UNITY DX Cornea Study

UNITY DX Cornea Precision and Agreement 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tomography
• Intervention / Treatment: Device: UNITY DX; Device: ANTERION

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Alcon Call Center; Phone Number: 1-888-451-3937; Email: alcon.medinfo@alcon.com

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • The Eye Institute of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties; Device: ANTERION; Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties; Device: ANTERION; Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties; Device: ANTERION; 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; 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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties; Device: ANTERION; Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties; Device: ANTERION; Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Dry eye; Keratoconus; Refractive surgery; Laser vision correction; Corneal surgery; Biometric parameters
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Keratoconus
• Other Study ID Numbers: CTK378-C003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes