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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY030564 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Other | 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. |
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| Diabetics with and without Diabetic Retinopathy Only | Other | Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments. |
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| Hypertension Only | Other | 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. |
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| Diabetics w/ or w/o Diabetic Retinopathy & Hypertension | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swept-Source (SS) OCT Angiography | Device | Non-invasive, minimal risk, ocular imaging study |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Imaging | Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage | 5 years |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir H Kashani, MD, PhD | Contact | 410-502-2789 | akashan1@jhmi.edu | |
| Ana C Martinez, MPH | Contact | 410-502-2789 | acollaz5@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amir Kashani, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Spectral-Domain (SD) OCT Angiography | Device | Non-invasive, minimal risk, ocular imaging study |
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| Fundus Imaging | Device | Non-invasive, minimal risk, ocular imaging study |
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| Axial Length Measurement Device | Device | Non-invasive, minimal risk, ocular imaging study |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D012170 | Retinal Vein Occlusion |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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