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.

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Stuart Terry Eye Associates
Study ID
NCT07641738
Status
Not Yet Recruiting

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Conditions

  • Microvascular Disease
  • Retinal Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • XyCAM CRE Imaging — DEVICE
    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.

Study Details

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 Dates

Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Jun 15, 2029
Completion
Jun 15, 2030

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Group A, Healthy Subjects
    Subjects with no retinal disease present upon examination.
  • Arm: 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.
  • Arm: 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).
  • Arm: Group D, Subjects with AMD
    The Subject has been diagnosed with AMD based on clinical diagnostic criteria for AMD
  • Arm: 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.
  • Arm: Group F, Subjects with Hypertensive Retinopathy
    The Subject has been diagnosed with Hypertensive Retinopathy based on clinical diagnostic criteria for Hypertensive Retinopathy.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stuart Terry Eye AssociatesSan AntonioTexas78212
Yvette L Macias, BA in Biology and Chemistry
[email protected]
210-600-0040

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Stuart Terry Eye Associates· San Antonio, TX

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