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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery), the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a surgery known as supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.
The Xen-45 gelatin microstent (Allergan, Dublin, Ireland) is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Creation of a filtering bleb through the gel stent and under the conjunctiva lowers intraocular pressure (IOP) by bypassing the natural outflow pathway of aqueous. A recent retrospective cohort study showed comparable safety and risk of failure to trabeculectomy. Amongst the main advantages of this device is the ability to create a bleb without dissecting and disrupting tissue, thus decreasing the amount of wound healing and potentially limiting bleb failure. However, despite demonstrating similar efficacy and safety to trabeculectomy,2 the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. Although antimetabolites, such as mitomycin C, have decreased reactionary wound healing that can result following surgery, fibrosis may still occur, especially when the components of the Xen-45 gelatin microstent are in close proximity to the fibroblastic structures of tenon's fascia.Tenon's capsule resembles a sponge-like layer with multiple adhesions to the overlying conjunctiva and underlying episclera. Implantation of the XEN within this space creates a higher risk of obstruction and subsequent failure. To ensure the lowest potential for occlusion, bleb scarring, and failure, one must ensure careful placement of the device in the subconjunctival space, avoiding intra-tenon's placement. Placement in the supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted supratenon's placement of XEN 45 | Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. |
| |
| Non-targeted placement of XEN 45 | Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XEN-45 gelatin microstent | Device | Placement either in the subconjunctival space or supratenon's area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications | Post op year 1 |
| Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications | Post op Year 1 |
| Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications | Post op year 1 |
| Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication | Post op Year 1 |
| Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications | Post op Year 1 |
| Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. | Presence or absence of the following complications: i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia. ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.
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| Name | Affiliation | Role |
|---|---|---|
| Iqbal Ike Ahmed, MD | Prism Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Eye Institute | Oakville | Ontario | L6H 0J8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28237137 | Background | Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17. | |
| 28601250 | Background | Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-targeted Placement of XEN 45 | Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area |
| FG001 | Targeted Supratenon's Placement of XEN 45 | Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-targeted Placement of XEN 45 | Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area |
| BG001 | Targeted Supratenon's Placement of XEN 45 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications | Per protocol population | Posted | Count of Participants | Participants | Post op year 1 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-targeted Placement of XEN 45 | Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronaldo Santiago | Prism Eye Institute | 905-456-3937 | 267 | ronaldo.santiago@prismeye.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2018 | Jul 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Post op year 1 |
| Post op year 1 |
| Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. | Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen. | Post op year 1 |
| 28751986 | Background | Fea AM, Spinetta R, Cannizzo PML, Consolandi G, Lavia C, Aragno V, Germinetti F, Rolle T. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent. J Ophthalmol. 2017;2017:9364910. doi: 10.1155/2017/9364910. Epub 2017 Jun 20. |
| 29053204 | Background | Sng CC, Wang J, Hau S, Htoon HM, Barton K. XEN-45 collagen implant for the treatment of uveitic glaucoma. Clin Exp Ophthalmol. 2018 May;46(4):339-345. doi: 10.1111/ceo.13087. Epub 2017 Nov 29. |
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetic | Count of Participants | Participants |
|
| Preoperative Best Corrected Visual Acuity (BCVA) | Median | Inter-Quartile Range | logMAR |
|
| Number of Patients who received XEN 45 in Left Eye | Count of Participants | Participants |
|
| IOP > 21 mmHg | Count of Participants | Participants |
|
| IOP median | Median | Inter-Quartile Range | mmHg |
|
| Medication Classes | Median | Inter-Quartile Range | Medication Classes |
|
| Primary Open Angle Glaucoma | Count of Participants | Participants |
|
| Pseudoexfoliation | Count of Participants | Participants |
|
| Pigment Dispersion Glaucoma | Count of Participants | Participants |
|
| Primary Angle Closure Glaucoma | Count of Participants | Participants |
|
| Combined Mechanism Glaucoma | Count of Participants | Participants |
|
| Cup to Disk Ratio | Median | Inter-Quartile Range | Ratio |
|
| Preoperative Mean Deviation on Visual Field to Normal Population | Median | Inter-Quartile Range | decibel |
|
| Mild Disease | 0 to >-6.0 dB mean deviation from normal in visual fields | Count of Participants | Participants |
|
| Moderate to Severe Disease | ≤-6.0 dB mean deviation from normal visual fields | Count of Participants | Participants |
|
| Laser Peripheral Iridotomy | Count of Participants | Participants |
|
| Laser Trabeculoplasty | Count of Participants | Participants |
|
| Concomitant Cataract Surgery | Count of Participants | Participants |
|
|
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| Primary | Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications | Per protocol population | Posted | Count of Participants | Participants | Post op Year 1 |
|
|
|
| Primary | Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications | Per protocol polulation | Posted | Count of Participants | Participants | Post op year 1 |
|
|
|
| Primary | Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication | per protocol population | Posted | Count of Participants | Participants | Post op Year 1 |
|
|
|
| Primary | Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications | per protocol population | Posted | Count of Participants | Participants | Post op Year 1 |
|
|
|
| Primary | Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6. | Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications | per protocol population | Posted | Count of Participants | Participants | Post op year 1 |
|
|
|
| Secondary | Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. | Presence or absence of the following complications: i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia. ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis | Per protocol population | Posted | Count of Participants | Participants | Post op year 1 |
|
|
|
| Secondary | Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. | Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen. | per protocol population | Posted | Count of Participants | Participants | Post op year 1 |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Targeted Supratenon's Placement of XEN 45 | Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area | 0 | 77 | 0 | 77 | 0 | 77 |
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