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

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

• SPECTRALIS (Device), also known as SPECTRALIS HRA+OCT (and variants) with OCT Angiography Module: ophthalmic imaging device with head and chinrest
• SPECTRALIS with Flex Module (Device), also known as SPECTRALIS HRA+OCT (and variants) with Flex Module: ophthalmic imaging device on mobile instrumentation stand

Primary outcomes

• The image quality grade of the acquired images as determined by an independent reading center [through study completion, average of 1 day]: OCT, OCTA and IR cSLO - graded Good (2)/Average (1)/Poor (0)
• Agreement in identification of abnormalities of the acquired Standard OCT images between the devices [through study completion, average of 1 day]: based on pre-specified abnormalities
• Agreement in identification of abnormalities of the acquired OCTA images between the devices [through study completion, average of 1 day]: based on pre-specified abnormalities

Secondary outcomes

• Adverse events [through study completion, average of 1 day]: All AEs

Sex: All, ages: 22 Years to any, accepts healthy volunteers

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.

• Lejla Vajzovic, MD, Principal investigator, Duke University