Narrow AngleNCT04083742
The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study
An observational study of Narrow Angle and Open Angle, 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 metrics 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
- Narrow Angle, Open Angle
- What is being tested?
- ANTERION
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 31 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 narrow angle and eyes with open angle
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 at least one of following eye status for the corresponding eye population:
- Eye with Open Angle (defined by Spaeth gonioscopy grading)
- Eye with Narrow Angle (defined by Spaeth gonioscopy grading)
Who cannot join
- Subjects which were enrolled in the B-2018-1 study
- Active infection or inflammation in either 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 during 2 weeks prior to day when study device acquisitions take place
- Soft lenses worn within one hour prior to study device acquisitions
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 metrics with the ANTERION
- Conditions
- Narrow Angle, Open Angle
- 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 angle measurements performed on each of the 3 Anterion devices and the 3 reference devices
| Study group | Role | What they receive |
|---|---|---|
| Eyes with Open Angle | 3 repeat measurements on each of the 3 investigational and reference devices Receives: Device: ANTERION | |
| Eyes with Narrow Angle | 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.
Repeatability and Reproducibility 1
Reproducibility and repeatability of Spur to Spur distance parameter [mm] of ANTERION and the reference device
Measured: 1 day
Repeatability and Reproducibility 2
Reproducibility and repeatability of Angle to Angle distance parameter [mm] of ANTERION and the reference device
Measured: 1 day
Repeatability and Reproducibility 3
Reproducibility and repeatability of Lens Vault parameter [µm] of ANTERION and the reference device
Measured: 1 day
Repeatability and Reproducibility 4
Reproducibility and repeatability of Anterior Segment Angles parameter [°] of ANTERION and the reference device
Measured: 1 day
Repeatability and Reproducibility 5
Reproducibility and repeatability of TISA parameters [mm2] of ANTERION and the reference device
Measured: 1 day
Repeatability and Reproducibility 6
Reproducibility and repeatability of AOD parameters [µm] of ANTERION and the reference device
Measured: 1 day
Agreement 1
Agreement of Spur to Spur distance parameter [mm] between the ANTERION and the reference device
Measured: 1 day
Agreement 2
Agreement of Angle to Angle distance parameter [mm] between the ANTERION and the reference device
Measured: 1 day
Agreement 3
Agreement of Lens Vault parameter [µm] between the ANTERION and the reference device
Measured: 1 day
Agreement 4
Agreement of Anterior Segment Angles parameter [°] between the ANTERION and the reference device
Measured: 1 day
Agreement 5
Agreement of TISA parameters [mm2] between the ANTERION and the reference device
Measured: 1 day
Agreement 6
Agreement of AOD parameters [µm] between the 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 posted10 Sep 2019
- Study start22 Aug 2019
- Primary completion15 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrow AngleStudies 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
- 59 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
- NCT04083742
- Sponsor's protocol ID
- B-2018-3
- Status last verified
- Jun 2024
- First submitted
- 23 Aug 2019
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study
- ClinicalTrials.gov ID
- NCT04083742
- Acronym / sponsor ID
- B-2018-3
- Conditions
- Narrow Angle, Open Angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Sep 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 metrics with the ANTERION
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes with Open Angle | – | Device: ANTERION3 repeat measurements on each of the 3 investigational and reference devices |
| Eyes with Narrow Angle | – | 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 narrow angle and eyes with open angle
Key inclusion criteria (6 listed)
- Age 22 years or older
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- Able to fixate
- With at least one of following eye status for the corresponding eye population:
- Eye with Open Angle (defined by Spaeth gonioscopy grading)
Key exclusion criteria (6 listed)
- Subjects which were enrolled in the B-2018-1 study
- Active infection or inflammation in either 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 during 2 weeks prior to day when study device acquisitions take place
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 angle measurements performed on each of the 3 Anterion devices and the 3 reference devices | Device | Eyes with Narrow Angle, Eyes with Open Angle |
Primary outcome
Repeatability and Reproducibility 1
Time frame: 1 day
Reproducibility and repeatability of Spur to Spur distance parameter [mm] of ANTERION and the reference device
Repeatability and Reproducibility 2
Time frame: 1 day
Reproducibility and repeatability of Angle to Angle distance parameter [mm] of ANTERION and the reference device
Repeatability and Reproducibility 3
Time frame: 1 day
Reproducibility and repeatability of Lens Vault parameter [µm] of ANTERION and the reference device
Repeatability and Reproducibility 4
Time frame: 1 day
Reproducibility and repeatability of Anterior Segment Angles parameter [°] of ANTERION and the reference device
Repeatability and Reproducibility 5
Time frame: 1 day
Reproducibility and repeatability of TISA parameters [mm2] of ANTERION and the reference device
Repeatability and Reproducibility 6
Time frame: 1 day
Reproducibility and repeatability of AOD parameters [µm] of ANTERION and the reference device
Agreement 1
Time frame: 1 day
Agreement of Spur to Spur distance parameter [mm] between the ANTERION and the reference device
Agreement 2
Time frame: 1 day
Agreement of Angle to Angle distance parameter [mm] between the ANTERION and the reference device
Agreement 3
Time frame: 1 day
Agreement of Lens Vault parameter [µm] between the ANTERION and the reference device
Agreement 4
Time frame: 1 day
Agreement of Anterior Segment Angles parameter [°] between the ANTERION and the reference device
Agreement 5
Time frame: 1 day
Agreement of TISA parameters [mm2] between the ANTERION and the reference device
Agreement 6
Time frame: 1 day
Agreement of AOD parameters [µm] between the 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 21 Jun 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 Narrow Angle and Open Angle, 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 6 inclusion and 6 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 21 Jun 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?
Repeatability and Reproducibility 1 (time frame: 1 day). The study lists 12 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 21 Jun 2024.