The Heidelberg Engineering ANTERION Imaging Agreement Study

Eye Abnormalities Clinical Trial

Official title:

The Heidelberg Engineering ANTERION Imaging Agreement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068818
• Other study ID #: B-2018-4
• Status: Completed
• Start date: August 22, 2019
• Est. completion date: April 27, 2021

Study information

• Verified date: August 2022
• 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 image quality of acquired biometry images of the eye

Description:

The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• 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 eye pathology status for each of the two eye populations. A. Eye with normal anterior segment

B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:

• glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices

• corneal surgeries: corneal inlays and corneal transplants

• pterygium and corneal scar

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 Study

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

3. Contact lenses worn during imaging

Related Conditions & MeSH terms

• Eye Abnormalities
• Normal Eyes

Intervention

Device:
• ANTERION
Biometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center

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	Image quality	Comparison of the B-Scan image quality between the ANTERION and the reference device	30 days
Primary	Agreement in identification of abnormality	Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device	30 days
Secondary	Adverse Events	Evaluate any adverse events found during the clinical study	1 day