An observational study in Normal Eyes and Eye Abnormalities, sponsored by Heidelberg Engineering GmbH. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Heidelberg Engineering GmbH (part of EssilorLuxottica) · Observational
Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI
The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability
28 studies on the registry are indexed under Eye Abnormalities; 3 are open to participants now.
This study's enrollment of 39 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.
Subjects with:
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Able and willing to undergo the test procedures, sign , and follow instructions
At least one of the following:
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.
single measurement Anterior Segment Pathology
Device: BI Anterior Segment Mode
3 repeat measurements with and without dilation for all eyes except Anterior Segment Pathology
Device: BI Anterior Segment and IOL Biometry Mode
Single eye measurement in Anterior Segment Mode
Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode
Percentage of successfully scanned biometry images of the eye
Percentage of successfully scanned biometry images of the eyes per scan mode. Success is defined as agreement of the subjective assessment of the operator and the auto assessment of the device.
Time frame: 1 day
Repeatabiltiy of specific parameters of the biometry images of the eye
Repeatability of specific parameters stratified by different eye pathologies
Time frame: 1 day
Ran from May 2018 to primary completion in Dec 2018, 6 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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