The Heidelberg Engineering ANTERION Imaging Agreement Study

Heidelberg Engineering GmbH87 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eye Abnormalities Normal Eyes

Interventions

ANTERIONDEVICE

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

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

State University of New York College of Optometry

New York, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Adverse Events

Evaluate any adverse events found during the clinical study

Time frame: 1 day

Data from ClinicalTrials.gov

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