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Completed

NCT Number: NCT04130490

The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment parameters with the ANTERION

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Key information

Conditions

Cataract Cornea Abnormality Eye Diseases Healthy Eye IOL Lens Diseases Post-Keratorefractive Surgery

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

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 the following eye pathology status for the individual eye population:
  • A. Eye with normal anterior segment and crystalline lens
  • B. Eye with a cataract of grade 1.5 or higher
  • C. Eye with abnormal corneal shape
  • D. Eye with status post-keratorefractive surgery
  • E. Eye without a crystalline lens

Exclusion criteria

  • Subjects which were enrolled in the B-2018-1 clinical study
  • Active infection or inflammation in the study eye
  • Insufficient tear film or corneal reflex
  • Physical inability to be properly positioned at the study devices or eye exam equipment
  • Rigid contact lens wear 2 weeks prior to imaging
  • Soft lenses worn within one hour prior to imaging
  • With the following eye pathology status for the individual eye population:
  • A. Eye meets eligibility criteria for eye populations B, C, D or E
  • B. Eye meets eligibility criteria for eye populations C,D or E
  • C. Eye meets eligibility criteria for eye populations D or E
  • E. Eye with abnormal corneal shape (except status post-keratorefractive surgery)

Treatment and study plan

ANTERION

Device

3 repeat measurements performed with two of the ANTERION acquisition types and 3 repeat measurements performed with 2 acquisition types of the references devices

Primary outcomes

  1. Precision and Agreement 1

    Time frame: 1 day

    Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device

  2. Precision and Agreement 2

    Time frame: 1 day

    Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device

  3. Precision and Agreement 3

    Time frame: 1 day

    Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device

  4. Precision and Agreement 4

    Time frame: 1 day

    Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device

  5. Precision and Agreement 5

    Time frame: 1 day

    Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device

  6. Precision and Agreement 6

    Time frame: 1 day

    Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of ANTERION and the reference device

  7. Precision and Agreement 7

    Time frame: 1 day

    Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm^3) of ANTERION and the reference device

Secondary outcomes

  1. Adverse Events Rate

    Time frame: 1 day

    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
2023
Study completion
2023
First posted
Oct 17, 2019
Registry last updated
Apr 30, 2024

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.

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