Comparison of ANTERION software versions for eye imaging
The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
Heidelberg Engineering GmbH · NCT06657716
This study is testing two different software versions of the ANTERION eye imaging device to see which one works better for people with normal or abnormal eye conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Heidelberg Engineering GmbH (industry) |
| Locations | 1 site (Willmar, Minnesota) |
| Trial ID | NCT06657716 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the performance of the ANTERION device using two different software versions: the investigational version 1.5 and the cleared version 1.2.4. Participants will include individuals with either normal or abnormal anterior segments of the eye. The study will assess the effectiveness and reliability of the imaging capabilities of the ANTERION device across these software versions. Eligible participants must be 22 years or older and able to comply with the study procedures.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 22 years or older with either normal or abnormal anterior segments of the eye.
Not a fit: Patients with active infections or inflammation in the eye, or those unable to comply with imaging requirements, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of eye imaging, leading to better diagnosis and treatment planning for patients with anterior segment conditions.
How similar studies have performed: While this study focuses on a specific software comparison, similar studies evaluating imaging technologies have shown promising results in improving diagnostic capabilities.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Normal Anterior Segment 1. Age 22 years or older 2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions 3. Able to fixate 4. Eye(s) with normal anterior segment Exclusion Criteria Normal Anterior Segment 1. Active infection or inflammation in the study eye 2. Insufficient tear film or corneal reflex 3. Physical inability to be properly positioned at the study devices or eye exam equipment 4. Rigid contact lens wear 2 weeks prior to imaging 5. Soft lenses worn within one hour prior to imaging 6. Cataract grade ≥1.5 Inclusion Criteria Abnormal Anterior Segment 1. Age 22 years or older 2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions 3. Able to fixate 4. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5) Exclusion Criteria Abnormal Anterior Segment 1. Active infection or inflammation in the study eye 2. Insufficient tear film or corneal reflex 3. Physical inability to be properly positioned at the study devices or eye exam equipment 4. Rigid contact lens wear 2 weeks prior to imaging 5. Soft lenses worn within one hour prior to imaging
Where this trial is running
Willmar, Minnesota
- Fischer Eye Laser Center — Willmar, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey Fischer, MD — Fischer Laser Eye Center
- Study coordinator: Heather Oakes
- Email: heather.oakes@heidelbergengineering.com
- Phone: 1-508-530-7837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eyes With Normal Anterior Segment, Eyes With Abnormal Anterior Segment