Anterior Segment of EyeNCT07782619
Agreement of Two OCT Biometers: A Pilot Study
An observational study of Anterior Segment of Eye and Axial Length, run by Alcon Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anterior Segment of Eye, Axial Length, Biometrics Measurement
- What is being tested?
- UNITY DX and ANTERION
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to Jan 2027
- 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 21 years and older
- All sexes
- 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
- 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.
Who cannot join
- 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.
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
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.
Read the detailed description
The study population will consist of male and female adult subjects with a normal cornea (up to 10 subjects), keratoconus (up to 10 subjects), prior corneal laser vision correction (up to 10 subjects), current and habitual contact lens wear (up to 10 subjects), or dry eye (up to 10 subjects). In this single visit study, subjects will have data collected on one eye (unilateral) only. If both eyes meet the entry criteria, the right eye will be designated as the study eye.
- Being tested
- UNITY DX, ANTERION
- Keywords
- Biometer
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 | This cohort will enroll subjects with normal corneas. Receives: Device: UNITY DX; Device: ANTERION | |
| Keratoconus | This cohort will enroll subjects with keratoconus. Receives: Device: UNITY DX; Device: ANTERION | |
| Prior Corneal Laser Vision Correction | This cohort will enroll subjects with prior corneal laser vision correction. Receives: Device: UNITY DX; Device: ANTERION | |
| Current and Habitual Contact Lens Wear | This cohort will enroll subjects with current and habitual contact lens wear. Receives: Device: UNITY DX; Device: ANTERION | |
| Dry Eye | 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.
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.
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 posted24 Aug 2026
- Study start17 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Segment of EyeStudies 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
- 50 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
- NCT07782619
- Sponsor's protocol ID
- RA_A04555_007
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement of Two OCT Biometers: A Pilot Study
- ClinicalTrials.gov ID
- NCT07782619
- Acronym / sponsor ID
- RA_A04555_007
- Keywords
- Biometer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 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 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.
Detailed description
The study population will consist of male and female adult subjects with a normal cornea (up to 10 subjects), keratoconus (up to 10 subjects), prior corneal laser vision correction (up to 10 subjects), current and habitual contact lens wear (up to 10 subjects), or dry eye (up to 10 subjects). In this single visit study, subjects will have data collected on one eye (unilateral) only. If both eyes meet the entry criteria, the right eye will be designated as the study eye.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal Corneas | – | Device: UNITY DX, Device: ANTERIONThis cohort will enroll subjects with normal corneas. |
| Keratoconus | – | Device: UNITY DX, Device: ANTERIONThis cohort will enroll subjects with keratoconus. |
| Prior Corneal Laser Vision Correction | – | Device: UNITY DX, Device: ANTERIONThis cohort will enroll subjects with prior corneal laser vision correction. |
| Current and Habitual Contact Lens Wear | – | Device: UNITY DX, Device: ANTERIONThis cohort will enroll subjects with current and habitual contact lens wear. |
| Dry Eye | – | Device: UNITY DX, Device: ANTERIONThis cohort will enroll subjects with dry eye. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cohorts will be selected from approximately one investigative site located in the United States.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
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
Regression-Based Axial Length (R-AL)
Time frame: Day 1
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.
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 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Anterior Segment of Eye
RecruitingObservational study
PANDA-ASOCT: Paediatric Anterior Uveitis Detection With Automated Image Analysis Using ASOCT
Uveitis
RecruitingObservational study
Multimodal Deep Learning Model for Multi-task Diagnosis and Triage Suggestions of Ophthalmic Diseases
Anterior Segment Diseases
RecruitingObservational study
National Cohort on Congenital Defects of the Eye
Anophthalmia, Microphthalmia
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingObservational study
Acute Ocular Effects of Cigarette Smoking
Smoking ( Cigarette), Cornea
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 Anterior Segment of Eye and Axial Length, 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 6 inclusion and 3 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 2 Sep 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?
Regression-Based Axial Length (R-AL) (time frame: Day 1). 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 2 Sep 2026.