Status:
COMPLETED
The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study
Lead Sponsor:
Heidelberg Engineering GmbH
Conditions:
Cataract
Healthy Eye
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 parameters 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 the following eye pathology status for the individual eye population:
- A. Eye with normal anterior segment and crystalline lens
- B. Eye with a cataract of grade 1.5 or higher
- C. Eye with abnormal corneal shape
- D. Eye with status post-keratorefractive surgery
- E. Eye without a crystalline lens
Exclusion
- Subjects which were enrolled in the B-2018-1 clinical study
- Active infection or inflammation in the study 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 2 weeks prior to imaging
- Soft lenses worn within one hour prior to imaging
- With the following eye pathology status for the individual eye population:
- A. Eye meets eligibility criteria for eye populations B, C, D or E
- B. Eye meets eligibility criteria for eye populations C,D or E
- C. Eye meets eligibility criteria for eye populations D or E
- E. Eye with abnormal corneal shape (except status post-keratorefractive surgery)
Key Trial Info
Start Date :
October 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04130490
Start Date
October 11 2019
End Date
December 30 2023
Last Update
April 30 2024
Active Locations (1)
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1
State University of New York College of Optometry
New York, New York, United States, 10036