Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types

Study Overview
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Brief Summary
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Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

Detailed Description
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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.

Official Title
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Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types

Conditions
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Retinal Vascular, Normal Eyes

Intervention / Treatment
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* Device: OCT Angiography
* Device: Color Fundus Photography
* Device: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Populations: Able and willing to undergo the test procedures, sign informed consent, and follow instructions. 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: Subjects unable to read or write Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging Subjects who cannot tolerate the imaging procedures Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Normal Eyes<br>OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology | Device: OCT Angiography<br>* 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.<br>* Other names: OCTA;Device: Color Fundus Photography<br>* Non-contact white light photography<br>* Other names: CFP;Device: Optical Coherence Tomography<br>* A non-contact test that uses light waves to take cross-sectional pictures of the retina<br>* Other names: OCT;|
| Experimental: Subjects with Pathology<br>OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology | Device: OCT Angiography<br>* 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.<br>* Other names: OCTA;Device: Color Fundus Photography<br>* Non-contact white light photography<br>* Other names: CFP;Device: Optical Coherence Tomography<br>* A non-contact test that uses light waves to take cross-sectional pictures of the retina<br>* Other names: OCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |