Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Conditions
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Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential, Retinal Vascular Disorder

Intervention / Treatment
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* Device: Swept-Source OCT Angiography
* Device: Spectral-Domain OCT Angiography
* Device: Fundus Imaging
* Device: Axial Length Measurement Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Controls<br>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<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SS-OCTA;Device: Spectral-Domain OCT Angiography<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SD_OCTA;Device: Fundus Imaging<br>* Non-invasive, minimal risk, ocular imaging study<br>Device: Axial Length Measurement Device<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: IOL Master;|
| Other: Diabetics with and without Diabetic Retinopathy Only<br>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<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SS-OCTA;Device: Spectral-Domain OCT Angiography<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SD_OCTA;Device: Fundus Imaging<br>* Non-invasive, minimal risk, ocular imaging study<br>Device: Axial Length Measurement Device<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: IOL Master;|
| Other: Hypertension Only<br>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<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SS-OCTA;Device: Spectral-Domain OCT Angiography<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SD_OCTA;Device: Fundus Imaging<br>* Non-invasive, minimal risk, ocular imaging study<br>Device: Axial Length Measurement Device<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: IOL Master;|
| Other: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension<br>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<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SS-OCTA;Device: Spectral-Domain OCT Angiography<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: SD_OCTA;Device: Fundus Imaging<br>* Non-invasive, minimal risk, ocular imaging study<br>Device: Axial Length Measurement Device<br>* Non-invasive, minimal risk, ocular imaging study<br>* Other names: IOL Master;|

What is the study measuring?
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Primary Outcome Measures

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