Eye AbnormalitiesNCT04068818
The Heidelberg Engineering ANTERION Imaging Agreement Study
An observational study of Eye Abnormalities and Normal Eyes, 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 image quality of acquired biometry images of the eye Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Abnormalities, Normal Eyes
- What is being tested?
- ANTERION
- Type of treatment
- Medical device
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 27 Apr 2021
- 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: A: normal eyes B: eyes with anterior segment abnormalities
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 eye pathology status for each of the two eye populations. A. Eye with normal anterior segment
- Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:
- glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices
- corneal surgeries: corneal inlays and corneal transplants
- pterygium and corneal scar
Who cannot join
- Subjects which were enrolled in the B-2018-1 Study
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Contact lenses worn during imaging
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 image quality of acquired biometry images of the eye
Read the detailed description
The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.
- Conditions
- Eye Abnormalities, Normal Eyes
- Being tested
- ANTERION
- Medical subject headings
- Eye Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTERIONDevice
Biometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center
| Study group | Role | What they receive |
|---|---|---|
| Eyes with normal anterior segment | Not described Receives: Device: ANTERION | |
| Eyes with anterior segment abnormalities | Not described Receives: Device: ANTERION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
Comparison of the B-Scan image quality between the ANTERION and the reference device
Measured: 30 days
Agreement in identification of abnormality
Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device
Measured: 30 days
Secondary outcomes (1)
Adverse Events
Evaluate any 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 posted28 Aug 2019
- Study start22 Aug 2019
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye AbnormalitiesStudies 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
- 87 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
- NCT04068818
- Sponsor's protocol ID
- B-2018-4
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2019
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heidelberg Engineering ANTERION Imaging Agreement Study
- ClinicalTrials.gov ID
- NCT04068818
- Acronym / sponsor ID
- B-2018-4
- Conditions
- Eye Abnormalities, Normal Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 28 Aug 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 image quality of acquired biometry images of the eye
Detailed description
The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes with normal anterior segment | – | Device: ANTERION |
| Eyes with anterior segment abnormalities | – | Device: ANTERION |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A: normal eyes B: eyes with anterior segment abnormalities
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
- With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment
- Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:
Key exclusion criteria (3 listed)
- Subjects which were enrolled in the B-2018-1 Study
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Contact lenses worn during 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 |
|---|---|---|
| ANTERIONBiometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center | Device | Eyes with anterior segment abnormalities, Eyes with normal anterior segment |
Primary outcome
Image quality
Time frame: 30 days
Comparison of the B-Scan image quality between the ANTERION and the reference device
Agreement in identification of abnormality
Time frame: 30 days
Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device
1 secondary outcome
Adverse Events
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 4 Aug 2022.
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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 Eye Abnormalities and Normal Eyes, 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 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: finished, as of the sponsor's last update on 4 Aug 2022. 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?
Image quality (time frame: 30 days). The study lists 2 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 4 Aug 2022.