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.

June 6, 2026 updated by: Oday Alsheikh M.D., Stuart Terry Eye Associates

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78212
        • Stuart Terry Eye Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patient with or without the presence of Retinal Disease, who meets the Inclusion/Exclusion Criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
From enrollment through completion of Visit 4 (approximately 12-18 months). Participants will complete four testing visits scheduled approximately 4 months apart (±2 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stuart Terry Eye Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

June 15, 2030

Study Registration Dates

First Submitted

June 6, 2026

First Submitted That Met QC Criteria

June 6, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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