The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
NCT ID: NCT06397976
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
37 participants
OBSERVATIONAL
2024-04-17
2024-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Eyes with normal anterior segment
ANTERION investigational
Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)
Eyes with abnormal anterior segment
ANTERION investigational
Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)
Interventions
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ANTERION investigational
Measurements from the investigational device ANTERION with software version 1.5 are to be compared against measurements from the ANTERION with software version 1.2.4 (cleared version)
Eligibility Criteria
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Inclusion Criteria
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
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
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
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
22 Years
ALL
Yes
Sponsors
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Heidelberg Engineering GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Fischer, MD
Role: PRINCIPAL_INVESTIGATOR
Fischer Laser Eye Center
Locations
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Fischer Eye Laser Center
Willmar, Minnesota, United States
Countries
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Other Identifiers
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B-2023-2
Identifier Type: -
Identifier Source: org_study_id
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