Xu Zequan, Cao Danmin, Chen Xu, Wu Song, Wang Xin, Wu Qiang
Department of Ophthalmology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, No. 600, Xuhui District, Shanghai, PR China.
Aier School of Ophthalmology, Central South University, Tianxin District, Changsha, Hunan Province, PR China.
PLoS One. 2017 Oct 26;12(10):e0186522. doi: 10.1371/journal.pone.0186522. eCollection 2017.
To compare the clinical performance between trifocal and bifocal intraocular lenses in bilateral cataract and/or refractive lens exchange (RLE) surgery.
A comprehensive literature search of PubMed, EMBASE, Cochrane Controlled Trials Register and Web of Science was performed through October 2016 to identify randomized, controlled trials (RCTs) and comparative cohort studies. The primary outcomes were uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), defocus curve, spectacle independence, patient satisfaction and contrast sensitivity. The secondary outcomes were residual sphere, spherical equivalent (SE), cylinder and complications.
Six RCTs and 2 cohort studies including 568 eyes (278 in the trifocal group and 290 in the bifocal group) were identified. There was a statically significant difference between the two groups in UDVA (WMD: -0.03, 95% CI: -0.05 to -0.01, P = 0.005), but the difference (0.03 log MAR) is not clinically significant. Intermediate visual acuity was better in the trifocal IOL group judging from UIVA and defocus curves. There was a statically significant difference between the two groups in residual cylinder (WMD: 0.11, 95% CI: 0.02 to 0.20, P = 0.02), and subgroup AT Lisa tri 839MP trifocal also showed significant better UNVA than bifocal IOLs (WMD: -0.13, 95% CI: -0.17 to -0.08, P<0.00001). However, no significant differences were observed in UNVA (WMD: -0.04, 95% CI: -0.11 to 0.02, P = 0.19), spectacle independence (WMD: 1.27, 95% CI: 0.89 to 18.15, P = 0.07), patient satisfaction (WMD: 4.01, 95% CI: 0.07 to 22.72, P = 0.87), residual sphere (WMD: -0.03, 95% CI: -0.18 to 0.13, P = 0.74), SE (WMD: 0.04, 95% CI: -0.09 to 0.16, P = 0.55) or complications (WMD: 2.08, 95% CI: 0.35 to 12.43, P = 0.42).
Trifocal IOL technology (especially AT Lisa trifocal 839M trifocal) had a clear advantage over bifocal IOLs in intermediate visual acuity, while both trifocal IOLs and bifocal IOLs showed excellent performance in distance visual acuity. AT Lisa trifocal 839M trifocal could provide better uncorrected near visual acuity than bifocal IOLs. However, more evidence is needed to compare their spectacle independence, higher satisfaction rate, and photic phenomena.
比较三焦点人工晶状体与双焦点人工晶状体在双侧白内障和/或屈光性晶状体置换(RLE)手术中的临床表现。
通过检索截至2016年10月的PubMed、EMBASE、Cochrane对照试验注册库和科学网,以识别随机对照试验(RCT)和比较队列研究。主要结局指标为未矫正远视力(UDVA)、未矫正中视力(UIVA)、未矫正近视力(UNVA)、散焦曲线、脱镜率、患者满意度和对比敏感度。次要结局指标为残余球镜度、等效球镜度(SE)、柱镜度和并发症。
共纳入6项RCT和2项队列研究,涉及568只眼(三焦点组278只眼,双焦点组290只眼)。两组间UDVA存在统计学显著差异(加权均数差:-0.03,95%置信区间:-0.05至-0.01,P = 0.005),但差异(0.03 log MAR)无临床意义。从UIVA和散焦曲线判断,三焦点人工晶状体组的中视力更好。两组间残余柱镜度存在统计学显著差异(加权均数差:0.11,95%置信区间:0.02至0.20,P = 0.02),亚组AT Lisa tri 839MP三焦点人工晶状体的UNVA也显著优于双焦点人工晶状体(加权均数差:-0.13,95%置信区间:-0.17至-0.08,P<0.00001)。然而,在UNVA(加权均数差:-0.04,95%置信区间:-0.11至0.02,P = 0.19)、脱镜率(加权均数差:1.27,95%置信区间:0.89至18.15,P = 0.07)、患者满意度(加权均数差:4.01,95%置信区间:0.07至22.72,P = 0.87)、残余球镜度(加权均数差:-0.03,95%置信区间:-0.18至0.13,P = 0.74)、SE(加权均数差:0.04,95%置信区间:-0.09至0.16,P = 0.55)或并发症(加权均数差:2.08,95%置信区间:0.35至12.43,P = 0.42)方面未观察到显著差异。
三焦点人工晶状体技术(尤其是AT Lisa三焦点839M)在中视力方面比双焦点人工晶状体具有明显优势,而三焦点人工晶状体和双焦点人工晶状体在远视力方面均表现出色。AT Lisa三焦点839M能提供比双焦点人工晶状体更好的未矫正近视力。然而,需要更多证据来比较它们的脱镜率、更高的满意度和光学现象。