The Heidelberg Engineering ANTERION Imaging Agreement Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04068818

Enrollment

Registered

2019-08-28

Start date

2019-08-22

Completion date

2021-04-27

Last updated

2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Abnormalities, Normal Eyes

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 Trial per Clinicaltrials.gov definition.

Interventions

DEVICEANTERION

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Age 22 years or older 2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions 3. Able to fixate 4. 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 criteria

1. Subjects which were enrolled in the B-2018-1 Study 2. Physical inability to be properly positioned at the study devices or eye exam equipment 3. Contact lenses worn during imaging

Design outcomes

Primary

Measure	Time frame	Description
Image quality	30 days	Comparison of the B-Scan image quality between the ANTERION and the reference device
Agreement in identification of abnormality	30 days	Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device

Secondary

Measure	Time frame	Description
Adverse Events	1 day	Evaluate any adverse events found during the clinical study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026