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

NCT04130490 | Completed FDA Device

• 1 other identifier: B-2018-5
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract; Healthy Eye; Cornea Abnormality; Post-Keratorefractive Surgery; IOL

Outcome Measures

Primary Outcomes (7)

• Precision and Agreement 1

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

  1 day

• Precision and Agreement 2

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

  1 day

• Precision and Agreement 3

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

  1 day

• Precision and Agreement 4

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

  1 day

• Precision and Agreement 5

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

  1 day

• Precision and Agreement 6

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

  1 day

• Precision and Agreement 7

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

  1 day

Secondary Outcomes (1)

• Adverse Events Rate

  1 day

Study Arms (5)

Eye with normal Anterior Segment

3 repeat measurements on each of the 3 investigational and reference devices

Device: ANTERION

Eye with cataract

3 repeat measurements on each of the 3 investigational and reference devices

Device: ANTERION

Eye with corneal abnormality

3 repeat measurements on each of the 3 investigational and reference devices

Device: ANTERION

Eye with status post-keratorefractive surgery

3 repeat measurements on each of the 3 investigational and reference devices

Device: ANTERION

Eye without a crystalline lens

3 repeat measurements on each of the 3 investigational and reference devices

Device: ANTERION

Interventions

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

Eye with cataract; Eye with corneal abnormality; Eye with normal Anterior Segment; Eye with status post-keratorefractive surgery; Eye without a crystalline lens

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eyes with normal anterior segment and crystalline lens; eyes with cataract of grade 1.5 or higher; eyes with abnormal corneal shape; eyes with status post-keratorefractive surgery and eyes without a crystalline lens

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

State University of New York College of Optometry

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Mitchell Dul

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 17, 2019
• Study Start: October 11, 2019
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

US (1)