ReZOOM与ReSTOR多焦点人工晶状体应用效果的Meta分析

Meta-analysis of clinical randomized controlled trials comparing ReZOOM with ReSTOR multifocal intraocular lenses in cataract surgery

目的:系统评价ReZOOM与ReSTOR两种多焦点人工晶状体(multifocal intraocular lens,MIOL)的临床应用效果。方法:计算机检索CENTRAL、MEDLINE、EMbase、万方医学网数据库、维普中文生物医学期刊全文数据库、中国生物医学文献数据库、中国期刊全文数据库,手工检索相关会议文献,纳入所有ReZOOM与ReSTOR对照的超声乳化白内障吸出联合IOL植入的随机对照试验。采用Cochrane系统评价方法,由两名评价员分别提取资料,评价方法学质量后,应用RevMan 5.2软件进行Meta分析。结果:共纳入7个随机对照试验(846眼)。结果显示:裸眼远视力:ReZOOM组与ReSTOR组间差异无统计学意义[WMD=-0.03,95%CI为(-0.06,0.01),P=0.15]。裸眼中距视力:ReZOOM组与ReSTOR组间差异无统计学意义[WMD=-0.04,95%CI为(-0.09,0.01),P=0.10]。裸眼近视力:ReZOOM组与ReSTOR组间差异有统计学意义[WMD=0.09,95%CI为(0.05,0.14),P<0.00001]。最佳矫正远视力:ReZOOM组与ReSTOR组间差异无统计学意义[WMD=-0.01,95%CI为(-0.04,0.02),P=0.55]。最佳矫正远视下的中距视力:ReZOOM组与ReSTOR组间差异有统计学意义[WMD=-0.11,95%CI为(-0.16,-0.06),P<0.0001]。最佳矫正远视下的近视力:ReZOOM组与ReSTOR组间差异无统计学意义[WMD=0.06,95%CI为(-0.06,0.17),P=0.32]。脱镜率:ReZOOM组与ReSTOR组间差异有统计学意义[WMD=2.62,95%CI为(1.76,3.91),P<0.00001]。光晕发生率:ReZOOM组与ReSTOR组间差异有统计学意义[WMD=1.35,95%CI为(1.15,1.60),P=0.0004]。眩光发生率:ReZOOM组与ReSTOR组间差异有统计学意义[WMD=1.29,95%CI为(1.09,1.53),P=0.003]。结论:本研究表明,两种MIOL相比较,ReSTOR表现出更好的裸眼近视力,出现光晕、眩光等视觉不良反应的可能性更小,裸眼远视力及中距视力表现相同;在戴镜矫正状况下,ReZOOM的中距视力表现更佳,两种MIOL的远、近视力无差别。

AIM： To systematic review the effectiveness of refractive multifocal intraocular lens（MIOL）ReZOOM vs diffractive MIOL ReSTOR in the treatment of cataract.METHODS： Randomized controlled trials comparing refractive MIOL ReZOOM with diffractive MIOL ReSTOR were identified by searching CENTRAL, MEDLINE, EMbase, WANFANG MED ONLINE, CMJD, SinoMed, and CNKI. Related journals also were hand-searched. Methodological quality of randomized controlled trials（RCTs）was evaluated by simple evaluate method that recommended by the Cochrane Collaboration. Data extracted by two reviewers with designed extraction form. RevMan software（release 5.2）was used for data management and analysis.RESULTS：A total of 7 trials（846 eyes）were included for systematic review. Subgroup analyses were used according to different model comparison of ReSTOR MIOL. The results showed a significant difference in the mean of the best distance corrected intermediate visual acuity（BDCIVA）in the ReZOOM MIOL group with WMD= -0.11, 95% CI（-0.16, -0.06）（P〈0.0001）. It showed a significantly difference in the mean of the uncorrected near visual acuity（UCNVA）, complete spectacle independent rate, halo rate and glare rate in the ReSTOR MIOL group with WMD= 0.09, 95% CI（0.05, 0.14）（P〈0.00001）, WMD= 2.62, 95%CI（1.76, 3.91）（P〈0.00001）, WMD=1.35, 95% CI（1.15, 1.60）（P=0.0004）and WMD= 1.29, 95% CI（1.09, 1.53）（P=0.003）. There was no significant difference between the two groups in the mean of the uncorrected distance visual acuity（UCDVA）, the uncorrected intermediate visual acuity（UCIVA）, the best corrected distance visual acuity（BCDVA）and the best distance corrected near visual acuity（BDCNVA）with WMD -0.03, 95% CI（-0.06, 0.01）（P=0.15）, WMD= -0.04, 95% CI（-0.09, 0.01）（P=0.10）, WMD= -0.01, 95%CI（-0.04, 0.02）（P=0.55）and WMD= 0.06, 95% CI（-0.06, 0.17）（P=0.32）. CONCLUSION： Patients implanted with ReZOOM MIOL can provide better BDCIVA; patients implanted with ReSTOR MIOL show better UCNVA, are less likely to appear light halo, glare and other visual adverse reactions; correction in spectacles cases, patients implanted with ReZOOM or ReSTOR MIOL have considerable performances in the far and near visual acuity.