Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Last updated: August 6, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Diabetic Retinopathy

High Blood Pressure (Hypertension - Pediatric)

Treatment

Swept-Source OCT Angiography

Spectral-Domain OCT Angiography

Spectral-Domain (SD) OCT Angiography

Clinical Study ID

NCT04505618
IRB00276904
R01EY030564
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 1050
Treatment Group(s): 6
Primary Treatment: Swept-Source OCT Angiography
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
September 01, 2025

Study 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 Optical Coherence Tomography (OCT) based images with fundus photographs, clinical disease stage and visual acuity.

Connect with a study center

  • USC Roski Eye Institute

    Los Angeles, California 90033
    United States

    Site Not Available

  • Wilmer Eye Institute

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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