Microvascular DiseaseNCT07641738
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.
An observational study of Microvascular Disease and Retinal Disease, run by Stuart Terry Eye Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Microvascular Disease, Retinal Disease
- What is being tested?
- XyCAM CRE Imaging
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 15 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patient with or without the presence of Retinal Disease, who meets the Inclusion/Exclusion Criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stuart Terry Eye Associates
San Antonio, Texas, 78212
Yvette L Macias, BA in Biology and Chemistry, 210-600-0040, yvettem@lenzaadmin.com
About this study
Official title: 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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Microvascular Disease, Retinal Disease
- Being tested
- XyCAM CRE Imaging
- Keywords
- XyCAM CRE, XyCAM RI
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XyCAM CRE ImagingDevice
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 group | Role | What they receive |
|---|---|---|
| Group A, Healthy Subjects | Subjects with no retinal disease present upon examination. Receives: Device: XyCAM CRE Imaging | |
| 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. Receives: Device: XyCAM CRE Imaging | |
| 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). Receives: Device: XyCAM CRE Imaging | |
| Group D, Subjects with AMD | The Subject has been diagnosed with AMD based on clinical diagnostic criteria for AMD Receives: Device: XyCAM CRE Imaging | |
| 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. Receives: Device: XyCAM CRE Imaging | |
| Group F, Subjects with Hypertensive Retinopathy | The Subject has been diagnosed with Hypertensive Retinopathy based on clinical diagnostic criteria for Hypertensive Retinopathy. Receives: Device: XyCAM CRE Imaging | |
| 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. Receives: Device: XyCAM CRE Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of XyCAM CRE retinal blood flow measurements with reference retinal imaging modalities in retinal disease
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.
Measured: From enrollment through completion of Visit 4 (approximately 12-18 months). Participants will complete four testing visits scheduled approximately 4 months apart (±2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Microvascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stuart Terry Eye Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oday Alsheikh M.D., Stuart Terry Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641738
- Sponsor's protocol ID
- 20260857
- Status last verified
- May 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 40697391Cho 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.
PubMed 33214571Porwal 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.
PubMed 24959068Wang 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.
PubMed 31061756DeBuc 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.
PubMed 33635742Panova 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.
PubMed 27600895Burgansky-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.
PubMed 24147793Chen 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.
PubMed 32306978Matsumoto 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.
PubMed 26567792Rosen 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.
PubMed 30689991Nippert AR, Newman EA. Regulation of blood flow in diabetic retinopathy. Vis Neurosci. 2020 Jul 20;37:E004. doi: 10.1017/S0952523820000036.
PubMed 32684188Vinnett 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.
PubMed 34673279
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Retinal Disorders Utilizing the XyCAM CRE Camera.
- ClinicalTrials.gov ID
- NCT07641738
- Acronym / sponsor ID
- 20260857
- Conditions
- Microvascular Disease, Retinal Disease
- Keywords
- XyCAM CRE, XyCAM RI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Stuart Terry Eye AssociatesUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group A, Healthy Subjects | – | Device: XyCAM CRE ImagingSubjects with no retinal disease present upon examination. |
| Group B, Subjects with Moderate to Severe Glaucoma | – | Device: XyCAM CRE ImagingSubjects diagnosed with moderate to severe glaucoma in at least one eye, as determined by the Hodapp-Anderson criteria for glaucomatous visual field loss. |
| Group C, Glaucoma Suspect or Mild Glaucoma Subjects | – | Device: XyCAM CRE ImagingSubjects 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). |
| Group D, Subjects with AMD | – | Device: XyCAM CRE ImagingThe Subject has been diagnosed with AMD based on clinical diagnostic criteria for AMD |
| Group E, Subjects with Diabetic Eye Disease | – | Device: XyCAM CRE ImagingThe 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. |
| Group F, Subjects with Hypertensive Retinopathy | – | Device: XyCAM CRE ImagingThe Subject has been diagnosed with Hypertensive Retinopathy based on clinical diagnostic criteria for Hypertensive Retinopathy. |
| Group G, Pilot Subjects with other ocular pathologies and interventions | – | Device: XyCAM CRE ImagingThe 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with or without the presence of Retinal Disease, who meets the Inclusion/Exclusion Criteria.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XyCAM CRE ImagingThe 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. | Device | Group A, Healthy Subjects, Group B, Subjects with Moderate to Severe Glaucoma, Group C, Glaucoma Suspect or Mild Glaucoma Subjects, Group D, Subjects with AMD, Group E, Subjects with Diabetic Eye Disease, Group F, Subjects with Hypertensive Retinopathy, Group G, Pilot Subjects with other ocular pathologies and interventions |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 40697391Wang 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.
- Background: PubMed 33214571Cho 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.
- BackgroundPorwal 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.
- BackgroundKalarn 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.
- Background: PubMed 24959068Nitta 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.
- Background: PubMed 31061756Wang 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.
- Background: PubMed 33635742DeBuc 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.
- Background: PubMed 27600895Panova 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.
- Background: PubMed 24147793Burgansky-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.
- Background: PubMed 32306978Chen 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.
- BackgroundMatsumoto 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.
- Background: PubMed 26567792Tayyari 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.
- Individual participant dataSharing planned: Undecided
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Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microvascular Disease and Retinal Disease, run by Stuart Terry Eye Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvette L Macias, BA in Biology and Chemistry (210-600-0040, yvettem@lenzaadmin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07641738, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.