Effect of Xen Implantation on the Aqueous Humor Proteome

• Sponsor: Price Vision Group (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04141865
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Actual Duration (Months): 27.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma	Device: Xen; Device: Aqueous shunt

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 Design

• Study Type: Observational
• Actual Enrollment: 3 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Xen Implantation on the Aqueous Humor Proteome
• Actual Study Start Date: Oct 24, 2019
• Actual Primary Completion Date: Feb 15, 2022
• Actual Study Completion Date: Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Xen Patients treated with a Xen microstent for glaucoma.	Device: Xen; Xen microstent implantation
Aqueous shunt Patients treated with an aqueous shunt for glaucoma.	Device: Aqueous shunt; Aqueous shunt implantation

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Price Vision Group	Indianapolis	Indiana	United States	46260

Sponsors and Collaborators

• Price Vision Group

Investigators

• Principal Investigator: Francis Price, Jr, MD, Price Vision Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Price Vision Group
• ClinicalTrials.gov Identifier: NCT04141865
• Other Study ID Numbers: 2019-006
• First Posted: Oct 28, 2019
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Glaucoma, Open-Angle

Study Results

No Results Posted as of Mar 3, 2022