The Heidelberg Engineering ANTERION Imaging Agreement Study | NCT04068818

Studies
The Heidelberg Engineering ANTERION Imaging Agreement Study

NCT04068818

Sponsor

Heidelberg Engineering GmbH

Status

Completed

Last Update Posted

Aug 4, 2022Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Eye Abnormalities
Normal Eyes

Interventions

ANTERION

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2019Actual

Primary Completion Date

Apr 27, 2021Actual

Completion Date

Apr 27, 2021Actual

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eyes with normal anterior segment			Device: ANTERION
Eyes with anterior segment abnormalities			Device: ANTERION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANTERION	Device	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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 22 years or older
Able and willing to undergo the test procedures, sign informed consent, and follow instructions
Able to fixate
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:

Subjects which were enrolled in the B-2018-1 Study
Physical inability to be properly positioned at the study devices or eye exam equipment
Contact lenses worn during imaging

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A: normal eyes B: eyes with anterior segment abnormalities

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mitchell Dul	State University of New York College of Optometry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State University of New York College of Optometry		New York	New York	10036	United States

Condition Browse Module

MeSH Terms

ID	Term
D005124	Eye Abnormalities

Ancestor Terms

ID	Term
D005128	Eye Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided