. doi: 10.1016/j.xops.2025.100857. eCollection 2025 Nov-Dec. PMID 40697391
• Cho KA, Rege A, Jing Y, Chaurasia A, Guruprasad A, Arthur E, Cabrera DeBuc D. Portable, non-invasive video imaging of retinal blood flow dynamics. Sci Rep. 2020 Nov 19;10(1):20236. doi: 10.1038/s41598-020-76407-5. PMID 33214571
• Porwal Y, Elbash K, Kilby C, Wu J-Y, Oechsli S, Mansoor S, Ventimiglia M, Sinha A, Im L, Rege A, and Saeedi O (2025) "Assessment of Retinal Blood Flow Dysregulation in Glaucoma Using Laser Speckle Contrast Imaging," Investigative Ophthalmology & Visual Science 66, 3320-3320.
• Kalarn S, Cho K-A, Vinnett A, Asanad S, Baroni M, Pottenburgh J, Rege A, and Saeedi O (2020) "Repeatability and Reproducibility of the Xycam Ri across Multiple Operators," Investigative Ophthalmology & Visual Science 61, 5321-5321.
• Nitta F, Kunikata H, Aizawa N, Omodaka K, Shiga Y, Yasuda M, Nakazawa T. The effect of intravitreal bevacizumab on ocular blood flow in diabetic retinopathy and branch retinal vein occlusion as measured by laser speckle flowgraphy. Clin Ophthalmol. 2014 Jun 11;8:1119-27. doi: 10.2147/OPTH.S62022. eCollection 2014. PMID 24959068
• Wang J, Jiang J, Zhang Y, Qian YW, Zhang JF, Wang ZL. Retinal and choroidal vascular changes in coronary heart disease: an optical coherence tomography angiography study. Biomed Opt Express. 2019 Mar 4;10(4):1532-1544. doi: 10.1364/BOE.10.001532. eCollection 2019 Apr 1. PMID 31061756
• DeBuc DC, Rege A, Smiddy WE. Use of XyCAM RI for Noninvasive Visualization and Analysis of Retinal Blood Flow Dynamics During Clinical Investigations. Expert Rev Med Devices. 2021 Mar;18(3):225-237. doi: 10.1080/17434440.2021.1892486. Epub 2021 Mar 18. PMID 33635742
• Panova IE, Ermak EM, Shaimova TA, Shaimova VA. [Macular choroidal blood flow in concurrent age-related macular degeneration and primary open-angle glaucoma]. Vestn Oftalmol. 2016 Jul-Aug;132(4):48-53. doi: 10.17116/oftalma2016132448-53. Russian. PMID 27600895

Идентификаторы

NCT: NCT07641738 · 20260857

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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