TomographyNCT07768735
UNITY DX Cornea Study
An observational study of Tomography, run by Alcon Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tomography
- What is being tested?
- UNITY DX and ANTERION
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohorts will be selected from approximately one investigative site located in the United States.
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Eye Institute of Utah
Salt Lake City, Utah, 84107
About this study
Official title: 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.
Read the 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.
- Conditions
- Tomography
- Being tested
- UNITY DX, ANTERION
- Keywords
- Corneal surgery, Refractive surgery, Biometric parameters, Keratoconus, Dry eye, Laser vision correction
- Medical subject headings
- Keratoconus, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNITY DXDevice
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
ANTERIONDevice
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: UNITY DX; Device: 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. Receives: Device: UNITY DX; Device: 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. Receives: Device: UNITY DX; Device: 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. Receives: Device: UNITY DX; Device: 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. Receives: Device: UNITY DX; Device: ANTERION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start24 Sep 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TomographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768735
- Sponsor's protocol ID
- CTK378-C003
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNITY DX Cornea Precision and Agreement Study
- ClinicalTrials.gov ID
- NCT07768735
- Acronym / sponsor ID
- CTK378-C003
- Conditions
- Tomography
- Keywords
- Corneal surgery, Refractive surgery, Biometric parameters, Keratoconus, Dry eye, Laser vision correction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal Corneas | – | Device: UNITY DX, Device: ANTERIONThe eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with normal corneas. |
| Keratoconus | – | Device: UNITY DX, Device: ANTERIONThe eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with keratoconus. |
| Prior Corneal Laser Vision Correction | – | Device: UNITY DX, Device: ANTERIONThe 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. |
| Current and Habitual Contact Lens Wear | – | Device: UNITY DX, Device: ANTERIONThe 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. |
| Dry Eye | – | Device: UNITY DX, Device: ANTERIONThe eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with dry eye. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohorts will be selected from approximately one investigative site located in the United States.
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNITY DXInvestigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties | Device | Current and Habitual Contact Lens Wear, Dry Eye, Keratoconus, Normal Corneas, Prior Corneal Laser Vision Correction |
| ANTERIONCommercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties | Device | Current and Habitual Contact Lens Wear, Dry Eye, Keratoconus, Normal Corneas, Prior Corneal Laser Vision Correction |
Primary outcome
Mean corneal thickness
Time frame: Day 1
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.
Mean epithelial thickness
Time frame: Day 1
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Lead, Surgical study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tomography, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alcon Call Center (1-888-451-3937, alcon.medinfo@alcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean corneal thickness (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.