1050 Participants Needed

OCT Angiography for Retinopathy

(OCTA-RVD Trial)

Recruiting at 1 trial location
AH
AC
Overseen ByAna C Martinez, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Is 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.12345

How 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.678910

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.36111213

Who Is on the Research Team?

AK

Amir Kashani, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • Axial Length Measurement Device
  • Fundus Imaging
  • Spectral-Domain OCT Angiography
  • Swept-Source OCT Angiography
Trial Overview 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.
How Is the Trial Designed?
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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

Published Research Related to This Trial

Using advanced imaging techniques like spectral domain (SD) and swept source (SS) optical coherence tomography angiography (OCTA), researchers successfully visualized choroidal vessels in all eyes, indicating the effectiveness of these methods for anatomical assessment.
Choroidal blood flow detection was primarily observed in eyes with retinal pigment epithelium (RPE) atrophy, suggesting that intact RPE limits the ability to assess deeper choroidal blood flow, which could impact the evaluation of ocular disorders.
Imaging the Deep Choroidal Vasculature Using Spectral Domain and Swept Source Optical Coherence Tomography Angiography.Diaz, JD., Wang, JC., Oellers, P., et al.[2022]
A new high-speed swept-source OCT system can capture ultra-wide fields of view up to 90 degrees, significantly improving the resolution and detail of retinal imaging compared to current OCTA devices.
The introduction of a deep learning algorithm for denoising OCTA data enhances the quality of images, making it particularly useful for diagnosing conditions like diabetic retinopathy.
Ultra-Widefield OCT Angiography.Niederleithner, M., de Sisternes, L., Stino, H., et al.[2023]
Both the Zeiss PLEX Elite 9000 and Topcon DRI OCT Triton SS-OCTA devices showed excellent agreement in measuring the area of choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration, indicating they can be reliably used interchangeably for this purpose.
However, vessel density (VD) measurements were less consistent, with poor agreement observed between different image sizes and between the two devices, suggesting that for accurate longitudinal VD analysis, it is preferable to use the same device consistently.
CHOROIDAL NEOVASCULAR AREA AND VESSEL DENSITY COMPARISON BETWEEN TWO SWEPT-SOURCE OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY DEVICES.Ohayon, A., Sacconi, R., Semoun, O., et al.[2021]

Citations

Imaging the Deep Choroidal Vasculature Using Spectral Domain and Swept Source Optical Coherence Tomography Angiography. [2022]
Ultra-Widefield OCT Angiography. [2023]
CHOROIDAL NEOVASCULAR AREA AND VESSEL DENSITY COMPARISON BETWEEN TWO SWEPT-SOURCE OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY DEVICES. [2021]
Comparison of swept-source versus spectral-domain optical coherence tomography angiography for detection of macular neovascularization. [2022]
Retinal capillary and choriocapillaris assessment using a beam modifier optical coherence tomography angiography module to increase lateral optical resolution. [2023]
Optical coherence tomography angiography of optic nerve head and parafovea in multiple sclerosis. [2022]
Assessing the Use of Incorrectly Scaled Optical Coherence Tomography Angiography Images in Peer-Reviewed Studies: A Systematic Review. [2021]
Reproducibility of macular and optic nerve head vessel density measurements by swept-source optical coherence tomography angiography. [2022]
Choroidal Neovascularization Analyzed on Ultrahigh-Speed Swept-Source Optical Coherence Tomography Angiography Compared to Spectral-Domain Optical Coherence Tomography Angiography. [2022]
Comparing imaging capabilities of spectral domain and swept source optical coherence tomography angiography in healthy subjects and central serous retinopathy. [2022]
[Optical coherence tomography angiography in neuronal diseases : Preliminary findings]. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
75-degree non-mydriatic single-volume optical coherence tomographic angiography. [2021]
Wide-field optical coherence tomography based microangiography for retinal imaging. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security