Clinical trial Recruiting at 1 site Observational Ages 22 and up

Unity DX Cornea Study

Official title: UNITY DX Cornea Precision and Agreement Study

Run by Alcon Research · NCT07768735 · Data updated 2026-11-12

This study tests a new biometer to see how well it measures corneal and epithelial thickness compared with existing devices in adults with normal, abnormal, or post-surgery eyes.

Quick facts

Study typeObservational
Ages22 Years and up
SexAll
Enrollment110 (estimated)
SponsorAlcon Research
Industry-sponsored
Locations1 site (Salt Lake City, Utah)
StatusRecruiting
StartedSeptember 24, 2026
Main results expectedNovember 2026
Study endsNovember 2026
Registry record updatedOctober 27, 2026
Trial IDNCT07768735 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with normal or abnormal corneas, including keratoconus, prior corneal laser surgery, contact lens wear, or dry eye, who can consent and complete the study protocol.

Probably not a fit

Participants with conditions preventing fixation or with active ocular infection or significant inflammation may not benefit from the measurements collected in this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the measurement performance of an investigational biometer by taking multiple measurements of the eye across several participant groups. Three different operators will use their own device configurations (UNITY DX and ANTERION) to assess agreement, repeatability, and reproducibility of corneal and epithelial thickness maps in a single visit. Approximately 110 adults, including normal corneas, keratoconus, prior laser vision correction, contact lens wear, and dry eye, will be enrolled. Each participant contributes data from one designated study eye, with exposure times per device generally under 10 minutes. The study aims to establish whether the new device provides consistent and reliable biometric measurements across diverse corneal conditions.

Why it matters

Potential benefit: If successful, the new biometer could offer reliable, repeatable corneal measurements to support better diagnosis and treatment planning in refractive and corneal care.

How similar studies have gone: Previous studies have demonstrated the value of multi-device biometric measurements, and this study extends that approach to a new biometer in diverse corneal conditions.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Agreement of Two OCT Biometers: A Pilot Study

    This pilot study tests whether two OCT biometers, UNITY Dx and Anterion, produce comparable eye measurements for adults across several eye-conditions to help guide IOL power decisions.

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  • Eye drop for redness in adults: relief with a new ophthalmic solution

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    Recruiting at 2 sites Phase 3 Alcon Research · Los Angeles, California and 8 other locations · NCT07531043

  • Clareon TruPlus IOLs in Bilateral Cataract Surgery

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    Recruiting at 5 sites Alcon Research · Phoenix, Arizona and 4 other locations · NCT07502456

  • Comparing surgery times for UNITY® VCS and CONSTELLATION® Vision System

    This study will see if the UNITY® VCS or the CONSTELLATION® Vision System leads to shorter combined cataract and vitrectomy (phacovitrectomy) surgery times for adults planned for 25‑gauge procedures.

    Recruiting Alcon Research · Manchester · NCT07228091

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.