OCT Angiography for Retinopathy
(OCTA-RVD Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAmir Kashani, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Children, Pregnant, Glaucoma, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Axial Length Measurement Device, OCTA, Optical Coherence Tomography Angiography, Fundus Imaging, Spectral-Domain OCT Angiography, and Swept-Source OCT Angiography for retinopathy?
Research shows that Optical Coherence Tomography Angiography (OCTA) can effectively image the blood vessels in the eye, which is important for diagnosing and monitoring conditions like diabetic retinopathy. The use of advanced OCTA technologies, such as swept-source OCTA, provides high-resolution images that can help detect changes in the eye's blood vessels, potentially improving the management of retinopathy.
12345Is OCT Angiography safe for humans?
The research articles do not provide specific safety data for OCT Angiography, but they focus on its use in imaging and measuring eye structures, which suggests it is generally considered safe for these purposes.
36789How does OCT Angiography differ from other treatments for retinopathy?
OCT Angiography is unique because it provides high-resolution, three-dimensional images of the eye's blood vessels without needing contrast dyes, allowing for detailed monitoring and diagnosis of retinal diseases. This non-invasive imaging technique offers a wider field of view and higher resolution compared to traditional methods like fluorescein angiography, making it a valuable tool for early detection and disease monitoring.
110111213Eligibility Criteria
This trial is for individuals with retinal vascular diseases like diabetic retinopathy or retinal vein occlusion, as well as those with high blood pressure that may affect the retina. Participants should be able to undergo regular imaging tests to track changes in their eye condition over time.Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Imaging and Assessment
Subjects undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes
5 years
Regular visits as per standard-of-care
Follow-up
Participants are monitored for safety and effectiveness after imaging and assessments
6 months
2 visits (in-person)
Participant Groups
The study is testing different eye imaging techniques: Swept-Source OCT Angiography, Spectral-Domain OCT Angiography, Fundus Imaging, and Axial Length Measurement Device. It aims to observe how these methods can detect changes in the retina due to disease progression or treatment effects.
4Treatment groups
Experimental Treatment
Group I: Hypertension OnlyExperimental Treatment4 Interventions
Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
Group II: Diabetics with and without Diabetic Retinopathy OnlyExperimental Treatment4 Interventions
Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Group III: Diabetics w/ or w/o Diabetic Retinopathy & HypertensionExperimental Treatment4 Interventions
Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
Group IV: ControlsExperimental Treatment4 Interventions
Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wilmer Eye InstituteBaltimore, MD
Johns HopkinsBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Eye Institute (NEI)Collaborator
References
Imaging the Deep Choroidal Vasculature Using Spectral Domain and Swept Source Optical Coherence Tomography Angiography. [2022]To evaluate the deeper choroidal vasculature in eyes with various ocular disorders using spectral domain (SD) optical coherence tomography angiography (OCTA) and swept source (SS) OCTA.
Ultra-Widefield OCT Angiography. [2023]Optical Coherence Tomography Angiography (OCTA), a functional extension of OCT, has the potential to replace most invasive fluorescein angiography (FA) exams in ophthalmology. So far, OCTA's field of view is however still lacking behind fluorescence fundus photography techniques. This is problematic, because many retinal diseases manifest at an early stage by changes of the peripheral retinal capillary network. It is therefore desirable to expand OCTA's field of view to match that of ultra-widefield fundus cameras. We present a custom developed clinical high-speed swept-source OCT (SS-OCT) system operating at an acquisition rate 8-16 times faster than today's state-of-the-art commercially available OCTA devices. Its speed allows us to capture ultra-wide fields of view of up to 90 degrees with an unprecedented sampling density and hence extraordinary resolution by merging two single shot scans with 60 degrees in diameter. To further enhance the visual appearance of the angiograms, we developed for the first time a three-dimensional deep learning based algorithm for denoising volumetric OCTA data sets. We showcase its imaging performance and clinical usability by presenting images of patients suffering from diabetic retinopathy.
CHOROIDAL NEOVASCULAR AREA AND VESSEL DENSITY COMPARISON BETWEEN TWO SWEPT-SOURCE OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY DEVICES. [2021]To compare choroidal neovascularization (CNV) area and vessel density (VD) measurements between two different swept-source optical coherence tomography angiography (SS-OCTA) devices.
Comparison of swept-source versus spectral-domain optical coherence tomography angiography for detection of macular neovascularization. [2022]To compare swept-source (SS) versus spectral-domain (SD) optical coherence tomography angiography (OCTA) for the detection of macular neovascularization (MNV).
Retinal capillary and choriocapillaris assessment using a beam modifier optical coherence tomography angiography module to increase lateral optical resolution. [2023]To assess a new optical coherence tomography angiography (OCTA) technology and its contribution to retinal vascularization and choriocapillaris (CC) exploration.
Optical coherence tomography angiography of optic nerve head and parafovea in multiple sclerosis. [2022]To investigate swept-source optical coherence tomography (OCT) angiography in the optic nerve head (ONH) and parafoveal regions in patients with multiple sclerosis (MS).
Assessing the Use of Incorrectly Scaled Optical Coherence Tomography Angiography Images in Peer-Reviewed Studies: A Systematic Review. [2021]Individual differences in axial length affect the lateral magnification of in vivo retinal images and as a result can affect the accuracy of quantitative measurements made from these images. As measurements from optical coherence tomography angiography (OCTA) images are becoming increasingly used in the diagnosis and monitoring of a wide range of diseases, evaluating which studies use correctly scaled images is crucial to their interpretation.
Reproducibility of macular and optic nerve head vessel density measurements by swept-source optical coherence tomography angiography. [2022]To assess the reproducibility of swept-source optical coherence tomography angiography (SS-OCTA) for macular and optic nerve head (ONH) vessel density (VD).
Choroidal Neovascularization Analyzed on Ultrahigh-Speed Swept-Source Optical Coherence Tomography Angiography Compared to Spectral-Domain Optical Coherence Tomography Angiography. [2022]To compare visualization of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) using an ultrahigh-speed swept-source (SS) optical coherence tomography angiography (OCTA) prototype vs a spectral-domain (SD) OCTA device.
Comparing imaging capabilities of spectral domain and swept source optical coherence tomography angiography in healthy subjects and central serous retinopathy. [2022]There are two forms of system implementation of optical coherence tomography angiography (OCTA) in ophthalmic imaging, i.e., spectral domain (SD-) and swept source OCTA (SS-OCTA). The purpose of this paper is to compare the SD-OCTA and SS-OCTA for elucidating structural and vascular features associated with central serous retinopathy (CSR), and to evaluate the effects of CSR on SD- and SS-OCTA's imaging capabilities.
[Optical coherence tomography angiography in neuronal diseases : Preliminary findings]. [2020]Optical coherence tomography angiography (OCTA) enables a noninvasive detailed imaging of retinal and choroidal vessels of the fundus. In neuronal diseases changes in retinal structures can be imaged and measured with OCT and OCTA.
75-degree non-mydriatic single-volume optical coherence tomographic angiography. [2021]Optical coherence tomography (OCT) and OCT angiography (OCTA) enable three-dimensional, high-resolution imaging of the eye. Yet, while they provide unprecedented structural and angiographic imaging detail, both have only limited fields of view in comparison to other imaging modalities like fundus photography. In this paper, we present a high-speed, high-sensitivity, swept source laser-based system that can acquire non-mydriatic 75-degree field of view OCT and OCTA images in a single complete scan without resorting to montaging techniques. The system uses an optimized scanning protocol and achieves capillary-level image quality. Such data may improve early detection of pathology and provide valuable information during disease monitoring.
Wide-field optical coherence tomography based microangiography for retinal imaging. [2022]Optical coherence tomography angiography (OCTA) allows for the evaluation of functional retinal vascular networks without a need for contrast dyes. For sophisticated monitoring and diagnosis of retinal diseases, OCTA capable of providing wide-field and high definition images of retinal vasculature in a single image is desirable. We report OCTA with motion tracking through an auxiliary real-time line scan ophthalmoscope that is clinically feasible to image functional retinal vasculature in patients, with a coverage of more than 60 degrees of retina while still maintaining high definition and resolution. We demonstrate six illustrative cases with unprecedented details of vascular involvement in retinal diseases. In each case, OCTA yields images of the normal and diseased microvasculature at all levels of the retina, with higher resolution than observed with fluorescein angiography. Wide-field OCTA technology will be an important next step in augmenting the utility of OCT technology in clinical practice.