Normal CorneaNCT05051813
The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study
An observational study of Normal Cornea and Corneal Abnormality, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess corneal epithelial thickness parameters with the ANTERION Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Cornea, Corneal Abnormality
- What is being tested?
- ANTERION
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 16 Dec 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: Normal and Abnormal Cornea populations
Who may be able to join
- Subjects ≥ 22 years of age
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- With at least one of the following eye status for the corresponding eye population:
- Normal Cornea
- Abnormal Cornea: eye with at least one of the following
- Keratoconus b) Contact Lens Wearer c) Status Post-Keratorefractive Surgery (at least 30 days between imaging and Keratorefractive Surgery) d) Dry Eye Disease
Who cannot join
- Active infection in either eye
- Insufficient corneal reflex, in the study eye
- Physical inability to be properly positioned at the study devices or eye exam equipment
- 4. Abnormal cornea shape or corneal surgery in the study eye
- 5. Contact lens wear within 3 months prior to imaging in the study eye
- 6. Dry eye disease in the study eye
Show all 19Show fewer
- 4. For Keratoconus (a):
- Contact lenses worn within one hour prior to imaging
- 5. For Contact Lens Wearer (b):
- Keratoconus
- Post-Keratorefractive surgery
- Contact lenses worn within one hour prior to imaging
- 6. For Post-Keratorefractive Surgery (c):
- Keratoconus
- Contact lens wear within 3 months prior to imaging in the study eye
- 7. For Dry Eye Disease (d):
- Keratoconus
- Post-Keratorefractive surgery
- Contact lens wear within 3 months prior to imaging in the study eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Fischer Laser Eye Center
Minneapolis, Minnesota, 56201
About this study
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess corneal epithelial thickness parameters with the ANTERION
- Conditions
- Normal Cornea, Corneal Abnormality
- Being tested
- ANTERION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTERIONDevice
3 repeat measurements on each of the 3 ANTERION devices and 3 reference devices.
| Study group | Role | What they receive |
|---|---|---|
| Normal Cornea | 3 repeat measurements on each of the 3 investigational and 3 reference devices Receives: Device: ANTERION | |
| Corneal Abnormality | 3 repeat measurements on each of the 3 investigational and 3 reference devices Receives: Device: ANTERION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Epithelial Thickness 0-2mm ring
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (0-2mm ring) of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Corneal Epithelial Thickness 2-5mm ring
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Corneal Epithelial Thickness 5-7mm ring
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Minimum Thickness from 7mm zone
Reproducibility and repeatability of minimum thickness (7mm zone) of ANTERION and the reference device
Measured: Through study completion, an average of 1 day
Maximum Thickness from 7mm zone
Reproducibility and repeatability of maximum thickness (7mm zone) 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 posted21 Sep 2021
- Study start7 Sep 2021
- Primary completion28 Feb 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal CorneaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 151 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, Fischerr Laser Eye Center, MN, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051813
- Sponsor's protocol ID
- B-2020-1
- Status last verified
- Jan 2025
- First submitted
- 8 Sep 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study
- ClinicalTrials.gov ID
- NCT05051813
- Acronym / sponsor ID
- B-2020-1
- Conditions
- Normal Cornea, Corneal Abnormality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 21 Sep 2021 (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 is a prospective clinical study that will be conducted at one clinical site located in the United States to assess corneal epithelial thickness parameters with the ANTERION
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Cornea | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and 3 reference devices |
| Corneal Abnormality | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and 3 reference devices |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal and Abnormal Cornea populations
Key inclusion criteria (7 listed)
- Subjects ≥ 22 years of age
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- With at least one of the following eye status for the corresponding eye population:
Key exclusion criteria (19 listed)
- 4. Abnormal cornea shape or corneal surgery in the study eye
- 5. Contact lens wear within 3 months prior to imaging in the study eye
- 6. Dry eye disease in the study eye
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 |
|---|---|---|
| ANTERION3 repeat measurements on each of the 3 ANTERION devices and 3 reference devices. | Device | Corneal Abnormality, Normal Cornea |
Primary outcome
Corneal Epithelial Thickness 0-2mm ring
Time frame: Through study completion, an average of 1 day
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (0-2mm ring) of ANTERION and the reference device
Corneal Epithelial Thickness 2-5mm ring
Time frame: Through study completion, an average of 1 day
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device
Corneal Epithelial Thickness 5-7mm ring
Time frame: Through study completion, an average of 1 day
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device
Minimum Thickness from 7mm zone
Time frame: Through study completion, an average of 1 day
Reproducibility and repeatability of minimum thickness (7mm zone) of ANTERION and the reference device
Maximum Thickness from 7mm zone
Time frame: Through study completion, an average of 1 day
Reproducibility and repeatability of maximum thickness (7mm zone) 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 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 15 Jan 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.
Jeffrey Fischer, MD principal investigator
Fischerr Laser Eye Center, MN, USA
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 Cornea and Corneal Abnormality, 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 7 inclusion and 19 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 15 Jan 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?
Corneal Epithelial Thickness 0-2mm ring (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 15 Jan 2025.