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

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

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.

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