PDF(Pubmed)
Abstract：
BACKGROUND: Cataract, defined as an opacity of the lens in one or both eyes, is the leading cause of blindness worldwide. Cataract may initially be treated with new spectacles, but often surgery is required, which involves removing the cataract and placing a new artificial lens, usually made from hydrophobic acrylic. Recent advancements in intraocular lens (IOL) technology have led to the emergence of a diverse array of implantable lenses that aim to minimise spectacle dependence at all distances (near, intermediate, and distance). To assess the relative merits of these lenses, measurements of visual acuity are needed. Visual acuity is a measurement of the sharpness of vision at a distance of 6 metres (or 20 feet). Normal vision is 6/6 (or 20/20). The Jaegar eye card is used to measure near visual acuity. J1 is the smallest text and J2 is considered equivalent to 6/6 (or 20/20) for near vision.
OBJECTIVE: To compare visual outcomes after implantation of trifocal intraocular lenses (IOLs) to those of extended depth of focus (EDOF) IOLs. To produce a brief economic commentary summarising recent economic evaluations that compare trifocal IOLs with EDOF IOLs.
METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase, and three trial registries on 15 June 2022. For our economic evaluation, we also searched MEDLINE and Embase using economic search filters to 15 June 2022, and the NHS Economic Evaluation Database (EED) from 1968 up to and including 31 December 2014. We did not use any date or language restrictions in the electronic searches.
METHODS: We included studies comparing trifocal and EDOF IOLs in adults undergoing cataract surgery. We did not include studies involving people receiving IOLs for correction of refractive error alone (or refractive lens exchange in the absence of cataract).
METHODS: We used standard Cochrane methods. Two review authors working independently selected studies for inclusion and extracted data from the reports. We assessed the risk of bias in the studies, and we assessed the certainty of the evidence using the GRADE approach.
RESULTS: We included five studies that compared trifocal and EDOF lenses in people undergoing cataract surgery. Three trifocal lenses (AcrySof IQ PanOptix, ATLISA Tri 839MP, FineVision Micro F) and one EDOF lens (TECNIS Symfony ZXR00) were evaluated. The studies took place in Europe and North America. Follow-up ranged from three to six months. Of the 239 enroled participants, 233 (466 eyes) completed follow-up and were included in the analyses. The mean age of participants was 68.2 years, and 64% of participants were female. In general, the risk of bias in the studies was unclear as methods for random sequence generation and allocation concealment were poorly reported, and we judged one study to be at high risk of performance and detection bias. We assessed the certainty of the evidence for all outcomes as low, downgrading for the risk of bias and for imprecision. In two studies involving a total of 254 people, there was little or no difference between trifocal and EDOF lenses for uncorrected and corrected distance visual acuity worse than 6/6. Sixty per cent of participants in both groups had uncorrected distance visual acuity worse than 6/6 (risk ratio (RR) 1.06, 95% confidence intervals (CI) 0.88 to 1.27). Thirty-one per cent of the trifocal group and 38% of the EDOF group had corrected distance visual acuity worse than 6/6 (RR 1.04, 95% CI 0.78 to 1.39). In one study of 60 people, there were fewer cases of uncorrected near visual acuity worse than J2 in the trifocal group (3%) compared with the EDOF group (30%) (RR 0.08, 95% CI 0.01 to 0.65). In two studies, participants were asked about spectacle independence using subjective questionnaires. There was no evidence of either lens type being superior. One further study of 60 participants reported, \"overall, 90% of patients achieved spectacle independence\", but did not categorise this by lens type. All studies included postoperative patient-reported visual function, which was measured using different questionnaires. Irrespective of the questionnaire used, both types of lenses scored well, and there was little evidence of any important differences between them. Two studies included patient-reported ocular aberrations (glare and halos). The outcomes were reported in different ways and could not be pooled; individually, these studies were too small to detect meaningful differences in glare and halos between groups. One study reported no surgical complications. Three studies did not mention surgical complications. One study reported YAG capsulotomy for posterior capsular opacification (PCO) in one participant (one eye) in each group. One study reported no PCO. Two studies did not report PCO. One study reported that three participants (one trifocal and two EDOF) underwent laser-assisted subepithelial keratectomy (LASEK) to correct residual myopic refractive error or astigmatism. One study reported a subset of participants who were considering laser enhancement at the end of the study period (nine trifocal and two EDOF). Two studies did not report laser enhancement rates. No economic evaluation studies were identified for inclusion in this review.
CONCLUSIONS: Distance visual acuity after cataract surgery may be similar whether the lenses implanted are trifocal IOLs or EDOF (TECNIS Symfony) IOLs. People receiving trifocal IOLs may achieve better near vision and may be less dependent on spectacles for near vision. Both lenses were reported to have adverse subjective visual phenomena, such as glare and halos, with no meaningful difference detected between lenses.
OBJECTIVE: To compare visual outcomes after implantation of trifocal intraocular lenses (IOLs) to those of extended depth of focus (EDOF) IOLs. To produce a brief economic commentary summarising recent economic evaluations that compare trifocal IOLs with EDOF IOLs.
METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase, and three trial registries on 15 June 2022. For our economic evaluation, we also searched MEDLINE and Embase using economic search filters to 15 June 2022, and the NHS Economic Evaluation Database (EED) from 1968 up to and including 31 December 2014. We did not use any date or language restrictions in the electronic searches.
METHODS: We included studies comparing trifocal and EDOF IOLs in adults undergoing cataract surgery. We did not include studies involving people receiving IOLs for correction of refractive error alone (or refractive lens exchange in the absence of cataract).
METHODS: We used standard Cochrane methods. Two review authors working independently selected studies for inclusion and extracted data from the reports. We assessed the risk of bias in the studies, and we assessed the certainty of the evidence using the GRADE approach.
RESULTS: We included five studies that compared trifocal and EDOF lenses in people undergoing cataract surgery. Three trifocal lenses (AcrySof IQ PanOptix, ATLISA Tri 839MP, FineVision Micro F) and one EDOF lens (TECNIS Symfony ZXR00) were evaluated. The studies took place in Europe and North America. Follow-up ranged from three to six months. Of the 239 enroled participants, 233 (466 eyes) completed follow-up and were included in the analyses. The mean age of participants was 68.2 years, and 64% of participants were female. In general, the risk of bias in the studies was unclear as methods for random sequence generation and allocation concealment were poorly reported, and we judged one study to be at high risk of performance and detection bias. We assessed the certainty of the evidence for all outcomes as low, downgrading for the risk of bias and for imprecision. In two studies involving a total of 254 people, there was little or no difference between trifocal and EDOF lenses for uncorrected and corrected distance visual acuity worse than 6/6. Sixty per cent of participants in both groups had uncorrected distance visual acuity worse than 6/6 (risk ratio (RR) 1.06, 95% confidence intervals (CI) 0.88 to 1.27). Thirty-one per cent of the trifocal group and 38% of the EDOF group had corrected distance visual acuity worse than 6/6 (RR 1.04, 95% CI 0.78 to 1.39). In one study of 60 people, there were fewer cases of uncorrected near visual acuity worse than J2 in the trifocal group (3%) compared with the EDOF group (30%) (RR 0.08, 95% CI 0.01 to 0.65). In two studies, participants were asked about spectacle independence using subjective questionnaires. There was no evidence of either lens type being superior. One further study of 60 participants reported, \"overall, 90% of patients achieved spectacle independence\", but did not categorise this by lens type. All studies included postoperative patient-reported visual function, which was measured using different questionnaires. Irrespective of the questionnaire used, both types of lenses scored well, and there was little evidence of any important differences between them. Two studies included patient-reported ocular aberrations (glare and halos). The outcomes were reported in different ways and could not be pooled; individually, these studies were too small to detect meaningful differences in glare and halos between groups. One study reported no surgical complications. Three studies did not mention surgical complications. One study reported YAG capsulotomy for posterior capsular opacification (PCO) in one participant (one eye) in each group. One study reported no PCO. Two studies did not report PCO. One study reported that three participants (one trifocal and two EDOF) underwent laser-assisted subepithelial keratectomy (LASEK) to correct residual myopic refractive error or astigmatism. One study reported a subset of participants who were considering laser enhancement at the end of the study period (nine trifocal and two EDOF). Two studies did not report laser enhancement rates. No economic evaluation studies were identified for inclusion in this review.
CONCLUSIONS: Distance visual acuity after cataract surgery may be similar whether the lenses implanted are trifocal IOLs or EDOF (TECNIS Symfony) IOLs. People receiving trifocal IOLs may achieve better near vision and may be less dependent on spectacles for near vision. Both lenses were reported to have adverse subjective visual phenomena, such as glare and halos, with no meaningful difference detected between lenses.
摘要：
背景：白内障，定义为一只或两只眼睛的晶状体不透明度，是全球失明的主要原因。白内障最初可以用新眼镜治疗，但通常需要手术，其中包括摘除白内障和放置新的人工晶状体，通常由疏水丙烯酸制成。人工晶状体（IOL）技术的最新进展导致出现了各种各样的可植入晶状体，旨在最大程度地减少所有距离的眼镜依赖性（近，中间,和距离）。为了评估这些镜片的相对优点，需要测量视力。视敏度是在6米（或20英尺）的距离处对视觉清晰度的测量。正常视力为6/6（或20/20）。Jaegar眼卡用于测量近视敏度。J1是最小的文本，J2被认为相当于近视力的6/6（或20/20）。
目的：比较三焦点人工晶状体（IOL）和扩展焦深（EDOF）人工晶状体植入后的视觉结果。撰写简短的经济评论，总结最近的经济评估，将三焦点IOL与EDOFIOL进行比较。
方法：我们搜索了CENTRAL（包含Cochrane眼睛和视力试验注册），MEDLINE,Embase,和2022年6月15日的三个审判登记处。对于我们的经济评估，我们还使用经济搜索过滤器搜索了截至2022年6月15日的MEDLINE和Embase,以及1968年至2014年12月31日的NHS经济评估数据库(EED).我们在电子搜索中没有使用任何日期或语言限制。
方法：我们纳入了比较接受白内障手术的成人三焦IOL和EDOFIOL的研究。我们没有纳入涉及接受IOL的人单独矫正屈光不正（或在没有白内障的情况下更换屈光晶状体）的研究。
方法：我们使用标准Cochrane方法。两名综述作者独立选择纳入研究，并从报告中提取数据。我们在研究中评估了偏倚的风险，我们使用等级方法评估了证据的确定性。
结果：我们纳入了五项研究，比较了接受白内障手术的患者的三焦点和EDOF晶状体。三个三焦点镜头(AcrySofIQPanOptix,ATLISATri839MP,评估FineVisionMicroF）和一个EDOF镜头（TECNISSymfonyZXR00）。这些研究在欧洲和北美进行。随访3至6个月。在239名参与者中，233(466只眼)完成随访，并纳入分析。参与者的平均年龄为68.2岁，64%的参与者是女性。总的来说,研究中的偏倚风险尚不清楚，因为随机序列生成和分配隐藏的方法报道很少，我们判断一项研究的性能和检测偏差的风险很高。我们评估所有结果的证据的确定性都很低，降低偏见风险和不精确风险。在两项涉及254人的研究中，对于未矫正和矫正的远距视力低于6/6，三焦点和EDOF镜片之间几乎没有差异。两组中有60％的参与者的未矫正远距视力均低于6/6（风险比（RR）1.06，95％置信区间（CI）0.88至1.27）。三灶组的31％和EDOF组的38％的矫正视力差于6/6（RR1.04，95％CI0.78至1.39）。在一项针对60人的研究中，与EDOF组(30%)相比,三焦组(3%)的未矫正近视力低于J2的病例较少(RR0.08,95%CI0.01~0.65).在两项研究中，使用主观问卷对参与者的眼镜独立性进行了询问.没有证据表明任何一种镜片类型都是优越的。一项对60名参与者的进一步研究报告说，“总的来说，90%的患者实现了眼镜独立性，“，但没有按镜头类型分类。所有研究包括术后患者报告的视觉功能，这是使用不同的问卷测量的。不考虑使用的问卷，两种类型的镜片得分都很好，几乎没有证据表明它们之间有任何重要的区别。两项研究包括患者报告的眼像差（眩光和光晕）。结果以不同的方式报告，无法汇总；个别地，这些研究规模太小，无法检测到两组之间眩光和光晕的有意义差异。一项研究报告没有手术并发症。三项研究没有提到手术并发症。一项研究报道了每组一名参与者（一只眼睛）的YAG囊切开术用于后囊混浊（PCO）。一项研究报告没有PCO。两项研究未报告PCO。一项研究报告说，三名参与者（一个三焦和两个EDOF）接受了激光辅助上皮下角膜切除术（LASEK），以纠正残留的近视屈光不正或散光。一项研究报告了在研究结束时考虑激光增强的一部分参与者（9个三焦点和2个EDOF）。两项研究未报告激光增强率。没有确定纳入本审查的经济评估研究。
结论：白内障手术后的远距视力可能相似，无论植入的晶状体是三焦点IOL还是EDOF（TECNISSymfony）IOL。接受三焦点IOL的人可以获得更好的近视力，并且可以更少地依赖眼镜进行近视力。据报道，两种镜片都有不利的主观视觉现象，如眩光和光晕，在镜片之间没有检测到有意义的差异。
目的：比较三焦点人工晶状体（IOL）和扩展焦深（EDOF）人工晶状体植入后的视觉结果。撰写简短的经济评论，总结最近的经济评估，将三焦点IOL与EDOFIOL进行比较。
方法：我们搜索了CENTRAL（包含Cochrane眼睛和视力试验注册），MEDLINE,Embase,和2022年6月15日的三个审判登记处。对于我们的经济评估，我们还使用经济搜索过滤器搜索了截至2022年6月15日的MEDLINE和Embase,以及1968年至2014年12月31日的NHS经济评估数据库(EED).我们在电子搜索中没有使用任何日期或语言限制。
方法：我们纳入了比较接受白内障手术的成人三焦IOL和EDOFIOL的研究。我们没有纳入涉及接受IOL的人单独矫正屈光不正（或在没有白内障的情况下更换屈光晶状体）的研究。
方法：我们使用标准Cochrane方法。两名综述作者独立选择纳入研究，并从报告中提取数据。我们在研究中评估了偏倚的风险，我们使用等级方法评估了证据的确定性。
结果：我们纳入了五项研究，比较了接受白内障手术的患者的三焦点和EDOF晶状体。三个三焦点镜头(AcrySofIQPanOptix,ATLISATri839MP,评估FineVisionMicroF）和一个EDOF镜头（TECNISSymfonyZXR00）。这些研究在欧洲和北美进行。随访3至6个月。在239名参与者中，233(466只眼)完成随访，并纳入分析。参与者的平均年龄为68.2岁，64%的参与者是女性。总的来说,研究中的偏倚风险尚不清楚，因为随机序列生成和分配隐藏的方法报道很少，我们判断一项研究的性能和检测偏差的风险很高。我们评估所有结果的证据的确定性都很低，降低偏见风险和不精确风险。在两项涉及254人的研究中，对于未矫正和矫正的远距视力低于6/6，三焦点和EDOF镜片之间几乎没有差异。两组中有60％的参与者的未矫正远距视力均低于6/6（风险比（RR）1.06，95％置信区间（CI）0.88至1.27）。三灶组的31％和EDOF组的38％的矫正视力差于6/6（RR1.04，95％CI0.78至1.39）。在一项针对60人的研究中，与EDOF组(30%)相比,三焦组(3%)的未矫正近视力低于J2的病例较少(RR0.08,95%CI0.01~0.65).在两项研究中，使用主观问卷对参与者的眼镜独立性进行了询问.没有证据表明任何一种镜片类型都是优越的。一项对60名参与者的进一步研究报告说，“总的来说，90%的患者实现了眼镜独立性，“，但没有按镜头类型分类。所有研究包括术后患者报告的视觉功能，这是使用不同的问卷测量的。不考虑使用的问卷，两种类型的镜片得分都很好，几乎没有证据表明它们之间有任何重要的区别。两项研究包括患者报告的眼像差（眩光和光晕）。结果以不同的方式报告，无法汇总；个别地，这些研究规模太小，无法检测到两组之间眩光和光晕的有意义差异。一项研究报告没有手术并发症。三项研究没有提到手术并发症。一项研究报道了每组一名参与者（一只眼睛）的YAG囊切开术用于后囊混浊（PCO）。一项研究报告没有PCO。两项研究未报告PCO。一项研究报告说，三名参与者（一个三焦和两个EDOF）接受了激光辅助上皮下角膜切除术（LASEK），以纠正残留的近视屈光不正或散光。一项研究报告了在研究结束时考虑激光增强的一部分参与者（9个三焦点和2个EDOF）。两项研究未报告激光增强率。没有确定纳入本审查的经济评估研究。
结论：白内障手术后的远距视力可能相似，无论植入的晶状体是三焦点IOL还是EDOF（TECNISSymfony）IOL。接受三焦点IOL的人可以获得更好的近视力，并且可以更少地依赖眼镜进行近视力。据报道，两种镜片都有不利的主观视觉现象，如眩光和光晕，在镜片之间没有检测到有意义的差异。
