Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Swept-Source (SS) OCT Angiography, Spectral-Domain (SD) OCT Angiography, Fundus Imaging, Axial Length Measurement Device.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential, Retinal Vascular Disorder. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Swept-Source (SS) OCT Angiography
Non-invasive, minimal risk, ocular imaging study - Device Spectral-Domain (SD) OCT Angiography
Non-invasive, minimal risk, ocular imaging study - Device Fundus Imaging
Non-invasive, minimal risk, ocular imaging study - Device Axial Length Measurement Device
Non-invasive, minimal risk, ocular imaging study
Primary outcome measures
- Correlation of Imaging [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
United States · 1 center
- Wilmer Eye Institute — Baltimore
Identifiers
NCT: NCT04505618 · IRB00276904 · R01EY030564