Recruiting

Observational Study

Sponsor:

Alcon Research

Code:

NCT07768735

Conditions

Tomography

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

UNITY DX

ANTERION

Study Details

Brief 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.

Conditions

Tomography

Study ID

NCT07768735

Start date

Sep 24, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

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.

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal Corneas

The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with normal corneas.

Keratoconus

The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with keratoconus.

Prior Corneal Laser Vision Correction

The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with prior corneal laser vision correction.

Current and Habitual Contact Lens Wear

The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with current and habitual contact lens wear.

Dry Eye

The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with dry eye.

Interventions

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

Primary outcome measure

  • Mean corneal thickness [ Time Frame: Day 1 ]
  • Mean epithelial thickness [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Alcon Call Center

1-888-451-3937alcon.medinfo@alcon.com

Locations

The Eye Institute of Utah

Recruiting

Salt Lake City, Utah, United States, 84107

More Information

Sponsor

Alcon Research

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Corneal surgery
  • Refractive surgery
  • Biometric parameters
  • Keratoconus
  • Dry eye
  • Laser vision correction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Alcon Research on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.