The Heidelberg Engineering ANTERION Imaging Agreement Study

Completed

• Conditions: Eye Abnormalities; Normal Eyes
• Interventions: Device: ANTERION

• Registration Number: NCT04068818
• 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 image quality of acquired biometry images of the eye

Detailed 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.

Study Timeline

• Study Start: 2019-08-22
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eyes with anterior segment abnormalities	ANTERION	-
Eyes with normal anterior segment	ANTERION	-

Primary Outcome Measures

Name	Time	Method
Image quality	30 days	Comparison of the B-Scan image quality between the ANTERION and the reference device
Agreement in identification of abnormality	30 days	Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 day	Evaluate any 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