The Heidelberg Engineering ANTERION Imaging Agreement Study
1 other identifier
observational
87
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2019
CompletedFirst Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2021
CompletedAugust 4, 2022
August 1, 2022
1.7 years
August 23, 2019
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Image quality
Comparison of the B-Scan image quality between the ANTERION and the reference device
30 days
Agreement in identification of abnormality
Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device
30 days
Secondary Outcomes (1)
Adverse Events
1 day
Study Arms (2)
Eyes with normal anterior segment
Eyes with anterior segment abnormalities
Interventions
Biometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center
Eligibility Criteria
A: normal eyes B: eyes with anterior segment abnormalities
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State University of New York College of Optometry
New York, New York, 10036, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Dul
State University of New York College of Optometry
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start
August 22, 2019
Primary Completion
April 27, 2021
Study Completion
April 27, 2021
Last Updated
August 4, 2022
Record last verified: 2022-08