Skip to main content
OpenTrials
Completed

NCT Number: NCT04068818

The Heidelberg Engineering ANTERION Imaging Agreement Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eye Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Normal Eyes

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

State University of New York College of Optometry

New York, 10036, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ANTERION

Device

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

Primary outcomes

  1. Image quality

    Time frame: 30 days

    Comparison of the B-Scan image quality between the ANTERION and the reference device

  2. Agreement in identification of abnormality

    Time frame: 30 days

    Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device

Secondary outcomes

  1. Adverse Events

    Time frame: 1 day

    Evaluate any adverse events found during the clinical study

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.