Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry

Oddone, Francesco; Roberti, Gloria; Giammaria, Sara; Posarelli, Chiara; Ghirelli, Giorgio; Mastropasqua, Leonardo; Agnifili, Luca; Ferrari, Tommaso Micelli; Pace, Vincenzo; Nucci, Paolo; Sacchi, Matteo; Monsellato, Gianluca; Altafini, Romeo; Scuderi, Gianluca; Perdicchi, Andrea; Uva, Maurizio G.; Carnevale, Carmela; Covello, Giuseppe; Maglionico, Maria Novella; Fea, Antonio Maria; Figus, Michele

doi:10.1038/s41433-023-02642-5

Cited by 4 publications

(8 citation statements)

References 47 publications

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“…HM is a relatively rare complication associated with XEN gel stent implantation that can occur within less than 1 week or more than 1 month, with a reported incidence of 1.9–4.6% ( 27 , 62 ) ( Figures 1C , D ). Macular hypotony is characterized by a decrease in visual acuity caused by macular folds, retinal edema, papilledema, and vascular tortuosity.…”

Section: Systematic Reviewmentioning

confidence: 99%

“…Bleb leakage is an uncommon but potentially sight-threatening complication of XEN gel stent implantation, with a reported incidence of 2.1% ( 62 ). Persistent conjunctival bleb leakage may cause over-infiltration and ocular hypotony, increasing the risk of infection, stent displacement, and endophthalmitis.…”

Section: Systematic Reviewmentioning

confidence: 99%

“…Ptosis is a relatively rare complication associated with XEN gel stent implantation, with a reported incidence of 1.2% ( 62 ). Some proposed mechanisms for the cause of ptosis after surgery include lid edema from locally administered anesthetic, initial myotoxic effects, and compression of the upper eyelid against the orbital bones from the eyelid speculum, which reduces blood flow to the levator muscle and contributes to the edema ( 110 , 111 ).…”

Section: Systematic Reviewmentioning

confidence: 99%

“…ME is a transient and generally benign condition associated with the combined therapy of XEN gel stent implantation and phacoemulsification. It has been reported to have an incidence of 1.5–4.3% ( 62 , 74 , 75 ). In a study that followed 261 eyes receiving XEN gel stent implantation with or without phacoemulsification for an average of 8.5 months, four cases of ME occurred.…”

Section: Systematic Reviewmentioning

confidence: 99%

“…All of these cases occurred in eyes receiving the combination therapy and resolved spontaneously without further treatment ( 75 ). Oddone et al reported seven cases of ME during a 12-month follow-up of 239 cases ( 62 ). The cause is believed to be post-phacoemulsification Irvine-Gass syndrome, but further studies are needed to confirm its cause and prognosis.…”

Section: Systematic Reviewmentioning

confidence: 99%

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Complications of XEN gel stent implantation for the treatment of glaucoma: a systematic review

Gan,

Wang,

Chen

et al. 2024

Front. Med.

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AimThis study was aimed to summarize the complications and their management associated with XEN gel stent implantation.MethodsA systematic review of literature was conducted using Medline (via PubMed), EMBASE, the Cochrane Library databases, and China National Knowledge Infrastructure, from their inception to February 1, 2024.ResultsA total of 48 studies published between 2017 and 2024 were identified and included in the systematic review, including 16 original studies (retrospective or prospective clinical studies), 28 case reports, and 4 case series, which followed patients for up to 5 years. Early postoperative complications of XEN gel stent implantation include hypotony maculopathy (1.9–4.6%), occlusion (3.9–8.8%), suprachoroidal hemorrhage (SCH), choroidal detachment (0–15%), conjunctival erosion, and exposure of the XEN gel stent (1.1–2.3%), wound and bleb leaks (2.1%) and malignant glaucoma (MG) (2.2%). Mid-postoperative complications of XEN gel stent implantation included migration of XEN (1.5%), ptosis (1.2%), endophthalmitis (0.4–3%), macular edema (1.5–4.3%), hypertrophic bleb (8.8%) and subconjunctival XEN gel stent fragmentation (reported in 2 cases). Late postoperative complications reported in cases included spontaneous dislocation and intraocular degradation.ConclusionXEN gel stent implantation is a minimally invasive glaucoma surgery (MIGS) procedure for glaucoma, known for its potential to minimize tissue damage and reduce surgical duration. However, it is crucial to note that despite these advantages, there remains a risk of severe complications, including endophthalmitis, SCH, and MG. Therefore, postoperative follow-up and early recognition of severe complications are essential for surgical management.

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Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

See 3 more Smart Citations

Complications of XEN gel stent implantation for the treatment of glaucoma: a systematic review

Gan,

Wang,

Chen

et al. 2024

Front. Med.

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Occlusion of Xen Gel Stent With Descemet’s Membrane Relieved by Nd:YAG Laser

Strong Caldwell,

Gill,

St. Peter

2024

Journal of Glaucoma

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The Xen gel stent is a minimally invasive glaucoma surgical implant designed to decrease intraocular pressure by creating an aqueous outflow path into the subconjunctival space. Since FDA approval, it has demonstrated good safety and efficacy data, however there are multiple reports of Xen stent occlusions with debris from the anterior chamber. Herein, we report a case of a Descemet’s membrane Xen stent occlusion in a 67-year-old woman with past medical history of primary open angle glaucoma who underwent Xen stent placement via the ab externo approach. Her Descemet’s membrane occlusion was successfully managed by Nd:YAG laser lysis. While uncommon, small Descemet’s tears or flaps can occlude the ostia of Xen stents causing elevated intraocular pressure or bleb failure. Few reports have described the use of Nd:YAG laser to successfully treat ostium occlusion of any kind with the Xen stent. We discuss the importance of early Nd:YAG laser to relieve Descemet’s membrane occlusions, lower intraocular pressure, and rescue the bleb from failure.

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XEN45 Implant in Medically Controlled vs. Uncontrolled Eyes—Differential IOP Changes in Real-Life Conditions

Julio,

Larena,

Mármol

et al. 2024

JCM

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Background: To assess intraocular pressure (IOP) changes and complications after XEN45 implants in medically controlled eyes (MCE) vs. medically uncontrolled eyes (MUE). Methods: A retrospective study, in a tertiary referral hospital, on mild-to-moderate primary open-angle glaucoma (POAG) cases under topical medication, including 32 eyes with IOP < 21 mmHg (MCE group) and 30 eyes with IOP ≥ 21 mmHg (MUE group). The success criteria using Kaplan–Meier analysis was IOP < 21 mmHg without medications (complete success) or fewer drugs than preoperatively (qualified success) at the last visit, without new surgery or unresolved hypotony. Results: No significant preoperative differences were found between the groups. The mean IOP was 15.6 ± 3.8 mmHg in MCE and 15.1 ± 4.1 mmHg in the MUE group (p > 0.05; Mann–Whitney test) at the end of the follow-up (mean of 26.1 ± 15.6 months and 28.3 ± 15.3 months, respectively) (p = 0.414, Mann–Whitney Test). The device caused a significant IOP reduction at 24 h in both groups. Thereafter, the MCE group significantly tended to increase IOP, recovering baseline values at 1 month and maintaining them until the end of the follow-up. In contrast, in the MUE group, the IOP values tended to be similar after the first reduction. No relevant complications and no significant differences between the groups in the survival analysis were found. Conclusions: XEN45 provided stable IOP control in both the MCE and MUE group without important complications in the medium term. The IOP increasing in the MCE group, after a prior decrease, led to restored baseline values 1 month after surgery. The homeostatic mechanism that causes the rise in the IOP to baseline values and its relationship with failure cases remains to be clarified.

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Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry

Cited by 4 publications

References 47 publications

Complications of XEN gel stent implantation for the treatment of glaucoma: a systematic review

Complications of XEN gel stent implantation for the treatment of glaucoma: a systematic review

Occlusion of Xen Gel Stent With Descemet’s Membrane Relieved by Nd:YAG Laser

XEN45 Implant in Medically Controlled vs. Uncontrolled Eyes—Differential IOP Changes in Real-Life Conditions

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