Effect of Xen Implantation on the Aqueous Humor Proteome

NCT04141865 | Terminated FDA Device

• 1 other identifier: 2019-006
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Xen DEVICE

Xen microstent implantation

Xen

Aqueous shunt DEVICE

Aqueous shunt implantation

Aqueous shunt

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Price Vision Group: lead

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Glaucoma Drainage Implants

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Francis Price, Jr, MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: October 24, 2019
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)