Thinking of joining a study?

Register your interest

NCT04505618 | RECRUITING | Diabetic Retinopathy


Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
Sponsor:

Johns Hopkins University

Brief 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.

Condition or disease

Diabetic Retinopathy

Retinal Vein Occlusion

Hypertension,Essential

Retinal Vascular Disorder

Intervention/treatment

Swept-Source (SS) OCT Angiography

Spectral-Domain (SD) OCT Angiography

Fundus Imaging

Axial Length Measurement Device

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 1050 participants
Masking : SINGLE
Primary Purpose : SCREENING
Official Title : Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
Actual Study Start Date : 2019-10-01
Estimated Primary Completion Date : 2026-06-01
Estimated Study Completion Date : 2026-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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

Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Location Details

NCT04505618


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Maryland

Wilmer Eye Institute

Baltimore, Maryland, United States, 21287

Loading...