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Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
The objectives of this study are:
1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.
2. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.
3. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Normal Eyes | OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology |
| |
| Subjects with Pathology | OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT Angiography | Device | OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes. |
| Measure | Description | Time Frame |
|---|---|---|
| Image quality score | Graded 0-2 (0 = poor, 1 = average, 2 = good) | through study completion, an average of 1 day |
| Visibility of OCTA key anatomical vascular structures quality score | Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities | through study completion, an average of 1 day |
| Identification of vascular abnormalities on OCTA | Graded Yes, No, or Unable to Grade based on pre-specified abnormalities | through study completion, an average of 1 day |
| Adverse Events | All AEs | through study completion, an average of 1 day |
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Inclusion Criteria:
All Populations:
Normal Population:
3. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)
Pathology Population:
3. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye
Exclusion Criteria:
All Populations:
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Adults with Healthy Eyes and Adults with Eyes with retinal vascular pathology
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Marcus, MD | Southeast Retina Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Color Fundus Photography | Device | Non-contact white light photography |
|
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| Optical Coherence Tomography | Device | A non-contact test that uses light waves to take cross-sectional pictures of the retina |
|
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |