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Clinical Trials/NCT04505618
NCT04505618
Recruiting
Not Applicable

Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Johns Hopkins University1 site in 1 country1,050 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Swept-Source (SS) OCT Angiography
Conditions
Diabetic Retinopathy
Sponsor
Johns Hopkins University
Enrollment
1050
Locations
1
Primary Endpoint
Correlation of Imaging
Status
Recruiting
Last Updated
last month

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
September 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion 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

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

Arms & Interventions

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.

Intervention: Swept-Source (SS) OCT Angiography

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.

Intervention: Spectral-Domain (SD) OCT Angiography

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.

Intervention: Fundus Imaging

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.

Intervention: Axial Length Measurement Device

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.

Intervention: Swept-Source (SS) OCT Angiography

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.

Intervention: Spectral-Domain (SD) OCT Angiography

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.

Intervention: Fundus Imaging

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.

Intervention: Axial Length Measurement Device

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.

Intervention: Swept-Source (SS) OCT Angiography

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.

Intervention: Spectral-Domain (SD) OCT Angiography

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.

Intervention: Fundus Imaging

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.

Intervention: Axial Length Measurement Device

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.

Intervention: Swept-Source (SS) OCT Angiography

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.

Intervention: Spectral-Domain (SD) OCT Angiography

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.

Intervention: Fundus Imaging

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.

Intervention: Axial Length Measurement Device

Outcomes

Primary Outcomes

Correlation of Imaging

Time Frame: 5 years

Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage

Study Sites (1)

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