Glaucoma
Conditions
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.
Interventions
DEVICEXEN 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.
PROCEDUREPhacoemulsification
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.
Sponsors
Allergan
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| 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. | 98 |
| 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. | 76 |
| 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. | 76 |
| Total | 348 |
Baseline characteristics
| Characteristic | Implant + Phaco | Total | Implant |
|---|---|---|---|
| Age, Continuous | 75.95 years STANDARD_DEVIATION 7.107 | 72.26 years STANDARD_DEVIATION 10.764 | 69.40 years STANDARD_DEVIATION 12.193 |
| Race/Ethnicity, Customized Asian | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Latin American | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White, Caucasian | 75 Participants | 166 Participants | 91 Participants |
| Sex: Female, Male Female | 39 Participants | 91 Participants | 52 Participants |
| Sex: Female, Male Male | 37 Participants | 83 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 76 |
| other Total, other adverse events | 0 / 98 | 0 / 76 |
| serious Total, serious adverse events | 2 / 98 | 0 / 76 |
Outcome results
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
Population: Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implant | Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation | Baseline | 21.03 mm Hg | Standard Deviation 4.638 |
| Implant | Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation | Change from Baseline to Month 36 | -6.42 mm Hg | Standard Deviation 5.655 |
| Implant + Phaco | Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation | Baseline | 20.21 mm Hg | Standard Deviation 5.64 |
| Implant + Phaco | Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation | Change from Baseline to Month 36 | -6.73 mm Hg | Standard Deviation 7.62 |
p-value: <0.0001Paired t-test
p-value: <0.0001Paired t-test
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
Population: Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implant | Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation | Baseline | 2.6 medications | Standard Deviation 0.98 |
| Implant | Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation | Change from Baseline to Month 36 | -1.6 medications | Standard Deviation 1.49 |
| Implant + Phaco | Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation | Baseline | 2.4 medications | Standard Deviation 1.02 |
| Implant + Phaco | Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation | Change from Baseline to Month 36 | -1.2 medications | Standard Deviation 1.52 |
p-value: <0.0001Paired t-test
p-value: 0.0001Paired t-test
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Population: Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implant | Change From Baseline in Mean IOP to 48 Months After Implantation | Baseline | 21.03 mm Hg | Standard Deviation 4.638 |
| Implant | Change From Baseline in Mean IOP to 48 Months After Implantation | Change from Baseline to Month 48 | -5.46 mm Hg | Standard Deviation 4.998 |
| Implant + Phaco | Change From Baseline in Mean IOP to 48 Months After Implantation | Baseline | 20.21 mm Hg | Standard Deviation 5.64 |
| Implant + Phaco | Change From Baseline in Mean IOP to 48 Months After Implantation | Change from Baseline to Month 48 | -5.27 mm Hg | Standard Deviation 5.298 |
p-value: 0.003Paired t-test
p-value: 0.0018Paired t-test
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Population: Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implant | Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation | Baseline | 2.6 medications | Standard Deviation 0.98 |
| Implant | Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation | Change from Baseline to Month 48 | -1.1 medications | Standard Deviation 1.08 |
| Implant + Phaco | Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation | Baseline | 2.4 medications | Standard Deviation 1.02 |
| Implant + Phaco | Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation | Change from Baseline to Month 48 | -0.8 medications | Standard Deviation 1.42 |
p-value: 0.0053Paired t-test
p-value: 0.0472Paired t-test
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Population: Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implant | Percentage of Eyes Achieving Complete Success at Month 36 | 45.7 percentage of eyes |
| Implant + Phaco | Percentage of Eyes Achieving Complete Success at Month 36 | 20.0 percentage of eyes |
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Population: Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implant | Percentage of Eyes Achieving Complete Success at Month 48 | 33.3 percentage of eyes |
| Implant + Phaco | Percentage of Eyes Achieving Complete Success at Month 48 | 20.0 percentage of eyes |
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Population: Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implant | Percentage of Eyes Achieving Qualified Success at Month 36 | 23.9 percentage of eyes |
| Implant + Phaco | Percentage of Eyes Achieving Qualified Success at Month 36 | 40.0 percentage of eyes |
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Population: Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implant | Percentage of Eyes Achieving Qualified Success at Month 48 | 25.0 percentage of eyes |
| Implant + Phaco | Percentage of Eyes Achieving Qualified Success at Month 48 | 33.3 percentage of eyes |
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.
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months
Population: Safety Population consisted of all eligible participant eyes in the study population. For participants implanted bilaterally, both eyes were included for analysis if both met the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implant | Percentage of Eyes With Adverse Events of Special Interest (AESIs) | 18.1 percentage of eyes |
| Implant + Phaco | Percentage of Eyes With Adverse Events of Special Interest (AESIs) | 10.4 percentage of eyes |