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

Study Overview
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Brief Summary
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This is a prospective clinical study conducted at one clinical site in the United States.

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

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

Conditions
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Retinal Disease, Healthy Eyes

Intervention / Treatment
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* Device: SPECTRALIS
* Device: SPECTRALIS with Flex Module


Participation Criteria
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Eligibility Criteria
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Adult Normal Eyes Population (AN) Inclusion Criteria for AN Population Age ≥ 22 years Able and willing to undergo the test procedures, sign informed consent, and follow instructions. Physically able to be positioned in all required imaging positions (upright at chinrest and supine). Able to fixate. Best corrected visual acuity ≥ 20/40 in both eyes. Exclusion Criteria for AN Population Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging. Subjects who cannot tolerate the imaging procedures. Clinically significant ocular disease in either eye as determined by an Investigator. 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 Age ≥ 22 years Able and willing to undergo the test procedures, sign informed consent, and follow instructions. Physically able to be positioned in all required imaging positions (upright at chinrest and supine). Able to fixate. Eye with a structural and vascular posterior segment abnormality due to ocular disease and/or trauma. Exclusion Criteria for AD Population Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging. Subjects who cannot tolerate the imaging procedures.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult Normal Eyes<br>see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA | Device: SPECTRALIS<br>* ophthalmic imaging device with head and chinrest<br>* Other names: SPECTRALIS HRA+OCT (and variants) with OCT Angiography Module;Device: SPECTRALIS with Flex Module<br>* ophthalmic imaging device on mobile instrumentation stand<br>* Other names: SPECTRALIS HRA+OCT (and variants) with Flex Module;|
| Adult Pathology Eyes<br>see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA | Device: SPECTRALIS<br>* ophthalmic imaging device with head and chinrest<br>* Other names: SPECTRALIS HRA+OCT (and variants) with OCT Angiography Module;Device: SPECTRALIS with Flex Module<br>* ophthalmic imaging device on mobile instrumentation stand<br>* Other names: SPECTRALIS HRA+OCT (and variants) with Flex Module;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | All AEs | through study completion, average of 1 day |