Cutting the subconjunctival fragment of the XEN gel implant during needling procedure

Bustros, Youssef; Chaudhary, Ankita; Salinas, Lauriane; Mansouri, Kaweh

doi:10.1177/1120672118805876

Cited by 11 publications

(9 citation statements)

References 8 publications

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“…Rarer adverse events were IOP spike, occlusion of the stent lumen, reduction in best correct visual acuity, XEN exposure, choroidal effusion, and endophthalmitis. 14,16,19,36,37 In our study, we encountered similar rates of hypotony compared with previous studies but more cases of hyphema. 16,19 Compared with the XEN gel stent, the PRESERFLO microshunt seems to have lower rates of needling and bleb revision, varying between 6.2% and 23% compared with the average 30%-50% range reported in the literature for the XEN.…”

Section: Discussionsupporting

confidence: 85%

XEN 45 Gel Stent Implantation in Open Angle Glaucoma: 5-Year Results of a Prospective Study

Torbey,

Paillard,

Rao

et al. 2023

Journal of Glaucoma

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Precis: XEN 45 Gel Stent is safe and effective for 3 years. The study results provide useful insight into the outcome of XEN 45 Gel Stent surgery over 5 years in daily clinical practice. Purpose: To evaluate 5-year outcomes of XEN 45 gel stent implantation (XEN) in patients with open-angle glaucoma. Patients and Methods: This is a prospective, single-center, interventional study. XEN implantation either alone (XEN) or combined with phacoemulsification (Phaco + XEN) was performed on 170 consecutive eyes (126 patients) with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. ‘Complete’ surgical success at 60 months was defined as unmedicated IOP ≤15 mmHg and a relative IOP reduction ≥ 20% from medicated baseline, while ‘qualified’ success allowed fewer ocular hypotensive medications (OHM) than at baseline. Other definitions of success with various IOP targets were also analyzed. Secondary outcomes included mean IOP and IOP lowering medication changes, and rates of re-operations. Results: Mean age was 78.1±9.2 years and 70.3% were female. Mean medicated IOP decreased from 19.8±7.7 mmHg (19.6±7.1 [XEN] vs. 19.8±7.0 mmHg [Phaco+XEN]) at baseline to 12.6±3.1 mmHg (12.5± 3.1 [XEN] vs. 12.6±3.1 [Phaco+XEN]) at 5 years (−37.0%; P < 0.001). Medications decreased from 2.0±1.3 (2.0±1.3 [XEN] vs. 2.0±1.3 [Phaco+XEN]) to 0.8±1.1 (0.8±1.1 [XEN] vs. 0.8±1.1 [Phaco + XEN]) (−60%; P<0.001). Needling was performed in 84 eyes (49%), and 19.4% underwent a secondary surgical intervention. Complete success at 3 years was a strong predictor of success at 5 years (OR:3.06, P<0.01), while needling was associated with higher rates of failure (OR:3.6, P<0.01). Conclusion: At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction. Success at 3 years is a predictor of success at 5 years. Needling correlates with higher failure rates.

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Section: Discussionsupporting

confidence: 85%

XEN 45 Gel Stent Implantation in Open Angle Glaucoma: 5-Year Results of a Prospective Study

Torbey,

Paillard,

Rao

et al. 2023

Journal of Glaucoma

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“…These were encouraging as shortening of the device should theoretically decrease resistance and increase flow rate, according to the Poiseuille's equation. Bustros et al 44 illustrated a similar case in which the view was obstructed at the time of needling due to subconjunctival heme. At the end of the procedure a fragment of Xen (1.1 mm in length) was found under the conjunctiva.…”

Section: Efficacy and Safety Of Needling Revisionmentioning

confidence: 97%

<p>XEN<sup>®</sup> Gel Stent: A Comprehensive Review on Its Use as a Treatment Option for Refractory Glaucoma</p>

Fea¹,

Durr²,

Marolo³

et al. 2020

OPTH

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The XEN Gel Microstent is a subconjunctival microinvasive glaucoma surgical device developed with the aim of improving the predictability and safety profile of blebforming glaucoma surgical procedures. The stent is a hydrophilic tube composed of a porcine gel cross-linked with glutaraldehyde with good stability and biocompatibility with minimal tissue reaction. This device has demonstrated promising outcomes with fewer risks compared to traditional surgeries. The aim of the review is to present early studies on different designs of the XEN Gel Stent, to summarize different surgical techniques of implantation and to analyze more comprehensively the results, complications and rates of needling of the commercially available device (Xen 45). The review will address separately special cases (PXG, UVG, ICE, congenital glaucoma) and describe small series and case reports.

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“…As bleb needling may damage the stent [11,12], a less invasive option than needling or surgical revision is needed for postoperative management. 5-Fluorouracil is a pyrimidine analogue and an antimetabolite used widely in oncology.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation

et al. 2019

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Purpose To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation. Methods Prospective real-world evidence study included 39 eyes (of 36 patients) with primary openangle glaucoma without previous glaucoma surgery and with uncontrolled intraocular pressure (IOP), glaucoma progression, or intolerance to IOP-lowering therapy. Patients underwent mitomycin C-augmented XEN implantation either as a stand-alone procedure or combined with cataract extraction. 5-Fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria (analogous to pro re nata regimen in age-related macular degeneration treatment). Primary outcome was unqualified success, defined as postoperative IOP \ 18 mmHg and[ 20% reduction from medicated baseline without any antiglaucoma medications and no detected glaucoma progression. Results At median follow-up of 8 months (range 3-24 months), IOP decreased from a medicated baseline value of 23 mmHg (95% CI 21-24 mmHg) to 13 mmHg (95% CI 12-15 mmHg) and number of medications decreased from 3 (95% CI 2-3) to 0 (p \ 0.0001 for both). Median number of 5-fluorouracil injections per eye was 3 (95% CI 2-3), and median time to first injection was 0.5 months (95% CI 0.25-3 months) after surgery. Thirteen eyes (33.3%) underwent C 1 needling, and surgical revision was performed in three cases (7.7%). The primary outcome measure, which allows performing additional procedures, was achieved in 27 eyes (69%). Conclusions 5-Fluorouracil subconjunctival injections are safe and effective in postoperative management of bleb failure after XEN implantation and represent a viable alternative to other methods.

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Cutting the subconjunctival fragment of the XEN gel implant during needling procedure

Cited by 11 publications

References 8 publications

XEN 45 Gel Stent Implantation in Open Angle Glaucoma: 5-Year Results of a Prospective Study

XEN 45 Gel Stent Implantation in Open Angle Glaucoma: 5-Year Results of a Prospective Study

<p>XEN<sup>®</sup> Gel Stent: A Comprehensive Review on Its Use as a Treatment Option for Refractory Glaucoma</p>

Efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation

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