Dataset Information

A multi-centre interventional case series of 259 ab-interno Xen gel implants for glaucoma, with and without combined cataract surgery.

ABSTRACT:

Aims

To assess the efficacy of Xen in reducing intraocular pressure (IOP) in varying glaucoma subtypes. To assess the effect of combined phacoemulsification. To determine the frequency of complications and explore further bleb management needed.

Methods

Retrospective case note review of all patients undergoing Xen implantation across four centres from August 2015 to May 2017.

Results

In total, 259 consecutive surgeries of 226 patients were reviewed. IOP reduced from 19.3 (SD ± 6.0) mmHg preoperatively to 14.2 (SD ± 4.4) at month 12 and 13.5 (SD ± 3.3) at month 18 (p < 0.0001). Medication usage reduced from 2.6 (±1.1) preoperatively to 0.8 (±1.0) at month 12 (p < 0.0001) and 1.1 (±1.3) medications at month 18 (p < 0.0001). Simultaneous phacoemulsification did not alter outcomes as Xen IOP was 14.3 (SD ± 4.7) mmHg and Phaco-Xen was 13.8 (SD ± 2.6) mmHg at month 12 (p = 0.5367). Xen appears to be effective in previous failed filtration surgery. Adverse events included: IOP spikes of ≥30 mmHg in 33 (12.7%) cases, secondary filtration surgery required in 24 (9.3%) cases; implant exposure in 6 (2.3%) cases; persistent hypotonous maculopathy in 5 (1.9%) cases; persistent choroidal effusions in 4 (1.5%) cases; a cyclodialysis cleft secondary to implant insertion in 1 (0.5%) case; and 1 (0.5%) case of endophthalmitis post-implant bleb resuturing. In all, 40.9% of cases required postoperative bleb needling or antimetabolite injection.

Conclusions

Xen reduces IOP and medications at 18 months. Adverse events are uncommon. Careful postoperative surveillance and low threshold for bleb management is needed. Xen is safe and effective in mild to moderate glaucoma.

SUBMITTER: Karimi A

PROVIDER: S-EPMC6460711 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

A multi-centre interventional case series of 259 ab-interno Xen gel implants for glaucoma, with and without combined cataract surgery.

Karimi Ayesha A Lindfield Dan D Turnbull Andrew A Dimitriou Chrysostomos C Bhatia Bhairavi B Radwan Mahmoud M Gouws Pieter P Hanifudin Abdul A Amerasinghe Nishani N Jacob Aby A

Eye (London, England) 20181024 3

<h4>Aims</h4>To assess the efficacy of Xen in reducing intraocular pressure (IOP) in varying glaucoma subtypes. To assess the effect of combined phacoemulsification. To determine the frequency of complications and explore further bleb management needed.<h4>Methods</h4>Retrospective case note review of all patients undergoing Xen implantation across four centres from August 2015 to May 2017.<h4>Results</h4>In total, 259 consecutive surgeries of 226 patients were reviewed. IOP reduced from 19.3 (S ...[more]

PMID: 30356133

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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: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.

Dataset Information

A multi-centre interventional case series of 259 ab-interno Xen gel implants for glaucoma, with and without combined cataract surgery.

Aims

Methods

Results

Conclusions

Publications

A multi-centre interventional case series of 259 ab-interno Xen gel implants for glaucoma, with and without combined cataract surgery.

Similar Datasets

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