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.

NCT07641738 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 20260857
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Microvascular Disease; Retinal Disease

Keywords

XyCAM CRE; XyCAM RI

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (7)

Group A, Healthy Subjects

Subjects with no retinal disease present upon examination.

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.

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).

Device: XyCAM CRE Imaging

Group D, Subjects with AMD

The Subject has been diagnosed with AMD based on clinical diagnostic criteria for AMD

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.

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.

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.

Device: XyCAM CRE Imaging

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.

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

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stuart Terry Eye Associates: lead

Study Sites (1)

Stuart Terry Eye Associates

San Antonio, Texas, 78212, United States

Location

Related Publications (17)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 24147793 BACKGROUND

• 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.

  PMID: 32306978 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26567792 BACKGROUND

• 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.

  PMID: 30689991 BACKGROUND

• Nippert AR, Newman EA. Regulation of blood flow in diabetic retinopathy. Vis Neurosci. 2020 Jul 20;37:E004. doi: 10.1017/S0952523820000036.

  PMID: 32684188 BACKGROUND

• 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.

  PMID: 34673279 BACKGROUND

• 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.

  PMID: 27159148 BACKGROUND

• 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.

  PMID: 26895610 BACKGROUND

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Yvette L Macias, BA in Biology and Chemistry

CONTACT

210-600-0040; yvettem@lenzaadmin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 11, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): June 15, 2030
• Last Updated: June 11, 2026

Record last verified: 2026-05

Locations

US (1)