Effect of Xen Implantation on the Aqueous Humor Proteome

Terminated

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: Xen; Device: Aqueous shunt

• Registration Number: NCT04141865
• Lead Sponsor: Price Vision Group

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.

Study Timeline

• Study Start: 2019-10-24
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Status Verified: 2022-02
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Xen	Xen	Patients treated with a Xen microstent for glaucoma.
Aqueous shunt	Aqueous shunt	Patients treated with an aqueous shunt for glaucoma.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States