The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Narrow Angle
- Sponsor
- Heidelberg Engineering GmbH
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Repeatability and Reproducibility 2
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Repeatability and Reproducibility 2
Time Frame: 1 day
Reproducibility and repeatability of Angle to Angle distance parameter \[mm\] 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 5
Time Frame: 1 day
Agreement of TISA parameters \[mm2\] between the 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 6
Time Frame: 1 day
Agreement of AOD parameters \[µm\] between the ANTERION and the reference device
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 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
Agreement 4
Time Frame: 1 day
Agreement of Anterior Segment Angles parameter \[°\] between the ANTERION and the reference device
Secondary Outcomes
- Adverse Events Rate(1 day)