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NCT Number: NCT07768735

UNITY DX Cornea Study

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

About this study

The study population will consist of male and female adult subjects with normal corneas (approximately 30 subjects), keratoconus (approximately 20 subjects), prior corneal laser vision correction (approximately 20 subjects), current and habitual contact lens wear (approximately 20 subjects), and dry eye (approximately 20 subjects). In this single visit study, measurements will be taken by 3 different operators using their own set of devices (configuration), UNITY DX and ANTERION. Each subject's participation is expected to last approximately 3 hours with a planned duration of exposure generally not longer than 10 minutes per device. Only one eye (designated as the study eye) will be enrolled per subject.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UNITY DX

Device

Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties

ANTERION

Device

Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties

Primary outcomes

  1. Mean corneal thickness

    Time frame: 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.

  2. Mean epithelial thickness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

UNITY DX Cornea Precision and Agreement Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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