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.
Study Type
OBSERVATIONAL
Enrollment
142
Placement either in the subconjunctival space or supratenon's area
Prism Eye Institute
Oakville, Ontario, Canada
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post op year 1
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
Time frame: 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.
Time frame: Post op year 1
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