Status:
COMPLETED
The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study
Lead Sponsor:
Heidelberg Engineering GmbH
Conditions:
Narrow Angle
Open Angle
Eligibility:
All Genders
22+ years
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04083742
Start Date
August 22 2019
End Date
December 31 2023
Last Update
June 21 2024
Active Locations (1)
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1
State University of New York College of Optometry
New York, New York, United States, 10036