Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
- Conditions
- Glaucoma
- Interventions
- Device: XEN GroupProcedure: Phacoemulsification
- Registration Number
- NCT03868254
- Lead Sponsor
- Allergan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Implant 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. 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. Implant + Phaco 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. 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.
Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.
Change From Baseline in Mean IOP to 48 Months After Implantation Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Percentage of Eyes Achieving Qualified Success at Month 36 Baseline (Day decision was made to implant XEN 45 Gel Stent), 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.
Percentage of Eyes Achieving Qualified Success at Month 48 Baseline (Day decision was made to implant XEN 45 Gel Stent), 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.
Percentage of Eyes With Adverse Events of Special Interest (AESIs) Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months 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.
Percentage of Eyes Achieving Complete Success at Month 36 Baseline (Day decision was made to implant XEN 45 Gel Stent), 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.
Percentage of Eyes Achieving Complete Success at Month 48 Baseline (Day decision was made to implant XEN 45 Gel Stent), 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.
Trial Locations
- Locations (1)
Clinical Trials Registry Team
🇺🇸Irvine, California, United States