Retinal Vascular, Normal Eyes
Conditions
Brief summary
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
Detailed description
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.
Interventions
DEVICEOCT 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.
DEVICEColor Fundus Photography
Non-contact white light photography
DEVICEOptical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Sponsors
Heidelberg Engineering GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All Populations: 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
* All Populations: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed