The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
- Conditions
- Eyes with Normal Anterior SegmentEyes with Abnormal Anterior Segment
- Interventions
- Device: ANTERION investigational
- Registration Number
- NCT06397976
- Lead Sponsor
- Heidelberg Engineering GmbH
- Brief Summary
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Eyes with abnormal anterior segment ANTERION investigational - Eyes with normal anterior segment ANTERION investigational -
- Primary Outcome Measures
Name Time Method Anterior Chamber Depth Through study completion, an average of 1 day Reproducibility and repeatability of Anterior Chamber Depth of ANTERION and the reference device
Central Cornea Thickness Through study completion, an average of 1 day Reproducibility and repeatability of Central Cornea Thickness of ANTERION and the reference device
Axial Length Through study completion, an average of 1 day Reproducibility and repeatability of Axial Length of ANTERION and the reference device
Lens Thickness Through study completion, an average of 1 day Reproducibility and repeatability of Lens Thickness of ANTERION and the reference device
Thinnest Point Thickness Through study completion, an average of 1 day Reproducibility and repeatability of Thinnest Point Thickness of ANTERION and the reference device
- Secondary Outcome Measures
Name Time Method Adverse Events Rate Through study completion, an average of 1 day Adverse events found during the clinical study
Trial Locations
- Locations (1)
Fischer Eye Laser Center
🇺🇸Willmar, Minnesota, United States