Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position

Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position

This is a prospective clinical study conducted at one clinical site in the United States.

The conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.

Adult Normal Eyes Population (AN)

Inclusion Criteria for AN Population

1. Age ≥ 22 years
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
3. Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
4. Able to fixate.
5. Best corrected visual acuity ≥ 20/40 in both eyes.

Exclusion Criteria for AN Population

1. Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
2. Subjects who cannot tolerate the imaging procedures.
3. Clinically significant ocular disease in either eye as determined by an Investigator.
4. Ocular surgical intervention (except for refractive laser surgery or cataract surgery) in either eye.

Adult Posterior Segment Abnormality Eye Population (AD)

Inclusion Criteria for AD Population

1. Age ≥ 22 years
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
3. Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
4. Able to fixate.
5. Eye with a structural and vascular posterior segment abnormality due to ocular disease and/or trauma.

Exclusion Criteria for AD Population

1. Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
2. Subjects who cannot tolerate the imaging procedures.