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.
Evaluation of Patients With Retinal Disorders Utilizing the XyCAM CRE Camera.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
- Laser Speckle Contrast Imaging (LSCI) using the investigational XyCAM CRE system; and
- 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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yvette L Macias, BA in Biology and Chemistry
- Número de teléfono: 210-600-0040
- Correo electrónico: yvettem@lenzaadmin.com
Ubicaciones de estudio
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Texas
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San Antonio, Texas, Estados Unidos, 78212
- Stuart Terry Eye Associates
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Contacto:
- Yvette L Macias, BA in Biology and Chemistry
- Número de teléfono: 210-600-0040
- Correo electrónico: yvettem@lenzaadmin.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Group A, Healthy Subjects
Subjects with no retinal disease present upon examination.
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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.
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Group B, Subjects with Moderate to Severe Glaucoma
Subjects diagnosed with moderate to severe glaucoma in at least one eye, as determined by the Hodapp-Anderson criteria for glaucomatous visual field loss.
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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.
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Group C, Glaucoma Suspect or Mild Glaucoma Subjects
Subjects diagnosed as glaucoma suspects or with mild glaucoma in at least one eye based on clinical findings including elevated intraocular pressure (IOP), suspicious optic nerve appearance, borderline or early visual field abnormalities, and/or retinal nerve fiber layer (RNFL) thinning identified by Optical Coherence Tomography (OCT).
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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.
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Group D, Subjects with AMD
The Subject has been diagnosed with AMD based on clinical diagnostic criteria for AMD
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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.
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Group E, Subjects with Diabetic Eye Disease
The Subject has been diagnosed via clinical diagnostic guidelines with diabetic eye disease, such as non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), and diabetes without significant ocular pathology visible on fundus examination.
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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.
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Group F, Subjects with Hypertensive Retinopathy
The Subject has been diagnosed with Hypertensive Retinopathy based on clinical diagnostic criteria for Hypertensive Retinopathy.
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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.
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Group G, Pilot Subjects with other ocular pathologies and interventions
The Subject is determined by the Principal Investigator to have pathology or has undergone interventions that may significantly reduce or elevate ocular blood flow; and Subjects in this group are recruited on a pilot basis to assess the preliminary (with limited statistical power) promise of RBF monitoring in a diverse set of pathologies.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Correlation of XyCAM CRE retinal blood flow measurements with reference retinal imaging modalities in retinal disease
Periodo de tiempo: From enrollment through completion of Visit 4 (approximately 12-18 months). Participants will complete four testing visits scheduled approximately 4 months apart (±2 months).
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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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From enrollment through completion of Visit 4 (approximately 12-18 months). Participants will complete four testing visits scheduled approximately 4 months apart (±2 months).
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Vinnett A, Kandukuri J, Le C, Cho KA, Sinha A, Asanad S, Thompson G, Chen V, Rege A, Saeedi OJ. Dynamic Alterations in Blood Flow in Glaucoma Measured with Laser Speckle Contrast Imaging. Ophthalmol Glaucoma. 2022 May-Jun;5(3):250-261. doi: 10.1016/j.ogla.2021.10.005. Epub 2021 Oct 18.
- 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.
- 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.
- 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.
- 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.
- 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.
- Burgansky-Eliash Z, Barash H, Nelson D, Grinvald A, Sorkin A, Loewenstein A, Barak A. Retinal blood flow velocity in patients with age-related macular degeneration. Curr Eye Res. 2014 Mar;39(3):304-11. doi: 10.3109/02713683.2013.840384. Epub 2013 Oct 22.
- Chen L, Yuan M, Sun L, Wang Y, Chen Y. Evaluation of microvascular network with optical coherence tomography angiography (OCTA) in branch retinal vein occlusion (BRVO). BMC Ophthalmol. 2020 Apr 19;20(1):154. doi: 10.1186/s12886-020-01405-0.
- Matsumoto M, Suzuma K, Yamada Y, Tsuiki E, Fujikawa A, and Kitaoka T (2013) "Retinal Blood Flow Levels Measured by Laser Speckle Flowgraphy in Central Retinal Vein Occlusion as a Predictive Factor for Ischemia and Visual Loss," Investigative Ophthalmology & Visual Science 54, 5126-5126.
- Tayyari F, Khuu LA, Flanagan JG, Singer S, Brent MH, Hudson C. Retinal Blood Flow and Retinal Blood Oxygen Saturation in Mild to Moderate Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 2015 Oct;56(11):6796-800. doi: 10.1167/iovs.15-17481.
- Rosen RB, Andrade Romo JS, Krawitz BD, Mo S, Fawzi AA, Linderman RE, Carroll J, Pinhas A, Chui TYP. Earliest Evidence of Preclinical Diabetic Retinopathy Revealed Using Optical Coherence Tomography Angiography Perfused Capillary Density. Am J Ophthalmol. 2019 Jul;203:103-115. doi: 10.1016/j.ajo.2019.01.012. Epub 2019 Jan 26.
- Nippert AR, Newman EA. Regulation of blood flow in diabetic retinopathy. Vis Neurosci. 2020 Jul 20;37:E004. doi: 10.1017/S0952523820000036.
- Shiga Y, Kunikata H, Aizawa N, Kiyota N, Maiya Y, Yokoyama Y, Omodaka K, Takahashi H, Yasui T, Kato K, Iwase A, Nakazawa T. Optic Nerve Head Blood Flow, as Measured by Laser Speckle Flowgraphy, Is Significantly Reduced in Preperimetric Glaucoma. Curr Eye Res. 2016 Nov;41(11):1447-1453. doi: 10.3109/02713683.2015.1127974. Epub 2016 May 9.
- Abegao Pinto L, Willekens K, Van Keer K, Shibesh A, Molenberghs G, Vandewalle E, Stalmans I. Ocular blood flow in glaucoma - the Leuven Eye Study. Acta Ophthalmol. 2016 Sep;94(6):592-8. doi: 10.1111/aos.12962. Epub 2016 Feb 19.
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Otros números de identificación del estudio
- 20260857
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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