Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma

Mansouri, Kaweh; Gillmann, Kevin; Rao, Harsha L.; Guidotti, Jacopo; Mermoud, André

doi:10.1097/ijg.0000000000001045

Cited by 43 publications

(43 citation statements)

References 16 publications

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“…In two of the XEN ® 45-implantation procedures a dry-lake bleb reconversion [13] was performed, while none of the XEN ® 63 procedures required one. If we compare our outcomes with those published in the literature, in De Gregorio's [16] study, 2.4% of the patients required needling, while in Mansouri et al [15] as much as 36% of the open-angle glaucoma patients had to undergo needling. Such a low rate could be due in our case not only to the surgeon's experience as well as to the consistent application of subconjunctival mitomycin prior to the procedure.…”

Section: Discussionmentioning

confidence: 82%

“…Mansouri et al [15] also found a significant decrease of IOP although his study focused only on the first year of postimplantation follow-up, as did De Gregorio's et al [16], who reported in their study a 44% IOP drop. Moreover, it is worth pointing out that these two studies only assessed the XEN ® 45 Gel Stent and that Mansouri's included not only patients with POAG but also pseudoexfoliative glaucoma cases.…”

Section: Discussionmentioning

confidence: 89%

“…(83%, 81.8%, and 46.5%). Other authors [15][16][17] also observed a drop in the number of IOP-lowering medications being used although their findings are limited by their shortterm (one-year) postimplantation follow-up.…”

Section: Discussionmentioning

confidence: 96%

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Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Fernández-García¹,

Zhou²,

García-Alonso

et al. 2020

Journal of Ophthalmology

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Purpose. To evaluate medium-term clinical outcomes with XEN® 45 or XEN® 63 Gel Stent (Allergan, Dublin, Ireland) for treatment of primary open angle glaucoma (POAG). Materials and Methods. Retrospective, descriptive, and observational study involving 40 patients implanted with a XEN® 45 Gel Stent and 34 implanted with a XEN® 63 Gel Stent who had undergone POAG surgery and had been followed up and controlled between 12 and 36 months. Results. IOP dropped from 18.02 ± 5.23 mmHg preop to 13.81 ± 1.88, 14.80 ± 2.23, and 14.62 ± 1.90 at 1, 2, and 3 years after surgery (p<0.001) consecutively with XEN® 45 and from 19.00 ± 6.11 mmHg preop to 15.47 ± 2.45, 14.66 ± 2.45, and 15.46 ± 2.48 at 1, 2, and 3 years after surgery (p<0.001) with XEN® 63. The number of drugs used by patients to treat their glaucoma decreased after undergoing surgery in both groups. Within the XEN® 45 group, mean changes at 1 year, 2 years, and 3 years amounted to 70%, 74.3%, and 37.5%, respectively, whereas within the XEN® 63 group, the mean reduction was 75%, 79.8%, and 71.9%. When comparing the outcomes for two groups, the differences did not prove to be statistically significant. More than 90% of the procedures included in the study (using either gel-stent device) were completed without any noteworthy complications. Conclusion. POAG surgical procedures with either XEN® 45 or XEN® 63 Gel Stent implantation could be a safe and effective treatment approach.

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Section: Discussionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 89%

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Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Fernández-García¹,

Zhou²,

García-Alonso

et al. 2020

Journal of Ophthalmology

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“…Consistent with the American Academy of Ophthalmology's Preferred Practice Pattern Guidelines [1], needling was part of the standard postoperative care to improve aqueous flow and lower IOP based on the investigator's clinical assessment of bleb function. Consistent with other recent studies [18,19], needling was not considered an adverse event (AE) or glaucomarelated secondary surgical intervention (SSI) but was documented as a postoperative procedure; it could be performed at any point in the postoperative period, as believed necessary by the investigator. No specific protocol was mandated, and use of an antifibrotic agent at the time of needling was also left to the investigator's discretion.…”

Section: Perioperative Proceduresmentioning

confidence: 86%

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Reitsamer

Sng

Vera³

et al. 2019

Graefes Arch Clin Exp Ophthalmol

172

173

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Purpose To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary openangle glaucoma (POAG). Methods In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed. Results The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were − 6.5 (5.3) mmHg and − 1.7 (1.3) at month 12 and − 6.2 (4.9) mmHg and − 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts. Conclusions The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).

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“…Mansouri et al compared 57 eyes with POAG and 53 eyes with PXG and demonstrated equal efficacy and safety for both treatment groups. [21] The PXG eyes were noted to have a 31% IOP drop at 12 months and a 63% success rate as compared to 30% and 42%, respectively, for POAG eyes. In a study on 24 uveitic eyes, Sng et al noted a 60% IOP decline at post-operative month 12 with 83% eyes requiring no further glaucoma surgery.…”

Section: Intraocular Pressure Controlmentioning

confidence: 91%

XEN Gel stent: A Review

Dangda¹,

Castanos²,

Do³

et al. 2019

cleverjournal

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Over the last decade, several new surgical devices and treatment options have been developed for the management of glaucoma. Together, known as micro-invasive glaucoma surgery, they aim to provide a safer approach to glaucoma surgery. Although the early devices were used to either stent or ablate a segment of the trabecular meshwork, newer devices such as the XEN gel stent (Allergan Inc., Dublin, Ireland), offer the possibility of creating a safer, more predictable filtering bleb. Since its FDA approval in 2016, several retrospective case series and prospective studies have highlighted the efficacy of the XEN gel stent with regards IOP lowering and reduction in the need for glaucoma medications. The XEN gel stent has also been shown to have a favorable safety profile in terms of intraoperative and post-operative complications. The major concern is the need for bleb intervention in the form of needling and injection of anti-fibrotic agents. This review focuses to summarize the current knowledge on the XEN gel stent for treatment of various subtypes of glaucoma.

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Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma

Abstract: The XEN gel implant as a standalone or combined procedure demonstrated similar efficacy and safety results in PEXG and POAG eyes.

Cited by 43 publications

References 16 publications

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

XEN Gel stent: A Review

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