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Efficacy of the XEN-Implant in Glaucoma and a Meta-Analysis of the Literature.

ABSTRACT: To assess the efficacy of XEN-implant surgery in patients with glaucoma, and to perform a meta-analysis of previously published results and compare these to our data. Prospective case-control study, in which all eyes that underwent XEN-implant surgery were included from 2015 onwards. Sub-analyses were performed for eyes that underwent XEN-implant as standalone procedure and as cataract-combined procedure. To compare our results, a systematic review was performed using the Embase, PubMed, Web of Science, and Cochrane database. Meta-analyses were performed by combining data (intraocular pressure (IOP), IOP-lowering medication, and complications) from the retrieved studies. A total of 221 eyes underwent XEN-implant surgery (124 standalone and 97 cataract-combined). The mean ± standard deviation IOP declined from 18.8 ± 6.5 to 13.5 ± 4.3 mmHg at the last follow-up (p < 0.001; 28.9%). Postoperative, no significant differences in IOP or IOP-lowering medication were found between patients with and without combined procedure. Secondary surgeries were performed in 20.8% of eyes, most of them (63.0%) within six months. A meta-analysis of 19 studies retrieved from the systematic review showed a two-years postoperative pooled mean (weighted mean difference) of 14.5 (7.3) mmHg and 1.0 (1.6) for IOP and IOP-lowering medications, respectively (compared to 13.5 (5.3) mmHg and 3.2 (2.4) in the current study). XEN-implant surgery was effective and safe in lowering IOP and the number of IOP-lowering medications. There were no differences between standalone and combined procedures.

SUBMITTER: Poelman HJ

PROVIDER: S-EPMC7962186 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Efficacy of the XEN-Implant in Glaucoma and a Meta-Analysis of the Literature.

Poelman Huub J HJ Pals Jan J Rostamzad Parinaz P Bramer Wichor M WM Wolfs Roger C W RCW Ramdas Wishal D WD

Journal of clinical medicine 20210307 5

<h4>Background</h4>To assess the efficacy of XEN-implant surgery in patients with glaucoma, and to perform a meta-analysis of previously published results and compare these to our data.<h4>Methods</h4>Prospective case-control study, in which all eyes that underwent XEN-implant surgery were included from 2015 onwards. Sub-analyses were performed for eyes that underwent XEN-implant as standalone procedure and as cataract-combined procedure. To compare our results, a systematic review was performed ...[more]

PMID: 33800112

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Project description:BackgroundXEN gel implant is an alternative method of treating glaucoma by connecting the anterior chamber and the subconjunctival space. The efficacy of the XEN gel implant and whether to combine with phacoemulsification is what most concerned. This review aims to test the efficacy and safety of the XEN gel implant compared with trabeculectomy and to test the efficacy between XEN combined with phacoemulsification and XEN alone.MethodsThe PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were searched through July 8, 2020. Studies comparing XEN and trabeculectomy or comparing XEN + phacoemulsification and XEN alone were included. The standard mean differences (SMD) were calculated to analyze the lowered intraocular pressure (IOP) and the number of anti-glaucoma medications. All data were measured from baseline to endpoint. The I2 statistic quantified heterogeneity ranged from 0% to 100%, and a random effects model was used in this meta-analysis. Review Manager 5.3 performed all analyses. The t-test calculated all P values, and P values were regarded as statistically significant at P<0.05. The methodological index for non-randomized studies was used to find and test bias in the literature.ResultsTwelve studies with 1,602 eyes were included. Five studies compared the XEN gel implant with trabeculectomy. Eight compared XEN + phacoemulsification with XEN alone. There was no significant correlation between XEN and trabeculectomy groups in lowering IOP (SMD 0.30, 95% CI, 0.00 to 0.60, I2=60%) and reduced the number of IOP lowering drugs (SMD 0.01, 95% CI, -0.16 to 0.17, I2=0%). There was a significant difference between XEN + phacoemulsification and XEN alone in lowering IOP (1,034 eyes, SMD 0.22, 95% CI, 0.05 to 0.40, I2=38%) and reducing the number of medications (729 eyes, SMD 0.20, 95% CI, -0.06 to 0.46, I2=62%).ConclusionsXEN gel implant, although not effective as trabeculectomy, is a safe operation for open-angle and some other types of glaucoma. Meanwhile, XEN alone is more effective than XEN combined with phacoemulsification within 1 week after operations. After three months, the two groups are similar in lowering IOP. More extensive, better-designed, strictly blinded, multicenter randomized clinical trials are needed to confirm our findings.

Project description:BackgroundXen is a device for minimally invasive glaucoma surgery, and is used to treat POAG, pseudoexfoliative or pigmentary glaucoma, as well as refractory glaucoma. The efficacy of XEN in treating glaucoma remains to be confirmed and clarified. Hence, we conducted a systematic review and meta-analysis to examine the efficacy and associated complication of XEN implantations.MethodsWe conducted a literature search in PubMed, EMBASE, the Cochrane Library of Systematic Reviews, Web of Science, China National Knowledge Infrastructure, WanFang and SinoMed databases to identify studies, published before May 15, 2021, which evaluated XEN in glaucoma, and parameters for measurements included intra-ocular pressure (IOP), number of anti-glaucoma medications (NOAM), and bleb needling rate. We compared the measurements of XEN-only procedure between phaco-XEN and trabeculectomy, and we also did sub-analysis based on time points, glaucoma types, ethnics, etc. Sensitivity analyses and publication bias were conducted for evaluating bias.This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA 2020) reporting guideline.ResultsWe identified 78 eligible studies, analysis revealed obvious IOP reduction after XEN stent implantation (SMD: 1.69, 95% CI 1.52 to 1.86, p value < 0.001) and NOAM reduction (SMD: 2.11, 95% CI 1.84 to 2.38, p value < 0.001). Sub-analysis showed no significant difference with respect to time points, ethnicities, and economic status. No significant difference was found between XEN treatment effect on POAG and PEXG eyes and between pseudo-phakic and phakic eyes. Also no significant difference was found between XEN and phaco-XEN surgery in terms of IOP after surgery (SMD: -0.01, 95% CI -0.09 to 0.08, p value 0.894). However, NOAM (after publication bias correction) and bleb needling rate (RR: 1.45, 95% CI 1.06to 1.99, p value 0.019) were lower in phaco-XEN group compared to XEN only group. Compared to trabeculectomy, XEN implantation had similar after-surgery IOP, however bleb needling rate (RR: 2.42, 95% CI 1.33 to 4.43, p value 0.004) was higher.ConclusionOur results confirmed that XEN is effective in lowering both IOP and NOAM till 48 months after surgery. It is noteworthy that XEN implantation leads to higher needling rate, compared to phaco-XEN or trabeculectomy. Further research, studying complications of XEN on non-European ethnicities, especially on Asian, are in urgent need before XEN is widely applied.

Project description:PurposeThe aim of this study was to evaluate the efficacy and safety of the Ahmed glaucoma valve in pediatric patients with refractory glaucoma.MethodsA comprehensive literature search was conducted across multiple major databases, including PubMed, Embase, the Cochrane Library of Systematic Reviews, Science Direct, China's National Knowledge Infrastructure, and the Wanfang database. We retrieved studies published before December 2022 that met the inclusion criteria, including clinical controlled trials (randomized controlled trials) and clinical noncontrolled trials (non-randomized controlled trials) on the use of Ahmed glaucoma valve in pediatric patients with refractory glaucoma. We performed a meta-analysis and systematic review. The efficacy measures included intraocular pressure, number of anti-glaucoma medications, visual acuity, and success rate. The safety measures were complications. Statistical analysis was performed using RevMan 5.0 software.ResultsWe identified 46 eligible studies: Compared with geographic location and study type, the Ahmed glaucoma valve showed a decrease in postoperative intraocular pressure and number of anti-glaucoma medications compared to preoperative levels in children with refractory glaucoma (P < 0.001). Compared with etiological, the Ahmed glaucoma valve showed a decrease in intraocular pressure after surgery compared to preoperative levels in children with refractory glaucoma (SMD: 14.57, 95% CI: 14.05-15.08, P < 0.00 1), and a decrease in postoperative number of anti-glaucoma medications compared to preoperative number of anti-glaucoma medications (SMD: 1.45, 95% CI: 1.37-1.54, P < 0.001). Compared with trabeculectomy revision surgery, there was no significant difference in the complete success rate between the two groups (SMD: 0.86, 95% CI: 0.52-1.39; P = 0.37).Overall, the postoperative intraocular pressure at the time of Ahmed glaucoma valve implantation was lower than that at the time of trabeculectomy revision surgery (SMD: 1.01, 95% CI: 0.71-1.31, I2 = 99%, P < 0.001). Subgroup analyses based on whether mitomycin C was use d or not. There was a statistically significant difference in intraocular pressure between Ahmed's glaucoma valve surgery and preoperative (SMD: 14.13, 95% CI: 13.47-14.80, P = 0.007). Comparison of cumulative complete success rates of Ahmed S2, S3, and Ahmed FP7, FP8 in Ahmed glaucoma valve surgery (SMD: 0.74, 95% CI: 0.38-1.45, I2 = 85%, P = 0.38). There is no statistical difference between the two groups. Choroidal effusion and anterior chamber hemorrhage are the two most common adverse events after Ahmed's glaucoma valve surgery.ConclusionsThe Ahmed glaucoma valve implantation has some effectiveness in reducing intraocular pressure in children with refractory glaucoma, but there are still many complications. Valve model may not be the key factor affecting the postoperative effectiveness and adverse reactions of refractory glaucoma in children.

Dataset Information

Efficacy of the XEN-Implant in Glaucoma and a Meta-Analysis of the Literature.

Publications

Efficacy of the XEN-Implant in Glaucoma and a Meta-Analysis of the Literature.

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