Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
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.
Investigators
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