Agreement of Two OCT Biometers: A Pilot Study

NCT07782619 | Not Yet Recruiting FDA Device

• 1 other identifier: RA_A04555_007
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the measurements obtained with two different biometers, UNITY Dx and Anterion. In eye care, a biometer is a device that uses laser technology to take highly precise measurements of the eye's internal structures. It is most frequently used to help determine the exact power of the intraocular lens (IOL) needed before cataract removal.

Conditions

Anterior Segment of Eye; Axial Length; Biometrics Measurement

Keywords

Biometer

Outcome Measures

Primary Outcomes (1)

• Regression-Based Axial Length (R-AL)

  Regression-based Axial Length (R-AL) is the distance from the anterior surface of the cornea to the retina at the back of the eye, measured along the visual axis. R-AL will be measured by the device and reported in microns.

  Day 1

Study Arms (5)

Normal Corneas

This cohort will enroll subjects with normal corneas.

Device: UNITY DX; Device: ANTERION

Keratoconus

This cohort will enroll subjects with keratoconus.

Device: UNITY DX; Device: ANTERION

Prior Corneal Laser Vision Correction

This cohort will enroll subjects with prior corneal laser vision correction.

Device: UNITY DX; Device: ANTERION

Current and Habitual Contact Lens Wear

This cohort will enroll subjects with current and habitual contact lens wear.

Device: UNITY DX; Device: ANTERION

Dry Eye

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: 21 Years+
• Sex: all
• 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:

• Have healthy, clear corneas for the normal cohort;
• Have documented keratoconus for the keratoconus cohort;
• Have reported use of daily contact lens use for the contact lens cohort;
• Have documented dry eye, consisting of signs and symptoms for the dry eye cohort;
• Has had previous keratorefractive surgery for the post-refractive surgery cohort;
• Able to comprehend and sign the informed consent form.

You may not qualify if:

• Active ocular infection or inflammation;
• Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus);
• Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study result or may interfere significantly with the subject's participation in the study.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

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 20, 2026
• First Posted: August 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)