UNITY DX: Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
ANTERION: Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Study summary
The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of corneal and epithelial thickness maps will be evaluated.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
Accepted
Key Inclusion Criteria:
* Able to understand and sign an Institutional Review Board approved informed consent form.
* Willing and able to attend all scheduled study visits as required per protocol.
* Identified by the investigator as having normal corneas or abnormal corneas per protocol-specified criteria.
* Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
* Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus.
* Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
* Active ocular infection or inflammation.
* Other protocol-specified exclusion criteria may apply.
Primary outcome measure(s)
Mean corneal thickness — Day 1 Corneal thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
Mean epithelial thickness — Day 1 Epithelial thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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