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Completed

NCT Number: NCT03868254

Chart Review of 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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Trials Registry Team

Irvine, California, 92622, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XEN Group

Device

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.

phacoemulsification

Procedure

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.

Primary outcomes

  1. Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation

    Time frame: 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.

  2. Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in Mean IOP to 48 Months After Implantation

    Time frame: 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.

  2. Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation

    Time frame: 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.

  3. Percentage of Eyes Achieving Qualified Success at Month 36

    Time frame: 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.

  4. Percentage of Eyes Achieving Qualified Success at Month 48

    Time frame: 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.

  5. Percentage of Eyes Achieving Complete Success at Month 36

    Time frame: 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.

  6. Percentage of Eyes Achieving Complete Success at Month 48

    Time frame: 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.

  7. Percentage of Eyes With Adverse Events of Special Interest (AESIs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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