Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
NCT ID: NCT04604002
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
86 participants
OBSERVATIONAL
2020-10-15
2022-01-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with Normal Eyes
OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology
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.
Color Fundus Photography
Non-contact white light photography
Optical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Subjects with Pathology
OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology
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.
Color Fundus Photography
Non-contact white light photography
Optical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Interventions
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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.
Color Fundus Photography
Non-contact white light photography
Optical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
2. Age ≥ 22
* 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
1. Subjects unable to read or write
2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
3. Subjects who cannot tolerate the imaging procedures
4. Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image
22 Years
ALL
Yes
Sponsors
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Heidelberg Engineering GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Marcus, MD
Role: PRINCIPAL_INVESTIGATOR
Southeast Retina Center
Locations
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Southeast Retina Center
Augusta, Georgia, United States
Countries
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Other Identifiers
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S-2020-5
Identifier Type: -
Identifier Source: org_study_id
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