Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease (OCTA-RVD)

August 14, 2023 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to 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.

Subjects will be identified from healthy subjects (seen for screening eye exams) and diseased subjects undergoing standard-of-care treatment or screening at eye clinic locations. The study population will include subjects with retinal vascular disease including but not limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes.

The study methods will include retrospective review and collection of clinically approved imaging data that is obtained through standard-of-care methods for subjects who meet inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to participate in a prospective study by each clinical study site.

The study end-points include the correlation of diagnostic imaging findings from OCT based images with fundus photographs, clinical disease stage and visual acuity.

Study Type

Interventional

Enrollment (Estimated)

1050

Phase

  • Not Applicable

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 Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Wilmer Eye Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amir H Kashani, MD, PhD

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

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Exclusion Criteria:

  • Both subjects with diseases and controls:
  • Children (age<18)
  • Pregnant females
  • Developmentally delayed subjects
  • Subjects unable to provide informed consent
  • Inability to cooperate with tests and study instructions
  • Images with motion artifact or signal strength < 7
  • History of glaucoma
  • History of age-related macular degeneration
  • History of any visually significant eye disease
  • History of proliferative diabetic retinopathy
  • History of any inflammatory disease
  • History of heart disease
  • History of thyroid disease.
  • Additional criteria for controls:
  • History of any type of Diabetes Mellitus
  • History of any type of Hypertension

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Controls
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.
Device: Swept-Source OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SS-OCTA
Device: Spectral-Domain OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SD_OCTA
Device: Fundus Imaging
Non-invasive, minimal risk, ocular imaging study
Device: Axial Length Measurement Device
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • IOL Master
Other: Diabetics with and without Diabetic Retinopathy Only
Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Device: Swept-Source OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SS-OCTA
Device: Spectral-Domain OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SD_OCTA
Device: Fundus Imaging
Non-invasive, minimal risk, ocular imaging study
Device: Axial Length Measurement Device
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • IOL Master
Other: Hypertension Only
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.
Device: Swept-Source OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SS-OCTA
Device: Spectral-Domain OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SD_OCTA
Device: Fundus Imaging
Non-invasive, minimal risk, ocular imaging study
Device: Axial Length Measurement Device
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • IOL Master
Other: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
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.
Device: Swept-Source OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SS-OCTA
Device: Spectral-Domain OCT Angiography
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • SD_OCTA
Device: Fundus Imaging
Non-invasive, minimal risk, ocular imaging study
Device: Axial Length Measurement Device
Non-invasive, minimal risk, ocular imaging study
Other Names:
  • IOL Master

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Imaging
Time Frame: 5 years
Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage
5 years

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Collaborators

National Eye Institute (NEI)

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 (Actual)

October 1, 2019

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00276904
  • R01EY030564 (U.S. NIH Grant/Contract)

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.

Yes

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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