State University of New York College of Optometry
New York, 10036, United States
Completed
NCT Number: NCT04083742
The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement 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
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
22 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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:
A. Eye with Open Angle (defined by Spaeth gonioscopy grading)
B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)
Exclusion criteria
- 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
Treatment and study plan
ANTERION
Device3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices
Primary outcomes
-
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
Secondary outcomes
-
Adverse Events Rate
Time frame: 1 day
Adverse events found during the clinical study
Sponsors and collaborators
Lead sponsor
Heidelberg Engineering GmbH
Industry
Registry information
Important dates
- Study start
- 2019
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Sep 10, 2019
- Registry last updated
- Jun 21, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.