Status:
COMPLETED
The Heidelberg Engineering ANTERION Imaging Agreement Study
Lead Sponsor:
Heidelberg Engineering GmbH
Conditions:
Eye Abnormalities
Normal Eyes
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 image quality of acquired biometry images of the eye
Detailed Description
The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Tri...
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 eye pathology status for each of the two eye populations. A. Eye with normal anterior segment
- B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:
- glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices
- corneal surgeries: corneal inlays and corneal transplants
- pterygium and corneal scar
Exclusion
- Subjects which were enrolled in the B-2018-1 Study
- Physical inability to be properly positioned at the study devices or eye exam equipment
- Contact lenses worn during imaging
Key Trial Info
Start Date :
August 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04068818
Start Date
August 22 2019
End Date
April 27 2021
Last Update
August 4 2022
Active Locations (1)
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1
State University of New York College of Optometry
New York, New York, United States, 10036