CataractNCT04130490
The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study
An observational study of Cataract and Healthy Eye, 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 anterior segment 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
- Cataract, Healthy Eye, Cornea Abnormality
- What is being tested?
- ANTERION
- Type of treatment
- Medical device
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 30 Dec 2023
- 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 anterior segment and crystalline lens; eyes with cataract of grade 1.5 or higher; eyes with abnormal corneal shape; eyes with status post-keratorefractive surgery and eyes without a crystalline lens
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
- With the following eye pathology status for the individual eye population:
- A. Eye with normal anterior segment and crystalline lens
- B. Eye with a cataract of grade 1.5 or higher
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- C. Eye with abnormal corneal shape
- D. Eye with status post-keratorefractive surgery
- E. Eye without a crystalline lens
Who cannot join
- Subjects which were enrolled in the B-2018-1 clinical study
- 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
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- With the following eye pathology status for the individual eye population:
- A. Eye meets eligibility criteria for eye populations B, C, D or E
- B. Eye meets eligibility criteria for eye populations C,D or E
- C. Eye meets eligibility criteria for eye populations D or E
- E. Eye with abnormal corneal shape (except status post-keratorefractive surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York College of Optometry
New York, New York, 10036
About this study
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment parameters with the ANTERION
- Conditions
- Cataract, Healthy Eye, Cornea Abnormality, Post-Keratorefractive Surgery, IOL
- Being tested
- ANTERION
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTERIONDevice
3 repeat measurements performed with two of the ANTERION acquisition types and 3 repeat measurements performed with 2 acquisition types of the references devices
| Study group | Role | What they receive |
|---|---|---|
| Eye with normal Anterior Segment | 3 repeat measurements on each of the 3 investigational and reference devices Receives: Device: ANTERION | |
| Eye with cataract | 3 repeat measurements on each of the 3 investigational and reference devices Receives: Device: ANTERION | |
| Eye with corneal abnormality | 3 repeat measurements on each of the 3 investigational and reference devices Receives: Device: ANTERION | |
| Eye with status post-keratorefractive surgery | 3 repeat measurements on each of the 3 investigational and reference devices Receives: Device: ANTERION | |
| Eye without a crystalline lens | 3 repeat measurements on each of the 3 investigational and reference devices Receives: Device: ANTERION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision and Agreement 1
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Measured: 1 day
Precision and Agreement 2
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Measured: 1 day
Precision and Agreement 3
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Measured: 1 day
Precision and Agreement 4
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Measured: 1 day
Precision and Agreement 5
Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device
Measured: 1 day
Precision and Agreement 6
Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of ANTERION and the reference device
Measured: 1 day
Precision and Agreement 7
Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm^3) of ANTERION and the reference device
Measured: 1 day
Secondary outcomes (1)
Adverse Events Rate
Adverse events found during the clinical study
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start11 Oct 2019
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Dul, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130490
- Sponsor's protocol ID
- B-2018-5
- Status last verified
- Apr 2024
- First submitted
- 11 Oct 2019
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study
- ClinicalTrials.gov ID
- NCT04130490
- Acronym / sponsor ID
- B-2018-5
- Conditions
- Cataract, Healthy Eye, Cornea Abnormality, Post-Keratorefractive Surgery, IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 Oct 2019 (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 anterior segment parameters with the ANTERION
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Eye with normal Anterior Segment | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and reference devices |
| Eye with cataract | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and reference devices |
| Eye with corneal abnormality | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and reference devices |
| Eye with status post-keratorefractive surgery | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and reference devices |
| Eye without a crystalline lens | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and reference devices |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eyes with normal anterior segment and crystalline lens; eyes with cataract of grade 1.5 or higher; eyes with abnormal corneal shape; eyes with status post-keratorefractive surgery and eyes without a crystalline lens
Key inclusion criteria (9 listed)
- Age 22 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- With the following eye pathology status for the individual eye population:
Key exclusion criteria (11 listed)
- Subjects which were enrolled in the B-2018-1 clinical study
- 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
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 performed with two of the ANTERION acquisition types and 3 repeat measurements performed with 2 acquisition types of the references devices | Device | Eye with cataract, Eye with corneal abnormality, Eye with normal Anterior Segment, Eye with status post-keratorefractive surgery, Eye without a crystalline lens |
Primary outcome
Precision and Agreement 1
Time frame: 1 day
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 2
Time frame: 1 day
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 3
Time frame: 1 day
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 4
Time frame: 1 day
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 5
Time frame: 1 day
Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device
Precision and Agreement 6
Time frame: 1 day
Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of ANTERION and the reference device
Precision and Agreement 7
Time frame: 1 day
Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm^3) of ANTERION and the reference device
1 secondary outcome
Adverse Events Rate
Time frame: 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 30 Apr 2024.
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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.
Mitchell Dul principal investigator
State University of New York College of Optometry
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 Cataract and Healthy Eye, 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 9 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: finished, as of the sponsor's last update on 30 Apr 2024. 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?
Precision and Agreement 1 (time frame: 1 day). The study lists 7 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 30 Apr 2024.