Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)

XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)

A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: XEN Group; Procedure: Phacoemulsification

• Study Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92622
      • Clinical Trials Registry Team

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participant eyes that underwent XEN 45 Gel Stent implantation from 1 January 2014 until 1 October 2015.

Description

Inclusion Criteria:

• Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
• XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015

Exclusion Criteria

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Implant; Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.	Device: XEN Group; Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015.
Implant + Phaco; Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.	Procedure: Phacoemulsification; Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation	IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.	Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation	IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.	Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean IOP to 48 Months After Implantation	IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.	Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation	IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.	Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Percentage of Eyes Achieving Qualified Success at Month 36	Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline.	Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Percentage of Eyes Achieving Qualified Success at Month 48	Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline.	Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Percentage of Eyes Achieving Complete Success at Month 36	Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications.	Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Percentage of Eyes Achieving Complete Success at Month 48	Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications.	Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Percentage of Eyes With Adverse Events of Special Interest (AESIs)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a drug whether or not it is considered related to drug. AESI include: Glaucoma, defined as damage to optic nerve with progressive vision loss, Intraocular hypertension, defined as IOP without meeting criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation. Data of AESIs are presented based on eyes for this outcome measure.	Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Mini Balaram, MD, Allergan

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2019
• Primary Completion (ACTUAL): October 25, 2019
• Study Completion (ACTUAL): October 25, 2019

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: CMO-MA-EYE-0590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO