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

Heidelberg Engineering

Status: Completed

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

Treatments: Device: ANTERION

Study type: Observational

Funder types: Industry

Identifiers

NCT04130490

B-2018-5

Details and patient eligibility

About

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

Enrollment: 176 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

176 participants in 5 patient groups

Eye with normal Anterior Segment

Description:

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

Treatment:

Device: ANTERION

Eye with cataract

Description:

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

Treatment:

Device: ANTERION

Eye with corneal abnormality

Description:

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

Treatment:

Device: ANTERION

Eye with status post-keratorefractive surgery

Description:

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

Treatment:

Device: ANTERION

Eye without a crystalline lens

Description:

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

Treatment:

Device: ANTERION