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

Completed

• Conditions: Cataract; IOL; Cornea Abnormality; Healthy Eye; Post-Keratorefractive Surgery
• Interventions: Device: ANTERION

• Registration Number: NCT04130490
• Lead Sponsor: Heidelberg Engineering GmbH

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-11
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eye with normal Anterior Segment	ANTERION	3 repeat measurements on each of the 3 investigational and reference devices
Eye with status post-keratorefractive surgery	ANTERION	3 repeat measurements on each of the 3 investigational and reference devices
Eye without a crystalline lens	ANTERION	3 repeat measurements on each of the 3 investigational and reference devices
Eye with cataract	ANTERION	3 repeat measurements on each of the 3 investigational and reference devices
Eye with corneal abnormality	ANTERION	3 repeat measurements on each of the 3 investigational and reference devices

Primary Outcome Measures

Name	Time	Method
Precision and Agreement 2	1 day	Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 4	1 day	Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 5	1 day	Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device
Precision and Agreement 1	1 day	Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 6	1 day	Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of ANTERION and the reference device
Precision and Agreement 3	1 day	Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 7	1 day	Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm\^3) of ANTERION and the reference device

Secondary Outcome Measures

Name	Time	Method
Adverse Events Rate	1 day	Adverse events found during the clinical study

Trial Locations

Locations (1)

State University of New York College of Optometry; 🇺🇸 New York, New York, United States