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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868254
• Other study ID #: CMO-MA-EYE-0590
• Status: Completed
• Start date: April 5, 2019
• Est. completion date: October 25, 2019

Study information

• Verified date: October 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Clinical Trials Registry Team	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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