Effect of Xen Implantation on the Aqueous Humor Proteome | NCT04141865

Studies
Effect of Xen Implantation on the Aqueous Humor Proteome

NCT04141865

Sponsor

Price Vision Group

Status

Terminated

Last Update Posted

Mar 3, 2022Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Primary Open Angle Glaucoma

Interventions

Xen
Aqueous shunt

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low enrollment

Expanded Access Info

Start Date

Oct 24, 2019Actual

Primary Completion Date

Feb 15, 2022Actual

Completion Date

Feb 15, 2022Actual

First Submitted Date

Oct 24, 2019

First Submission Date that Met QC Criteria

Oct 25, 2019

First Posted Date

Oct 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

Feb 15, 2022

Last Update Posted Date

Mar 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma.

Detailed Description

The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma using liquid chromatography mass spectrometry.

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

Retention

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Xen		Patients treated with a Xen microstent for glaucoma.	Device: Xen
Aqueous shunt		Patients treated with an aqueous shunt for glaucoma.	Device: Aqueous shunt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xen	Device	Xen microstent implantation	Xen
Aqueous shunt

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aqueous humor proteome	The aqueous humor proteome will be assessed with liquid chromotography/mass spectometry (quantitative LC-MS/MS).	Change from baseline at 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female of any racial or ethnic origin, 18 years or older
Able to provide written informed consent.
Scheduled to undergo Xen implantation for open angle glaucoma or already has an aqueous shunt

Exclusion Criteria:

History of conjunctivitis or any ocular infection within the past 3 weeks.
Any active inflammation of the cornea or the anterior chamber (uveitis)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with open angle glaucoma treated with a glaucoma drainage device.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francis Price, Jr, MD	Price Vision Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Price Vision Group		Indianapolis	Indiana	46260	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

de-identified data will be available upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020327	Glaucoma Drainage Implants

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided