UNITY DX Cornea Study

NCT07768735 | Not Yet Recruiting FDA Device

• 1 other identifier: CTK378-C003
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mean corneal thickness

  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.

  Day 1

• Mean epithelial thickness

  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.

  Day 1

Study Arms (5)

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.

Device: UNITY DX; Device: ANTERION

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.

Device: UNITY DX; Device: ANTERION

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.

Device: UNITY DX; Device: ANTERION

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.

Device: UNITY DX; Device: ANTERION

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.

Device: UNITY DX; Device: ANTERION

Interventions

UNITY DX DEVICE

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

Current and Habitual Contact Lens Wear; Dry Eye; Keratoconus; Normal Corneas; Prior Corneal Laser Vision Correction

ANTERION DEVICE

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

Current and Habitual Contact Lens Wear; Dry Eye; Keratoconus; Normal Corneas; Prior Corneal Laser Vision Correction

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohorts will be selected from approximately one investigative site located in the United States.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Keratoconus; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Clinical Trial Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)