The Heidelberg Engineering BI US Evaluation Study

The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability

• BI Anterior Segment Mode (Device): Single eye measurement in Anterior Segment Mode
• BI Anterior Segment and IOL Biometry Mode (Device): Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode

Primary outcomes

• Percentage of successfully scanned biometry images of the eye [1 day]: Percentage of successfully scanned biometry images of the eyes per scan mode. Success is defined as agreement of the subjective assessment of the operator and the auto assessment of the device.
• Repeatabiltiy of specific parameters of the biometry images of the eye [1 day]: Repeatability of specific parameters stratified by different eye pathologies

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Age 18 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions

   At least one of the following:
3. Eyes with Normal Anterior Segment
4. Eyes with Cataract
5. Eyes without a Crystalline Lens
6. Eyes with Corneal Abnormality
7. Eyes with Anterior Segment Pathology

Exclusion Criteria:

1. Subjects unable to read or write
2. Active infection or inflammation in one or both eyes
3. Insufficient tear film or corneal reflex
4. Physical inability to be properly positioned at the study devices or eye exam equipment
5. Inability to fixate
6. Rigid contact lens wear during past 2 weeks
7. Soft lenses, in the study eye, if worn, should be removed at least one hour prior to the measurements *Note: Eyes with risk for acute angle closure glaucoma are excluded from the dilated portion of the study

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