The Heidelberg Engineering ANTERION Imaging Agreement Study

The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.

• ANTERION (Device): Biometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center

Primary outcomes

• Image quality [30 days]: Comparison of the B-Scan image quality between the ANTERION and the reference device
• Agreement in identification of abnormality [30 days]: Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device

Secondary outcomes

• Adverse Events [1 day]: Evaluate any adverse events found during the clinical study

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

Inclusion Criteria:

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment

B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:

* glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices
* corneal surgeries: corneal inlays and corneal transplants
* pterygium and corneal scar

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 Study
2. Physical inability to be properly positioned at the study devices or eye exam equipment
3. Contact lenses worn during imaging

• Mitchell Dul, Principal investigator, State University of New York College of Optometry