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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130490
• Other study ID #: B-2018-5
• Status: Completed
• Start date: October 11, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2024
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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 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:

1. Subjects which were enrolled in the B-2018-1 clinical study

2. Active infection or inflammation in the study eye

3. Insufficient tear film or corneal reflex

4. Physical inability to be properly positioned at the study devices or eye exam equipment

5. Rigid contact lens wear 2 weeks prior to imaging

6. Soft lenses worn within one hour prior to imaging

7. 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)

Related Conditions & MeSH terms

• Cataract
• Corneal Diseases
• IOL

Intervention

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

Locations

Country	Name	City	State
United States	State University of New York College of Optometry	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg Engineering GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision and Agreement 1	Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device	1 day
Primary	Precision and Agreement 2	Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device	1 day
Primary	Precision and Agreement 3	Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device	1 day
Primary	Precision and Agreement 4	Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device	1 day
Primary	Precision and Agreement 5	Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device	1 day
Primary	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
Primary	Precision and Agreement 7	Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm^3) of ANTERION and the reference device	1 day
Secondary	Adverse Events Rate	Adverse events found during the clinical study	1 day