Normal EyesNCT06826599
Agreement and Precision Study of UNITY® DX and a Comparator Biometer
An observational study of Normal Eyes and Abnormal Eyes, run by Cylite Pty Ltd 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 the biometric measurements 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
- Normal Eyes, Abnormal Eyes
- What is being tested?
- Investigational Biometer and IOLMaster 700 Biometer
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2025to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Institution Review Board approved Informed Consent form.
- Willing and able to attend all scheduled study visits as required by the protocol.
- Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.
Who cannot join
- Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
- Any ocular disease and/or condition that, in the investigator's clinical judgment, 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.
- Rigid or contact lens wear during the previous two weeks prior to Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthEast Eye Research Associates LLC
Woburn, Massachusetts, 01801
About this 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 the biometric measurements will be evaluated.
Read the detailed description
This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.
- Conditions
- Normal Eyes, Abnormal Eyes
- Being tested
- Investigational Biometer, IOLMaster 700 Biometer
- Keywords
- Biometric measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational BiometerDevice
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters
IOLMaster 700 BiometerDevice
Commercially available non-contact instrument used to capture optical biometry measurements
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Normal Eyes | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans Receives: Device: Investigational Biometer; Device: IOLMaster 700 Biometer | |
| Group 2 - Eyes with cataracts | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans Receives: Device: Investigational Biometer; Device: IOLMaster 700 Biometer | |
| Group 3 - Eyes with significant refractive errors | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans Receives: Device: Investigational Biometer; Device: IOLMaster 700 Biometer | |
| Group 4 - Eyes with abnormal corneal topography | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans Receives: Device: Investigational Biometer; Device: IOLMaster 700 Biometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal thickness (CCT)
Central corneal thickness will be measured in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Measured: Day 1
Lens thickness (LT)
Lens thickness will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Measured: Day 1
Anterior chamber depth (regression) (ACD-R)
Anterior chamber depth (the physical length from the anterior cornea to the anterior lens) will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Measured: Day 1
Axial length (regression) (AL-R)
Axial length (the distance between the back and front of the eye) will be measured in millimeters and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Measured: Day 1
Secondary outcomes (2)
Anterior Chamber Depth Sum of Segments (ACD-SoS)
ACD-SoS is calculated by calculating the individual corneal thickness and aqueous depth segments, applying the known refractive indices for each segment, and summing the resultant measurement of each segment. ACD-SoS will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, and reproducibility methods.
Measured: Day 1
Axial Length Sum of Segments (AL-SoS)
AL-SoS is calculated by calculating the individual corneal thickness, aqueous depth, lens thickness and vitreous length segments, applying the known refractive indices for each segment, and summing the resultant measurement of each segment. AL-SoS will be measured in millimeters and analyzed using using Bland-Altman Limits of Agreement, repeatability, and reproducibility methods.
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 posted14 Feb 2025
- Study start18 Jan 2025
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal EyesStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cylite Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnold Ouyang, PhD, Study director, Cylite Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826599
- Sponsor's protocol ID
- CYC-CL-SOP-004
- Status last verified
- Aug 2025
- First submitted
- 4 Feb 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement and Precision Study of UNITY® DX and a Comparator Biometer
- ClinicalTrials.gov ID
- NCT06826599
- Acronym / sponsor ID
- CYC-CL-SOP-004
- Conditions
- Normal Eyes, Abnormal Eyes
- Keywords
- Biometric measurements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cylite Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 14 Feb 2025 (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 the biometric measurements will be evaluated.
Detailed description
This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Normal Eyes | – | Device: Investigational Biometer, Device: IOLMaster 700 BiometerThe eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
| Group 2 - Eyes with cataracts | – | Device: Investigational Biometer, Device: IOLMaster 700 BiometerThe eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
| Group 3 - Eyes with significant refractive errors | – | Device: Investigational Biometer, Device: IOLMaster 700 BiometerThe eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
| Group 4 - Eyes with abnormal corneal topography | – | Device: Investigational Biometer, Device: IOLMaster 700 BiometerThe eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
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 (3 listed)
- Able to understand and sign an Institution Review Board approved Informed Consent form.
- Willing and able to attend all scheduled study visits as required by the protocol.
- Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.
Key exclusion criteria (4 listed)
- Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
- Any ocular disease and/or condition that, in the investigator's clinical judgment, 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.
- Rigid or contact lens wear during the previous two weeks prior to Screening.
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 |
|---|---|---|
| Investigational BiometerInvestigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters | Device | Group 1 - Normal Eyes, Group 2 - Eyes with cataracts, Group 3 - Eyes with significant refractive errors, Group 4 - Eyes with abnormal corneal topography |
| IOLMaster 700 BiometerCommercially available non-contact instrument used to capture optical biometry measurements | Device | Group 1 - Normal Eyes, Group 2 - Eyes with cataracts, Group 3 - Eyes with significant refractive errors, Group 4 - Eyes with abnormal corneal topography |
Primary outcome
Central corneal thickness (CCT)
Time frame: Day 1
Central corneal thickness will be measured in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Lens thickness (LT)
Time frame: Day 1
Lens thickness will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Anterior chamber depth (regression) (ACD-R)
Time frame: Day 1
Anterior chamber depth (the physical length from the anterior cornea to the anterior lens) will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Axial length (regression) (AL-R)
Time frame: Day 1
Axial length (the distance between the back and front of the eye) will be measured in millimeters and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
2 secondary outcomes
Anterior Chamber Depth Sum of Segments (ACD-SoS)
Time frame: Day 1
Axial Length Sum of Segments (AL-SoS)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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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. This study is not recruiting at the moment.
Arnold Ouyang, PhD study director
Cylite Pty Ltd
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 Normal Eyes and Abnormal Eyes, run by Cylite Pty Ltd 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 3 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: finished, as of the sponsor's last update on 5 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central corneal thickness (CCT) (time frame: Day 1). The study lists 4 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 5 Aug 2025.