XEN gel implant with or without phacoemulsification for glaucoma: a systematic review and meta-analysis

BACKGROUND: XEN 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. METHODS: The 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. RESULTS: Twelve 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, I(2)=60%) and reduced the number of IOP lowering drugs (SMD 0.01, 95% CI, –0.16 to 0.17, I(2)=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, I(2)=38%) and reducing the number of medications (729 eyes, SMD 0.20, 95% CI, –0.06 to 0.46, I(2)=62%). CONCLUSIONS: XEN 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.