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 type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | September 24, 2026 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07768735 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
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.