The Heidelberg Engineering ANTERION Imaging Agreement Study

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

Study Overview

• Status: Completed
• Conditions: Eye Abnormalities; Normal Eyes
• Intervention / Treatment: Device: ANTERION

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 Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10036
      • State University of New York College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A: normal eyes B: eyes with anterior segment abnormalities

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eyes with normal anterior segment	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
Eyes with anterior segment abnormalities	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Evaluate any adverse events found during the clinical study	1 day

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Mitchell Dul, State University of New York College of Optometry

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2019
• Primary Completion (ACTUAL): April 27, 2021
• Study Completion (ACTUAL): April 27, 2021

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Eye Abnormalities
• Other Study ID Numbers: B-2018-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No