XEN‐45 collagen implant for the treatment of uveitic glaucoma

Sng, Chelvin C. A.; Wang, Jing; Hau, Scott; Htoon, Hla Myint; Barton, Keith

doi:10.1111/ceo.13087

Cited by 66 publications

(32 citation statements)

References 33 publications

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“…Success was defined by eyes achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention (SSI) or intention to be converted to another procedure. mITT, modified intent-to-treat; phaco, phacoemulsification with intraocular lens replacement studies with this device, including the US pivotal trial in refractory glaucoma [23], as well as independent, retrospective [14,17,18,[24][25][26] and prospective [12,13,15,16,19,[27][28][29] studies in glaucoma, showing effectiveness at 1 year. Among those, a prospective, open-label study of the implant used alone or in combination with cataract surgery (N = 149 eyes) [16] showed that the mean medicated IOP and mean number of medications decreased from 20.0 (7.1) mmHg and 1.9 (1.3) at baseline to 13.9 (4.3) mmHg (P < 0.01) and 0.5 (0.8) (P < 0.001) at 1 year, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…Results from studies demonstrating the IOP-lowering performance and safety of the gelatin implant at 1 year across a spectrum of glaucoma patients have been published [12][13][14][15][16][17]. The present study was designed to evaluate, over 2 years in typical clinical settings, the effectiveness of the gelatin implant as primary surgical intervention in reducing IOP and the number of topical IOP-lowering medications in patients with POAG uncontrolled on topical therapy.…”

Section: Introductionmentioning

confidence: 99%

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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

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166

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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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Self Cite

166

173

View full text Add to dashboard Cite

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“…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. [23] To summarize, the XEN gel stent has shown early favorable data. However, as with other filtering procedures, the true question remains whether or not these blebs will stand the test of time.…”

Section: Intraocular Pressure Controlmentioning

confidence: 98%

“…[28] In uveitic eyes, Sng et al noted a bleb needling rate of 42% (performed at the slit-lamp) within the first 12 months of surgery, while 21% eyes underwent bleb revision in the operating room with dissection of the Tenon's layer within the first 4 months after XEN gel stent implantation. [23] In a study to assess the predictors of needling post-XEN gel stent implantation, Midha et al reported that eyes with lower IOP on day 1 were less likely to require a needling procedure and that a significant association was seen between lower day 1 IOP and lesser number of post-operative needling procedures. [29] The probability of needling was up to 80% in patients having a postoperative day 1 IOP >20 mm Hg while this number decreased to 35% if the day 1 IOP was <10 mm Hg.…”

Section: Bleb Revision/needlingmentioning

confidence: 99%

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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“…When placed correctly via an ab interno approach, the stent shunts aqueous from the anterior chamber (AC) to the subconjunctival and sub‐Tenon’s spaces. The use of the XEN45 Gel Stent is becoming more widespread, being predominantly used for cases of primary open angle glaucoma but also for the treatment of uveitic and refractory glaucoma …”

mentioning

confidence: 99%