Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Study Details
Study Description
Brief Summary
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Detailed Description
The objectives of this study are:
1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.
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Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Subjects with Normal Eyes OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology |
Device: OCT Angiography
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.
Other Names:
Device: Color Fundus Photography
Non-contact white light photography
Other Names:
Device: Optical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Other Names:
|
Experimental: Subjects with Pathology OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology |
Device: OCT Angiography
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.
Other Names:
Device: Color Fundus Photography
Non-contact white light photography
Other Names:
Device: Optical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Image quality score [through study completion, an average of 1 day]
Graded 0-2 (0 = poor, 1 = average, 2 = good)
- Visibility of OCTA key anatomical vascular structures quality score [through study completion, an average of 1 day]
Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities
- Identification of vascular abnormalities on OCTA [through study completion, an average of 1 day]
Graded Yes, No, or Unable to Grade based on pre-specified abnormalities
- Adverse Events [through study completion, an average of 1 day]
All AEs
Eligibility Criteria
Criteria
Inclusion Criteria:
- All Populations:
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Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
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Age ≥ 22
- Normal Population:
- 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:
- 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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Subjects unable to read or write
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Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
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Subjects who cannot tolerate the imaging procedures
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Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Southeast Retina Center | Augusta | Georgia | United States | 30909 |
Sponsors and Collaborators
- Heidelberg Engineering GmbH
Investigators
- Principal Investigator: Dennis Marcus, MD, Southeast Retina Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S-2020-5