飞秒激光辅助超乳白内障吸除联合MFIOL植入术疗效和安全性的Meta分析

Meta-analysis of the efficacy and safety of femtosecond laser-assisted phacoemulsification combined with MFIOL implantation

摘要:

目的：采用Meta分析的方法系统评价飞秒激光辅助超声乳化白内障吸除(FLACS)联合多焦点人工晶状体(MFIOL)植入术疗效和安全性。

方法：利用计算机检索PubMed、EMbase、Cochrane及OVID等数据库检索中英文文献，根据纳入和排除标准进行筛选，将FLACS联合MFIOL植入者列为观察组(FLACS-MFIOL)，传统超声乳化白内障吸除(CP)联合MFIOL植入者列为对照组(CP-MFIOL)。采用Cohrane系统评价的方法，由两名评价员独立地收集数据和质量评估； Review Manager 5.4软件对术后视力、等效球镜度(SE)、人工晶状体拟调节力、术中累积乳化能量(CDE)和角膜内皮密度(ECD)等五项指标进行Meta分析。STATA 14软件进行敏感性和发表偏倚分析。

结果：本研究根据纳入和排除标准筛选出10篇文献(其中1篇包含两组对比数据)，其中6篇为随机对照研究(RCT)研究，4篇为回顾性队列研究，共计1 045眼。Meta分析结果显示FLACS-MFIOL和CP-MFIOL组间术后1d，1wk，1、3mo，1a随访时间内UDVA无差异\〖(均数差s)：-0.02，95%可信区间(CI)-0.05，0.01，P=0.13； s：-0.01，95%CI -0.03，0.01，P=0.24； s：-0.03，95%CI -0.06，0.00，P=0.05； s：-0.03，95%CI -0.14，0.08，P=0.59； s：-0.03，95%CI -0.06，0.00，P=0.10\〗。UNVA在随访1d，1wk，3mo，1a时间内二组间无差异(s：0.04，95%CI -0.04，0.12，P=0.30； s：0.04，95%CI -0.06，0.13，P=0.47； s：0.00，95%CI -0.04，0.04，P=0.97； s：0.03，95%CI -0.06，0.12，P=0.54)，但术后1mo二组间UNVA有差异(s：0.03，95%CI 0.00，0.06，P=0.04)。FLACS-MFIOL和CP-MFIOL组间术后SE间无差异(s：0.06，95%CI -0.02，0.15，P=0.14)，但FLACS-MFIOL组人工晶状体视远和视近拟调节力要明显优于CP-MFIOL组(s：0.57，95%CI 0.42，0.72，P<0.001； s：1.32，95%CI 0.99，1.64，P<0.001)。FLACS-MFIOL组无论在Ⅱ和Ⅲ级晶状体核的患者，术中CDE较CP-MFIOL组均明显减少(s：-1.94，95%CI -2.59，-1.30，P<0.01； s：-3.81，95%CI -5.66，-1.96，P<0.01)，而FLACS-MFIOL组术后ECD损伤也明显小于对照组(s：111.75，95%CI 86.27，137.23，P<0.01)。采用逐一剔除法进行敏感性分析和发表偏倚发现本Meta分析结果稳定性较好，无明显发表偏倚。

结论：飞秒激光辅助白内障术中联合多焦点人工晶状体植入术式，能使患者获得优质视觉质量和拟调节力，同时大幅减少术中超声乳化能量对于正常眼内结构损伤，保护角膜内皮。

Abstract:

AIM:To systematically assess the efficacy and safety of femtosecond laser-assisted cataract surgery(FLACS)implanted with multifocal intraocular lens(MFIOL)with conventional cataract surgery.

METHODS: Electronic databases of PubMed, EMbase, Cochrane and OVID were searched for studies comparing FLACS-MFIOL and CP-MFIOL. Two independent reviewers performed the data extraction and analyzed. Visual acuity, spherical equivalent(SE), pseudophakic accommodation, cumulative dissipated energy(CDE)and endothelial cell density(ECD)were measured by Review Manager 5.4. Sensitivity and reporting bias were determined through the STATA 14 software.

RESULTS: From 106 screened articles, 1 045 eyes from 6 randomized controlled trials(RCTs)and 5 retrospective cohort studies were included(one of which contained two groups of comparative data). There was no evidence for any important differences in uncorrected distance visual acuity(UDVA)between FLACS-MFIOL and CP-MFIOL group after 1d, 1wk, 1, 3mo and 1a \〖s: -0.02, 95% Confidence Interval(CI)(-0.05, 0.01), P=0.13; s: -0.01, 95% CI(-0.03, 0.01), P=0.24; s: -0.03, 95% CI(-0.06, 0.00), P=0.05; s: -0.03, 95% CI(-0.14, 0.08), P=0.59; s: -0.03, 95% CI(-0.06, 0.00), P=0.10\〗. We found little evidence of any important difference in uncorrected near visual acuity(UNVA)between the two groups after 1d, 1wk, 3mo and 1a \〖s: 0.04, 95% CI(-0.04, 0.12), P=0.30; s: 0.04, 95% CI(-0.06, 0.13), P=0.47; s: 0.00, 95% CI(-0.04, 0.04), P=0.97; s: 0.03, 95% CI(-0.06, 0.12), P=0.54\〗. There was a small advantage in favor of FLACS-MFIOL over CP-MFIOL for UNVA after 1mo \〖s: 0.03, 95% CI(0.00, 0.06), P=0.04; s: 0.06, 95% CI(-0.02, 0.15), P=0.14\〗. In eyes treated with FLACS-MFIOL, SE showed no difference compared to CP-MFIOL \〖s: 0.06, 95% CI(-0.02, 0.15), P=0.14\〗, however, better than CP-MFIOL in distance and near pseudophakic accommodation \〖s: 0.57, 95% CI(0.42, 0.72), P<0.001; s: 1.32, 95% CI(0.99, 1.64), P<0.001\〗. Smaller CDE \〖s: -1.94, 95% CI(-2.59, -1.30), P<0.01; s: -3.81, 95% CI(-5.66, -1.96), P<0.01\〗 of Ⅱ and Ⅲ nucleus patients and increased ECD \〖s: 111.75, 95% CI(86.27, 137.23), P<0.01\〗 in FLACS-MFIOL group were analyzed. The sensitivity analysis indicated that the results were robust and no obvious reporting bias.

CONCLUSION: Compared to CP-MFIOL, FLACS-MFIOL makes a better visual quality and pseudophakic accommodation, as well as reducing endothelial cell loss and phacoemulsification energy.