An observational study in Eye Abnormalities and Normal Eyes, sponsored by Heidelberg Engineering GmbH. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by Heidelberg Engineering GmbH (part of EssilorLuxottica) · Observational
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
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 Trial per Clinicaltrials.gov definition.
28 studies on the registry are indexed under Eye Abnormalities; 3 are open to participants now.
This study's enrollment of 87 is below the median of 100 across 14 observational studies indexed under Eye Abnormalities.
Browse Eye Abnormalities studies →Heidelberg Engineering GmbH is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
First submitted before Heidelberg Engineering GmbH became part of EssilorLuxottica.
Counted across the registry records on this site, refreshed daily.
A: normal eyes B: eyes with anterior segment abnormalities
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: ANTERION
Device: ANTERION
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
Image quality
Comparison of the B-Scan image quality between the ANTERION and the reference device
Time frame: 30 days
Agreement in identification of abnormality
Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device
Time frame: 30 days
Adverse Events
Evaluate any adverse events found during the clinical study
Time frame: 1 day
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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