Checking how well a new eye scanner measures the cornea
Tests how consistent an investigational eye measuring device is when measuring corneal thickness.
Key facts
- Who runs it
- Alcon Research
- Where
- Salt Lake City, United StatesSee the site
- Trial code
- Registry title
- UNITY DX Cornea Study
- Status
- Recruiting
- People taking part
- 110 people, planned
- Started
- 24 Sept 2026
- Expected to end
- Dec 2026
- Type of study
- Observational, 5 groups
- Treatments tested
- UNITY DX
- ANTERION
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with normal corneas, or with certain corneal conditions, to have their eyes measured with a new eye-scanning device. Groups include keratoconus, past laser vision correction, contact lens wear and dry eye.
- Age
- 22 years and older.
- Sex
- All sexes can join.
- Disease stage
- Normal corneas, or abnormal corneas as set by the protocol: keratoconus, past corneal laser vision correction, current and regular contact lens wear, or dry eye.
- Earlier treatment
- One group must have had corneal laser vision correction before.
Main reasons for not taking part
- Unable to hold the eye still, for example due to nystagmus (shaking eyes) or marked squint (strabismus).
- Any eye disease or condition that the study doctor thinks adds significant risk or could affect the results.
- Active eye infection or inflammation.
- Not able to attend all study visits.
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus
- Other protocol-specified exclusion criteria may apply
Where in United States
- The Eye Institute of UtahSalt Lake City, United StatesTaking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- 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.
Treatment: UNITY DX and 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.
Treatment: UNITY DX and 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.
Treatment: UNITY DX and 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.
Treatment: UNITY DX and 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.
Treatment: UNITY DX and ANTERION
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- UNITY DX Cornea Precision and Agreement Study
- Plain-language title
- Checking how well a new eye scanner measures the corneaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 12 November 2026