A Prospective Trial of the Intelon BOSS(TM) System | NCT04969406

Studies
A Prospective Trial of the Intelon BOSS(TM) System

NCT04969406

Sponsor

Intelon Optics, Inc

Status

Terminated

Last Update Posted

Jun 10, 2022Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Cornea
Lens Diseases

Interventions

Brillouin Spectroscopy via BOSS System

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment Difficulty

Expanded Access Info

Start Date

Jul 24, 2021Actual

Primary Completion Date

Dec 10, 2021Actual

Completion Date

Dec 10, 2021Actual

First Submitted Date

Jul 7, 2021

First Submission Date that Met QC Criteria

Jul 16, 2021

First Posted Date

Jul 20, 2021Actual

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

Jun 8, 2022

Last Update Posted Date

Jun 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imaging by BOSS System	Experimental	Imaging by the BOSS System	Other: Brillouin Spectroscopy via BOSS System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brillouin Spectroscopy via BOSS System	Other	Biomechanical Imaging of the Cornea and Lens	Imaging by BOSS System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility	A random effect model will be used to assess variation due to device/operator configuration	Evaluation Visit (within 30 days of the Screening Visit)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
Signed Written Informed Consent

Exclusion Criteria:

No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
Presence of corneal opacity
Presence of cortical cataracts visible in an undilated pupil
Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vold Vision plc		Fayetteville	Arkansas	72704	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003316	Corneal Diseases
D007905	Lens Diseases

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided