Eyes With Normal Anterior SegmentNCT06397976
The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
An observational study of Eyes With Normal Anterior Segment and Eyes With Abnormal Anterior Segment, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version) Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eyes With Normal Anterior Segment, Eyes With Abnormal Anterior Segment
- What is being tested?
- ANTERION investigational
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 5 Nov 2024
- 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: Eyes with normal and eyes with abnormal anterior segment population
Who may be able to join
- Age 22 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- Eye(s) with normal anterior segment
- Age 22 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)
Who cannot join
- Active infection or inflammation in the study eye
- Insufficient tear film or corneal reflex
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Rigid contact lens wear 2 weeks prior to imaging
- Soft lenses worn within one hour prior to imaging
- Cataract grade ≥1.5
Show all 11Show fewer
- Active infection or inflammation in the study eye
- Insufficient tear film or corneal reflex
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Rigid contact lens wear 2 weeks prior to imaging
- Soft lenses worn within one hour prior to imaging
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)
- Being tested
- ANTERION investigational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTERION investigationalDevice
Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)
| Study group | Role | What they receive |
|---|---|---|
| Eyes with normal anterior segment | Not described Receives: Device: ANTERION investigational | |
| Eyes with abnormal anterior segment | Not described Receives: Device: ANTERION investigational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Cornea Thickness
Reproducibility and repeatability of Central Cornea Thickness of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Thinnest Point Thickness
Reproducibility and repeatability of Thinnest Point Thickness of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Lens Thickness
Reproducibility and repeatability of Lens Thickness of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Anterior Chamber Depth
Reproducibility and repeatability of Anterior Chamber Depth of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Axial Length
Reproducibility and repeatability of Axial Length of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Secondary outcomes (1)
Adverse Events Rate
Adverse events found during the clinical study
Measured: Through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start17 Apr 2024
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Why it stopped: newer version of the devices available for testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyes With Normal Anterior SegmentStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Fischer, MD, Principal investigator, Fischer Laser Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397976
- Sponsor's protocol ID
- B-2023-2
- Status last verified
- Nov 2024
- First submitted
- 30 Apr 2024
- Last updated
- 18 Mar 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
- ClinicalTrials.gov ID
- NCT06397976
- Acronym / sponsor ID
- B-2023-2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: newer version of the devices available for testing
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 3 May 2024 (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.
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes with normal anterior segment | – | Device: ANTERION investigational |
| Eyes with abnormal anterior segment | – | Device: ANTERION investigational |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eyes with normal and eyes with abnormal anterior segment population
Key inclusion criteria (8 listed)
- Age 22 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- Eye(s) with normal anterior segment
- Age 22 years or older
Key exclusion criteria (11 listed)
- Active infection or inflammation in the study eye
- Insufficient tear film or corneal reflex
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Rigid contact lens wear 2 weeks prior to imaging
- Soft lenses worn within one hour prior to imaging
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 |
|---|---|---|
| ANTERION investigationalMeasurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version) | Device | Eyes with abnormal anterior segment, Eyes with normal anterior segment |
Primary outcome
Central Cornea Thickness
Time frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Central Cornea Thickness of ANTERION and the reference device
Thinnest Point Thickness
Time frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Thinnest Point Thickness of ANTERION and the reference device
Lens Thickness
Time frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Lens Thickness of ANTERION and the reference device
Anterior Chamber Depth
Time frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Anterior Chamber Depth of ANTERION and the reference device
Axial Length
Time frame: Through study completion, an average of 1 day
Reproducibility and repeatability of Axial Length of ANTERION and the reference device
1 secondary outcome
Adverse Events Rate
Time frame: Through study completion, an average of 1 day
Results and safety
The study was stopped early (reason given: newer version of the devices available for testing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Related trials for Eyes With Normal Anterior Segment
Active, not recruitingObservational study
Heidelberg Engineering ANTERION Software Comparison Study
Eyes With Normal Anterior Segment, Eyes With Abnormal Anterior Segment
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.
Jeffrey Fischer, MD principal investigator
Fischer Laser Eye Center
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 Eyes With Normal Anterior Segment and Eyes With Abnormal Anterior Segment, run by Heidelberg Engineering GmbH 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Mar 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 was stopped early (reason given: newer version of the devices available for testing). Results are not available in the source record.
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 Cornea Thickness (time frame: Through study completion, an average of 1 day). The study lists 5 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 18 Mar 2025.