Comparison of the Clinical Performance of Refractive Rotationally Asymmetric Multifocal IOLs with Other Types of IOLs: A Meta-Analysis.
1. IntroductionDue to the popularity and availability of premium intraocular lens (IOLs), the main goal of cataract surgery has shifted from sight rehabilitation to restoring vision at as many distances as possible, including distance, intermediate, and near vision. Many types of premium IOL are now available, including accommodating IOL and multifocal IOLs. Multifocal IOLs can be categorized according to their design as diffractive lenses, refractive lenses, and lenses involving both diffractive and refractive designs [1, 2].
As a new multifocal IOL concept, refractive rotational asymmetry has been introduced into clinical practice for about a half decade, the main part of the lens behaves as a standard monofocal IOL, but in a specific sector of the lens, light is split into numerous foci. The Lentis Mplus LS-312 MF is the first commercially available refractive rotational asymmetry IOL and is a biconvex acrylic single-piece IOL containing a sector-shaped near-vision area with a +3.00 D addition (add) (+3 D for LS-312 MF 30; +1.5 D for LS-312 MF 15) [3] and an aspheric distance-vision zone. Since there is a smooth transition between the two zones, intermediate visual acuity might be improved to some extent [4, 5].
Several studies have compared the Lentis Mplus LS-312 MF30, LS-312 MF15, or LS-313 MF30 with other types of IOL [6-14]; however, the results have not always been consistent. To the best of our knowledge, this report represents the first meta-analysis of the clinical performance of refractive rotational asymmetry lenses.
2. Material and Methods
This study was registered at International Prospective Register of Systematic Reviews and was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA).
2.1. Search Strategy and Screening Process. Two reviewers (Z. X. and W. L.) independently searched PubMed, EMBASE, the Cochrane Controlled Trials Register and Web of Science using the following search terms as keywords: segmental refractive multifocal intraocular lens, rotationally asymmetric multifocal intraocular lens, LENTIS Mplus, and SBL 3. No limits were put on the language of the publication. The full articles were carefully analysed after a preliminary review of the titles and abstracts. A third reviewer (Xu Chen) was asked to adjudicate when disagreement existed between Z. X. and W. L.
2.2. Eligibility. We included all studies comparing rotationally asymmetric multifocal IOLs and other IOLs used in patients undergoing cataract surgery and/or refractive lens exchange surgery. However, studies involving patients with coexisting pathology and previous IOL implantation were excluded.
2.3. Data Collection. Using a standardized data-collection form, two reviewers (X. X. and W. L.) independently extracted the data characteristics of the included studies; we attempted to obtain missing data by emailing the authors directly.
2.4. Quality Assessment. For all included cohort studies, the Newcastle-Ottawa Scale (NOS) [15] was used for quality assessment. The maximum NOS score is nine points, and a score of seven points indicates good quality. This scale includes three areas: patient selection (four points maximum), outcome assessment (two points maximum), and comparability (two points maximum).
2.5. Outcome Measures. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), distance-corrected near visual acuity (DCNVA), and corrected near visual acuity (CNVA) were recorded at logMAR; distance visual acuity was recorded at 4 or 6 m, intermediate visual acuity was recorded at 70, 63, or 66 cm, and near visual acuity was recorded at 40 or 33 cm. Distance, intermediate, and near visual acuity could also be determined based on defocus curves. Contrast sensitivity testing was performed under photopic conditions (85 cd/[m.sup.2]) and mesopic conditions (3 cd/[m.sup.2]). Data regarding MTF, Strehl ratio, higher-order aberrations (HOAs), and residual sphere and cylinder were also collected if provided. The MTF cut-off point represented the point where the spatial frequency was maximal and the Strehl ratio is the ratio of peak focal intensities in the aberrated and ideal ocular point spread function (PSF), both of which had a theoretic relationship with the visual quality [7].
2.6. Statistical Analysis. The data were analysed using Rev Manager Software (version 5.3; Cochrane Collaboration, Oxford, United Kingdom). Forest plots were used to present the results, and chi-square and [I.sup.2] tests were used to test for statistical heterogeneity; a random-effects meta-analysis was used when [I.sup.2] > 50%, and a fixed-effects models was used otherwise [16]. The weighted mean difference (WMD) with 95% (confidence intervals) CIs was calculated. Statistical significance was defined as a P-value of less than 0.05. And for visual acuity, 0.1 logMAR was to be assumed clinically significant [17].
3. Results
Figure 1 shows a flow diagram of the included and excluded studies. The search strategy generated 169 potentially relevant studies, of which nine [6-14] were included in our quantitative synthesis; all nine studies were nonrandomized cohort studies.
3.1. Characteristics of the Included Studies. Table 1 shows the characteristics of the nine studies that met all inclusion criteria. All studies were comparative cohort trials and were performed in Europe, and all patients underwent cataract surgery except that in one study [14], some patients underwent refractive lens exchange surgery. Mplus IOLs (312 MF30, 313 MF30, and 312 MF30) were used in the refractive rotationally asymmetric multifocal IOL group, and spherical monofocal (Acri.Smart 48S) IOLs, accommodating IOLs (Crystalens HD), and refractive-diffractive bifocal IOLs (Acri.Lisa 366 and ReSTOR SN6AD 1/3) were used in comparison groups.
All but one of the nine studies had no missing cases [8], and all reported all of their main results; thus, eight studies [6, 7, 9-14] had three points for outcome assessment (three points maximum), and one study had two points [8]. All of the studies scored two points for comparability (two points maximum). One study had flaws in patient selection (four points maximum) [7] and did not match preoperative distance visual acuity and higher-order aberrations; thus, the study was scored as two points for patient selection. All other studies were scored as four points.
3.2. Quality of the Methodology Used. Table 2 shows the summary of outcomes (including the overall quality of evidence as assessed from GRADE/GDT).
3.3. Primary Outcome. The primary outcomes were distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), distance-corrected near visual acuity (DCNVA) and corrected near visual acuity (CNVA), higher-order aberrations (HOAs), MTF cut-off, and Strehl ratio.
3.3.1. Uncorrected Distance Visual Acuity (UDVA). Nine studies [6-14] reported UDVA. The mean UDVA in the Mplus group was 0.120 [+ or -] 0.269, which was not significantly different from that in the control group (WMD: 0.02, 95% CI: -0.01 to 0.04, P = 0.25) (Figure 2). The quality of the evidence was high (Figure S1). Subgroup analysis according to the type of IOL employed in the control group was conducted. Mplus provided significantly worse UDVA than spherical monofocal IOLs (WMD: 0.13, 95% CI: 0.03 to 0.22, P = 0.008). The quality of the evidence is shown in Figure S1.
3.3.2. Corrected Distance Visual Acuity (CDVA). Eight studies [6-13] reported CDVA. The mean CDVA in the Mplus group was significantly worse than that in the control group (WMD: 0.03, 95% CI: 0.00 to 0.07, P = 0.03) (Figure 2); however, the difference was not clinically significant. Subgroup analysis according to the type of IOL employed in the control group was also conducted. Mplus resulted in significantly worse CDVA than low-add refractive-diffractive bifocal IOLs (WMD: 0.08, 95% CI: 0.06 to 0.10, P < 0.00001). The quality of the evidence is shown in Figure S2.
3.3.3. Uncorrected Intermediate Visual Acuity (UIVA). Eight studies [6-13] reported UIVA. The mean UIVA in the Mplus group was 0.160 [+ or -] 0.118, which was significantly better than that in the control group (WMD: -0.16, 95% CI: -0.26 to -0.05, P = 0.004) (Figure 3). Subgroup analysis according to the type of IOL employed in the control group was also conducted. Mplus resulted in significantly better UIVA than high-add refractive-diffractive bifocal IOLs (WMD: -0.19, 95% CI: -0.22 to -0.17, P < 0.00001), spherical monofocal IOLs (WMD: -0.12, 95% CI: -0.18 to -0.06, P < 0.0001), and accommodating IOLs (WMD: -0.21, 95% CI: -0.28 to -0.14, P < 0.00001). The quality of the evidence is shown in Figure S3.
3.3.4. Uncorrected near Visual Acuity (UNVA). Eight studies [6-13] reported UNVA. The mean UNVA in the Mplus group was 0.196 [+ or -] 0.158, almost the same as that in the control group (WMD: -0.00, 95% CI: -0.04 to 0.04, P = 1) (Figure 4). Subgroup analysis according to the type of IOL used in the control group was also conducted. Mplus provided significantly worse UNVA than high-add refractive-diffractive bifocal IOLs (WMD: 0.07, 95% CI: 0.04 to 0.09, P < 0.00001), although the difference was not very clinically significant. However, Mplus provided significantly better UNVA than spherical monofocal IOLs (WMD: -0.19, 95% CI: -0.28 to -0.11, P < 0.00001). The quality of the evidence is shown in Figure S4.
3.3.5. Distance-Corrected Near Visual Acuity (DCNVA). Eight studies [6-13] reported DCNVA. The mean DCNVA in the Mplus group was almost the same as that in the control group (WMD: -0.02, 95% CI: -0.08 to 0.05, P = 0.63) (Figure 4). Subgroup analysis according to the type of IOL used in the control group was also conducted. Mplus resulted in significantly worse DCNVA than high-add refractive-diffractive bifocal IOLs (WMD: 0.13, 95% CI: 0.10 to 0.16, P < 0.00001), and the difference was clinically significant. However, Mplus resulted in significantly better DCNVA than spherical monofocal IOLs (WMD: -0.32, 95% CI: -0.40 to -0.24, P < 0.00001). The quality of the evidence is shown in Figure S5.
3.3.6. Corrected Near Visual Acuity (CNVA). Four studies [7, 8,11,12] reported CNVA. The mean CNVA in the Mplus group was worse than that in the control group (WMD: 0.04, 95% CI: 0.01 to 0.07, P = 0.009) (Figure 4), although the difference was not clinically significant. Subgroup analysis according to the type of IOL used in the control group was also conducted. Mplus resulted in significantly worse CNVA than high-add refractive-diffractive bifocal IOLs (WMD: 0.03, 95% CI: -0.00 to 0.07, P = 0.05), although the difference was not clinically significant. The quality of the evidence is shown in Figure S6.
3.3.7. Higher-Order Aberrations (HOAs). Four studies [7, 8, 11, 12] reported residual higher-order aberrations (HOAs). The HOAs of the fours studies were recorded by the same ocular aberrometry (COAS; Wavefront Sciences Inc, Albuquerque, New Mexico). The mean number of HOAs in the Mplus group was significantly higher than that in the control group (WMD: 0.34,95% CI: 0.15 to 0.53, P = 0.0004) (Figure 5). Subgroup analysis according to the type of IOL used in the control group was also conducted. Mplus resulted in significantly higher HOAs than high-add refractive-diffractive bifocal IOLs (WMD: 0.38, 95% CI: 0.27 to 0.49, P < 0.00001) and spherical monofocal IOLs (WMD: 0.51, 95% CI: 0.33 to 0.69, P = 0.0004). The quality of the evidence is shown in Figure S7.
3.3.8. MTF Cut-Off. Higher values of MTF cut-off indicate better vision quality. Four studies [7, 8, 11, 12] reported residual MTF cut-off. The mean MTF cut-off in the Mplus group was significantly lower than that in the control group (WMD: -2.34, 95% CI: -3.98 to -0.69, P = 0.005) (Figure 5). Subgroup analysis according to the type of IOL used in the control group was also conducted. Mplus resulted in a significantly lower MTF cut-off than high-add refractive-diffractive bifocal IOLs (WMD: -4.56, 95% CI: -7.24 to -1.87, P = 0.0009). The quality of the evidence is shown in Figure S8.
3.3.9. Strehl Ratio. Higher values of the Strehl ratio indicate better vision quality. Four studies [7, 8, 11, 12] reported the residual Strehl ratio. The mean Strehl ratio in the Mplus group was significantly lower than that in the control group (WMD: -0.02, 95% CI: -0.03 to -0.01, P = 0.0009) (Figure 5). Subgroup analysis according to the type of IOL used in the control group was also conducted. Mplus resulted in significantly lower Strehl ratios than high-add refractive-diffractive bifocal IOLs (WMD: -0.02, 95% CI: -0.04 to -0.01, P = 0.004) and accommodating IOLs (WMD: -0.02, 95% CI: -0.04 to -0.00, P = 0.02). The quality of the evidence is shown in Figure S9.
3.3.10. Defocus Curve. Seven studies [6-8, 11-14] reported defocus curves, and a summary of the results is shown in Table 3. The results of defocus curve were consistent with the visual acuity results.
3.3.11. Contrast Sensitivity. Six studies [7-9, 11-13] reported contrast sensitivity, and a summary of the results is shown in Table 4. Under the photopic condition, high-add Mplus IOLs yielded significantly better performance at 12 and 18 c/d than high-add bifocal IOLs but significantly worse performance at 12 and 18c/d than low-add bifocal IOLs. Low-add Mplus IOLs resulted in significantly worse performance at 3, 6, 12, and 18c/d than accommodating IOLs. Under the low conditions, Mplus IOLs had a tendency to provide worse results than spherical monofocal IOLs and accommodating IOLs.
3.4. Secondary Outcomes. The secondary outcomes were residual sphere and cylinder.
3.4.1. Residual Sphere. Eight studies [7-14] reported residual sphere. The mean residual sphere in the Mplus group was significantly lower than that in the control group (WMD: -0.12, 95% CI: -0.23 to -0.02, P = 0.02). The difference, however, was not clinically significant.
3.4.2. Residual Cylinder. Eight studies [7-14] reported residual cylinder. The mean residual sphere in the Mplus group was not significantly different from that in the control group (WMD: 0.18, 95% CI: -0.22 to 0.57, P = 0.38).
4. Discussion
This is a meta-analysis which compares a refractive rotationally asymmetric multifocal intraocular lens (Mplus IOL) and an accommodative, a monofocal, or a bifocal IOL, respectively. Outcome parameters such as uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), etc., were determined. Our findings suggested that asymmetric multifocal IOLs provide good, but not perfect, results in terms of objective visual performance and vision quality.
Uncorrected distance visual acuity (UDVA) following implantation of Mplus IOLs was good and not significantly different from those following the implantation of accommodating IOLs and refractive-diffractive bifocal IOLs. In an extensive study including 9366 eyes by Venter et al. [18], the mean UDVA of Mplus IOLs was 0.054 [+ or -] 0.146 logMAR; the results were similar to those obtained in our study. However, the UDVA performance of Mplus IOLs was inferior to that of spherical monofocal IOLs in our study, and the difference between them was not only statistically (P = 0.008) but also clinically (0.13 logMAR) significant. Thus, Mplus IOLs still have room to improve in terms of distance visual acuity.
Mplus IOLs exhibited better uncorrected intermediate visual acuity (UIVA) than spherical monofocal IOLs, accommodating IOLs, and high-add refractive-diffractive bifocal IOLs (+4 D, +3.75 D). The difference between Mplus IOLs and other IOLs (spherical monofocal, accommodating, and high-add refractive-diffractive bifocal IOLs) was clinically significant (0.12 logMAR, 0.21 logMAR, and 0.19 logMAR, respectively). It is worth noting that the refractive rotationally asymmetric multifocal IOL that was compared with the accommodating IOLs was a low-add Mplus IOL (+1.5 D), which exhibited superior intermediate visual performance than high-add Mplus IOLs (+3.0 D) [3], and this may have partially contributed to the clear advantage over accommodating IOLs. Further analysis may be needed to compare high-add Mplus IOLs (+3.0 D) and accommodating IOLs. In a study by Munoz et al. the mean UIVA of Mplus IOLs was 0.13 [+ or -] 0.12 logMAR [19], and these results were similar to those obtained in our study. Thus, satisfying intermediate visual acuity was achieved using Mplus IOLs. Two reasons might explain the improvement of UIVA: 1, the transition zone between distance- and near-vision sectors was smooth and gradual; 2, the slight induction of HOAs (mainly coma and trefoil) may provide a certain depth of focus.
Mplus IOLs exhibited good uncorrected near visual acuity (UNVA). Unsurprisingly, Mplus IOLs performed better than spherical monofocal IOLs. Furthermore, Mplus IOLs also performed better than accommodating IOLs, but the difference was not as clinically significant (0.09 logMAR). This was an encouraging result since a previous meta-analysis had already shown that accommodating IOLs can restore satisfying near vision without compromising distance vision [20]. However, almost no difference was found between Mplus and low-add refractive-diffractive bifocal IOLs (+3 D). Finally, Mplus had a statistically (P < 0.00001) inferior performance to that of high-add refractive-diffractive bifocal IOLs (+4 D, +3.75 D), but this difference was not clinically significant (0.07 logMAR). In the extensive study by Venter et al. [18], the mean UNVA of Mplus IOLs was 0.213 [+ or -] 0.173 logMAR, and the results were similar in our study. Thus, both refractive-diffractive bifocal IOLs [2, 21, 22] and Mplus provide excellent near visual performance; in addition, accommodating IOLs also performed well, and all were significantly better than spherical monofocal IOLs.
Higher-order aberrations were significantly greater in eyes that were implanted with Mplus IOLs than in those implanted with refractive-diffractive bifocal IOLs and spherical monofocal IOLs, which exhibit strong spherical aberrations [23, 24]. Aberrations were tend to be significantly greater in eyes that had been implanted with Mplus IOLs than in those that had been implanted with accommodating IOLs. The presence of strong intraocular higher-order aberrations in Mplus IOLs is usually attributed to coma and trefoil [4, 25], which in turn are usually attributed to its design, which involves vertical asymmetric optical geometry [4, 26]. IOL tilt is caused by ineffectiveness in stabilizing the lens [12, 27] or by placing the near segment inferiorly with slight nasal deviation as recommended by manufacturers' guidelines [25, 28, 29].
IOLs with a rotationally asymmetrical design contributes significantly towards vision quality [30]; however, this lens type exhibited decreased vision quality compared with accommodating IOLs and refractive-diffractive bifocal IOLs. Moreover, no significant differences were found in MTF cut-off and Strehl ratio between Mplus and the spherical monofocal IOLs, whose vision quality was limited by residual spherical aberrations. The large amount of residual higher-order aberrations may be the main reason for the limited vision quality provided by Mplus IOLs, as mentioned above.
Contrast sensitivity is a well-recognized parameter that is used to assess the quality of vision of pseudophakic eyes and reflects the lowest contrast level that can be detected for a given size target [31]. Reduced contrast sensitivity is one of the main reasons for dissatisfaction in postoperative cataract patients [32]. Rotationally asymmetrical designs aim to increase contrast sensitivity and alleviate photopic phenomena [33], and this goal is achieved to some extent; however, lenses of this type still face decreased contrast sensitivity. The increased higher-order aberrations mentioned above may partially attribute to the decreased contrast sensitivity of Mplus IOLs.
This study has several limitations. First, further analysis is required regarding many other related types of IOLs, such as Mplus (+2 D or +1.5 D) and SBL-3 IOLs in the refractive rotationally asymmetric multifocal groups, trifocal IOLs and +2.5 D bifocal IOLs in the multifocal groups, and 1CU IOLs and wiol-cf IOLs in the accommodating IOLs group. Second, one study [14] received grants from Alcon Laboratories (Fort Worth, TX, USA). Third, publication bias may occur, but we failed to do funnel plots because the number of the studies included in each subgroup is limited. Fourth, four referred articles reporting higher-order aberrations, MTF cut-off, and Strehl ratio included in the present meta-analysis have been published by the same research group.
To conclude, the refractive rotationally asymmetric multifocal IOLs provided improved intermediate visual acuity and satisfying distance visual acuity, as well as acceptable near visual acuity, all of which led to less need for spectacles. High-add Mplus IOLs provided superior intermediate and near but inferior distance visual performance compared to spherical monofocal IOLs and provided superior intermediate but inferior near visual performance compared to high-add refractive-diffractive bifocal IOLs. Low-add Mplus IOLs provided superior intermediate and near visual performance compared to accommodating IOLs. However, Mplus IOLs resulted in some residual higher-order aberrations that might affect the corrected visual acuity and quality of vision. Thus, we recommend that asymmetric multifocal IOLs be considered an important member of the IOL family.
https://doi.org/10.1155/2018/4728258
Disclosure
The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Conflicts of Interest
All authors declare that they have no conflicts of interest.
Authors' Contributions
Qiang Wu and Xu Chen contributed equally to this article. Zequan Xu, Wenzhe Li, and Lianqun Wu contributed equally to this work and should be considered as equal first authors.
Acknowledgments
We thank Professor Alio and Professor Plaza for providing unpublished data (postoperation uncorrected intermediate visual acuity of patients). This study was supported by the Project of Shanghai Municipal Commission of Health and Family Planning (Project nos. 201440029 and 201640120) and by the National Natural Science Foundation of China (Grant no. 81600765).
Supplementary Materials
Figure S1: quality of evidence (UDVA). Figure S2: quality of evidence (CDVA). Figure S3: quality of evidence (UIVA). Figure S4: quality of evidence (UNVA). Figure S5: quality of evidence (DCNVA). Figure S6: quality of evidence (CNVA). Figure S7: quality of evidence, Higher-order aberrations (HOAs). Figure S8: quality of evidence (MTF cut-off). Figure S9: quality of evidence (Strehl ratio). (Supplementary Materials)
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Zequan Xu, (1) Wenzhe Li, (2) Lianqun Wu, (3) Shuang Xue, (4) Xu Chen [ID], (5) and Qiang Wu [ID] (1)
(1) Department of Ophthalmology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, No. 600, Yishan Road, Xuhui District, Shanghai 200233, China
(2) Clinical Medical College, Tianjin Medical University, No. 176, Xueyuan Road, Dagang District, Tianjin 100270, China
(3) Department of Ophthalmology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003 Shanghai, China
(4) Department of Ophthalmology, People's Hospital of Hegang, No. 1, Dianxin Road, Gongnong District, Hegang 154100, Heilongjiang, China
(5) Department of Cataract and Glaucoma, Shanghai Aier Eye Hospital, No. 1286, Hongqiao Road, Shanghai 200336, China
Correspondence should be addressed to Xu Chen; [email protected] and Qiang Wu; [email protected]
Received 6 December 2017; Revised 1 July 2018; Accepted 22 July 2018; Published 27 September 2018
Academic Editor: Tamer A. Macky
Caption: Figure 1: Study selection process of nonrandomized cohort trials.
Table 1: Characteristics of the studies (n = 9) included in the meta-analysis. Study Site Design Procedure Munoz Spain C Cataract et al. [6] Alio Spain C Cataract et al. [7] Alio Spain C Cataract et al. [8] Rosa et Portugal C Cataract al. [9] Plaza et Spain C Cataract al. [10] Alio et Spain C Cataract al. [11] Alio et Spain C Cataract al. [3, 12] Alfonso Spain C Cataract et al. [13] van der Linden The Netherlands C RLE/cataract et al. [14] Study Included IOL in the IOL in the eyes: experimental control group experimental group group/control group Munoz 40/40 Mplus LS-312 Acri.Lisa 366 et al. [6] MF30 Alio 45/38 Mplus LS-312 Acri.Lisa 366 et al. [7] MF30 Alio 26/31 Mplus LS-312 ReSTOR SN6AD3 et al. [8] MF30 Rosa et 56/44 Mplus LS-312 ResSTOR SN6AD1 al. [9] MF30 Plaza et 30/30 Mplus LS-313 Acri.Smart 48S al. [10] MF30 Alio et 31/35 Mplus LS-312 Crystalens HD al. [11] MF15 Alio et 24/28 Mplus LS-312 Acri.Smart 48S al. [3, 12] MF30 Alfonso 40/40 Mplus LS-312 ResSTOR SN6AD1 et al. [13] MF30 van der Linden 90/143 Mplus LS-312 ResSTOR SN6AD1 et al. [14] MF30 Study Newcastle-Ottawa Follow-up scale scores (months) Munoz Patient 6 et al. [6] selection: 4 Comparability: 2 Outcome assessment: 3 Alio Patient 3 et al. [7] selection: 2 Comparability: 2 Outcome assessment: 3 Alio Patient 3 et al. [8] selection: 4 Comparability: 2 Outcome assessment: 2 Rosa et Patient 3 al. [9] selection: 4 Comparability:2 Outcome assessment: 3 Plaza et Patient 3 al. [10] selection: 4 Comparability: 2 Outcome assessment: 3 Alio et Patient 3 al. [11] selection: 4 Comparability: 2 Outcome assessment: 3 Alio et Patient 3 al. [3, 12] selection: 4 Comparability: 2 Outcome assessment: 3 Alfonso Patient 6 et al. [13] selection: 4 Comparability: 2 Outcome assessment: 3 van der Linden Patient 3 et al. [14] selection: 4 Comparability: 2 Outcome assessment: 3 C = comparative cohort trials; RLE = refractive lens change. Table 2: Summary of the main outcomes included in the meta-analysis. Outcome Risk for Mplus Number of Importance participants (studies) UDVA The intervention 811 (9 studies) CRITICAL group was 0.02 higher (0.01 lower to 0.04 higher) CDVA The intervention 578 (8 studies) CRITICAL group was 0.03 higher (0 to 0.07 higher) UIVA The intervention 438 (6 studies) CRITICAL group was 0.16 lower (0.26 to 0.05 lower) UNVA The intervention 578 (8 studies) CRITICAL group was 0 higher (0.04 lower to 0.04 higher) DCNVA The intervention 578 (8 studies) CRITICAL group was 0.02 lower (0.08 lower to 0.05 higher) CNVA The intervention 258 (4 studies) CRITICAL group was 0.04 higher (0.01 to 0.07 higher) HOA The intervention 258 (4 studies) IMPORTANT group was 0.34 higher (0.15 to 0.53 higher) MTF cut-off The intervention 258 (4 studies) IMPORTANT group was 2.46 lower (4.84 to 0.07 lower) Strehl ratio The intervention 258 (4 studies) IMPORTANT group was 0.4 standard deviations lower (0.65 to 0.15 1) Outcome Quality Comments UDVA (+)(+)(+)(+) See subgroup analysis high in Figure 2(a) CDVA (+)(+)(+)(-) See subgroup analysis moderate in Figure 2(b) UIVA (+)(+)(+)(+) See subgroup analysis high in Figure 3 UNVA (+)(+)(+)(-) See subgroup analysis moderate in Figure 4(a) DCNVA (+)(+)(+)(-)(-) See subgroup analysis moderate in Figure 4(b) CNVA (+)(+)(+)(-)(-) See subgroup analysis low in Figure 4(c) HOA (+)(+)(+)(-) See subgroup analysis high in Figure 5(a) MTF cut-off (+)(+)(+)(-) See subgroup analysis moderate in Figure 5(b) Strehl ratio (+)(+)(+)(-) See subgroup analysis moderate in Figure 5(c) UDVA = uncorrected distance visual acuity; UIVA = uncorrected intermediate visual acuity; UNVA = uncorrected near visual acuity. Table 3: Comparison of defocus curves between the Mplus group and the control group. Study Mplus group Control group Munoz Mplus LS-312 MF30 High-add bifocal et al. [6] IOL: Acri.Lisa 366 Alio et Mplus LS-312 MF30 High-add bifocal al. [7] IOL: Acri.Lisa 366 Alio et Mplus LS-312 MF30 High-add bifocal al. [8] IOL: ReSTOR SN6AD3 Alfonso et Mplus LS-312 MF30 Low-add bifocal al. [13] IOL: ReSTOR SN6AD1 van der Linden Mplus LS-312 MF30 Low-add bifocal et al. [14] IOL: ReSTOR SN6AD1 Alio et Mplus LS-312 MF30 Spherical monofocal al. [3, 12] IOL: Acri.Smart 48S Alio et Mplus LS-312 MF15 Accommodating IOL: al. [11] Crystalens HD Study Mplus IOLs provided Control group better performance provided better performance Munoz In 3, 2.5, 2, 1.5, In -3, -3.5, -4, et al. [6] 1, 0.5, 0, -0.5 *, -1 *, -4.5, -5 D -1.5 *, -2 *, -2.5 * D Alio et In 1.5 *, 1, -1 *, In 0.5, 0, al. [7] -1.5 *, -2 *, -3, -0.5, -2.5 D -3.5, -4, -4.5 D Alio et In 1.5, -1 *, -1.5 *, In 0.5, 1, -0.5, al. [8] -2 *, -2.5 *, -3 *, -4, -4.5 D -3.5 * D Alfonso et In 2, 1.5, 1, In 0.5, 0 *, -0.5 *, al. [13] -1, -1.5, D -2 *, -2.5 *, 3 *, -3.5 *, -4 * D van der Linden In 0, -1.5 D In -2, -2.5 *, et al. [14] -3 * D Alio et In 2.5 *, 2 *, 1.5 *, In -2 *, -2.5 *, al. [3, 12] 1 *, 0.5 *, 0 *, -0.5 *, -3 *, -4, -4.5D -1 *, -1.5 *, -3.5D Alio et In 1.5, 1, 0.5, 0, -- al. [11] -0.5, -1 *, -1.5 *, -2 *, -2.5 *, -3 * D * Significantly different. Table 4: Comparison of contrast sensitivity between the Mplus group and the control group under photopic and low conditions. Conditions Study Mplus group Photopic Alio et al. [7] Mplus LS-312 conditions MF30 Photopic Alio et al. [8] Mplus LS-312 conditions MF30 Photopic Alfonso et al. [13] Mplus LS-312 conditions MF30 Photopic Rosa et al. [9] Mplus LS-312 conditions MF30 Photopic Alio et al. [3, 12] Mplus LS-312 conditions MF30 Photopic Alio et al. [11] Mplus LS-312 conditions MF15 Low conditions Alio et al. [7] Mplus LS-312 MF30 Low conditions Alio et al. [8] Mplus LS-312 MF30 Low conditions Alfonso et al. [13] Mplus LS-312 MF30 Low conditions Rosa et al. [9] Mplus LS-312 MF30 Low conditions Alio et al. [3, 12] Mplus LS-312 MF30 Low conditions Alio et al. [11] Mplus LS-312 MF15 Conditions Control group Mplus IOLs provided better performance Photopic High-add bifocal In 3, 6, 12 *, conditions IOL: Acri.Lisa 366 18 * c/d Photopic High-add bifocal In 3, 6 *, conditions IOL: ReSTOR SN6AD3 12*, 18 *c/d Photopic Low-add bifocal In 6 c/d conditions IOL: ReSTOR SN6AD1 Photopic Spherical monofocal -- conditions IOL: Acri.Smart 48S Photopic Spherical monofocal In 3, 6c/d conditions IOL: Acri.Smart 48S Photopic Accommodating -- conditions IOL: Crystalens HD Low conditions High-add bifocal In 3 c/d IOL: Acri.Lisa 366 Low conditions High-add bifocal In 3, 6, IOL: ReSTOR SN6AD3 12, 18 c/d Low conditions Low-add bifocal In 3, 6, IOL: ReSTOR SN6AD1 12 c/d Low conditions Spherical monofocal -- IOL: Acri.Smart 48S Low conditions Spherical monofocal -- IOL: Acri.Smart 48S Low conditions Accommodating IOL: In 18 c/d Crystalens HD Conditions Control group provided better performance Photopic -- conditions Photopic -- conditions Photopic In 3, 12 *, conditions 18 * c/d Photopic In 0.6, 1.1, conditions 2.2 *, 3.4 *, 7.1 *, 23.6 c/d Photopic In 12, 18 c/d conditions Photopic In 3 *, 6 *, 12 *, conditions 18 * c/d Low conditions In 6, 12, 18 c/d Low conditions -- Low conditions In 18 c/d Low conditions In 0.6, 1.1, 2.2 *, 3.4, 7.1, 23.6 c/d Low conditions In 3, 6, 12, 18 c/d Low conditions In 3, 6, 12 c/d * Significantly different. Figure 2: Meta-analysis of postoperative binocular uncorrected distance visual acuity (UDVA) (a), and corrected distance visual acuity CDVA) (b). SD = standard deviation; CI = confidence interval. (a) Study or subgroup Mplus Control Mean SD Total Mean SD Total 1.2.1. bifocal IOL: high-add Alio1 2012 0.23 0.47 45 0.06 0.05 38 Alio2 2012 0.26 0.51 26 0.1 0.1 31 Munoz 2012 0 0.08 40 0.01 0.05 40 Subtotal (95% CI) 111 109 Heterogeneity: [tau.sup.2] = 0.01; [chi.sup.2] = 8.73, df =2 (P = 0.01); [I.sup.2] = 77% Test for overall effect: Z = 1.20 (P = 0.23) 1.2.2. bifocal IOL: low-add Alfonso 2012 0.03 0.09 40 0.01 0.1 40 Rosa 2013 0.07 0.02 56 0.07 0.01 44 van 2012 0.04 0.15 90 0.06 0.25 143 Subtotal (95% CI) 186 227 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 1.46, df =2 (P = 0.48); [I.sup.2] = 0% Test for overall effect: Z = 0.05 (P = 0.96) 1.2.3. monofocal IOL Alio4 2011 0.25 0.33 24 0.09 0.15 28 Plaza 2016 0.2 0.12 30 0.1 0.32 30 Subtotal (95% CI) 54 58 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.39, df = 1 (P = 0.53); [I.sup.2] = 0% Test for overall effect: Z = 2.64 (P = 0.008) 1.2.4. accommodating IOL Alio3 2012 0.26 0.25 31 0.26 0.45 35 Subtotal (95% CI) 31 35 Heterogeneity: not applicable Test for overall effect: Z = 0.00 (P = 1.00) Total (95% CI) 382 429 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 17.52, df =8 (P = 0.03); [I.sup.2] = 54% Test for overall effect: Z =1.14 (P = 0.25) Test for subgroup differences: [chi.sup.2] = 8.35, df = 3 (P = 0.04); [I.sup.2] = 64.1% Study or subgroup Weight Mean difference IV, random, 95% CI 1.2.1. bifocal IOL: high-add Alio1 2012 3.2% 0.17 (0.03, 0.31) Alio2 2012 1.6% 0.16 (-0.04, 0.36) Munoz 2012 22.8% -0.01 (-0.04, 0.02) Subtotal (95% CI) 27.6% -0.09 (-0.06, 0.23) Heterogeneity: [tau.sup.2] = 0.01; [chi.sup.2] = 8.73, df =2 (P = 0.01); [I.sup.2] = 77% Test for overall effect: Z = 1.20 (P = 0.23) 1.2.2. bifocal IOL: low-add Alfonso 2012 17.6% 0.02 (-0.02, 0.06) Rosa 2013 31.4% 0.00 (-0.01, 0.01) van 2012 14.3% -0.02 (-0.07, 0.03) Subtotal (95% CI) 63.2% 0.00 (-0.01, 0.01) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 1.46, df =2 (P = 0.48); [I.sup.2] = 0% Test for overall effect: Z = 0.05 (P = 0.96) 1.2.3. monofocal IOL Alio4 2011 3.0% 0.16 (0.02, 0.30) Plaza 2016 4.0% 0.10 (-0.02, 0.22) Subtotal (95% CI) 7.0% 0.13 (0.03, 0.22) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.39, df = 1 (P = 0.53); [I.sup.2] = 0% Test for overall effect: Z = 2.64 (P = 0.008) 1.2.4. accommodating IOL Alio3 2012 2.1% 0.00 (-0.17, 0.17) Subtotal (95% CI) 2.1% 0.00 (-0.17, 0.17) Heterogeneity: not applicable Test for overall effect: Z = 0.00 (P = 1.00) Total (95% CI) 100.0% 0.02 (-0.01, 0.04) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 17.52, df = 8 (P = 0.03); [I.sup.2] = 54% Test for overall effect: Z =1.14 (P = 0.25) Test for subgroup differences: [chi.sup.2] = 8.35, df = 3 (P = 0.04); [I.sup.2] = 64.1% (b) Study or subgroup Mplus Control Mean SD Total Mean SD Total 2.3.1. bifocal IOL: high-add Alio1 2012 0.03 0.07 45 0.01 0.02 38 Alio1 2012 0.06 0.13 26 0.02 0.04 31 Munoz 2012 -0.02 0.05 40 -0.01 0.04 40 Subtotal (95% CI) 111 109 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 5.78, df =2 (P = 0.06); [I.sup.2] = 65% Test for overall effect: Z = 0.81 (P = 0.42) 2.3.2. bifocal IOL: low-add Alfonso 2012 0.02 0.06 40 -0.06 0.05 40 Rosa 2013 -0.01 0.01 56 -0.08 0.16 44 Subtotal (95% CI) 96 84 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.14, df = 1 (P = 0.71); [I.sup.2] = 0% Test for overall effect: Z = 7.09 (P < 0.00001) 2.3.3. monofocal IOL Alio4 2011 0.09 0.18 24 0.02 0.05 28 Plaza 2016 0 0.05 30 0.04 0.15 30 Subtotal (95% CI) 54 58 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 5.32, df = 1 (P = 0.02); [I.sup.2] = 81% Test for overall effect: Z = 0.22 (P = 0.82) 2.3.4. accommodating IOL Alio3 2012 0.1 0.16 31 0.04 0.08 35 Subtotal (95% CI) 31 35 Heterogeneity: not applicable Test for overall effect: Z = 1.89 (P = 0.06) Total (95% CI) 292 286 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 43.35, df = 7 (P < 0.00001); [I.sup.2] = 84% Test for overall effect: Z = 2.16 (P = 0.03) Test for subgroup differences: [chi.sup.2] = 15.13, df = 3 (P = 0.002); [I.sup.2] = 80.2% Study or subgroup Weight Mean difference IV, random, 95% CI 2.3.1. bifocal IOL: high-add Alio1 2012 15.6% 0.02 (-0.00, 0.04) Alio1 2012 11.5% 0.04 (-0.01, 0.09) Munoz 2012 15.7% -0.01 (-0.03, 0.01) Subtotal (95% CI) 42.9% 0.01 (-0.02, 0.04) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 5.78, df =2 (P = 0.06); [I.sup.2] = 65% Test for overall effect: Z = 0.81 (P = 0.42) 2.3.2. bifocal IOL: low-add Alfonso 2012 15.3% 0.08 (0.06, 0.10) Rosa 2013 12.2% 0.07 (0.02, 0.12) Subtotal (95% CI) 27.4% 0.08 (0.06, 0.10) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.14, df = 1 (P = 0.71); [I.sup.2] = 0% Test for overall effect: Z = 7.09 (P < 0.00001) 2.3.3. monofocal IOL Alio4 2011 8.7% 0.07 (-0.00, 0.14) Plaza 2016 10.9% -0.04 (-0.10, 0.02) Subtotal (95% CI) 19.6% 0.01 (-0.10, 0.12) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 5.32, df = 1 (P = 0.02); [I.sup.2] = 81% Test for overall effect: Z = 0.22 (P = 0.82) 2.3.4. accommodating IOL Alio3 2012 10.1% 0.06 (-0.00, 0.12) Subtotal (95% CI) 10.1% 0.06 (-0.00, 0.12) Heterogeneity: not applicable Test for overall effect: Z = 1.89 (P = 0.06) Total (95% CI) 100.0% 0.03 (0.00, 0.07) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 43.35, df =7 (P < 0.00001); [I.sup.2] = 84% Test for overall effect: Z = 2.16 (P = 0.03) Test for subgroup differences: [chi.sup.2] = 15.13, df = 3 (P = 0.002); [I.sup.2] = 80.2% Figure 3: Meta-analysis of postoperative binocular uncorrected intermediate visual acuity (UIVA). Study or subgroup Mplus Control Mean SD Total Mean SD 3.2.2. bifocal IOL: high add Alio1 2012 0.12 0.1 45 0.3 0.15 Alio2 2012 0.07 0.09 26 0.32 0.21 Munoz 2012 0.16 0.06 40 0.35 0.07 Subtotal (95% CI) 111 Heterogeneity: [tau.sup.2] = 0.00;[chi.sup.2] =2.12, df = 2 (P = 0.35); [I.sup.2] = 6% Test for overall effect: Z = 14.56 (P < 0.00001) 3.2.3. bifocal IOL: low-add Rosa 2013 0.26 0.02 56 0.26 0.02 Subtotal (95% CI) 56 Heterogeneity: not applicable Test for overall effect: Z = 0.00 (P = 1.00) 3.2.4. monofocal IOL Alio4 2011 0.1 0.13 24 0.22 0.06 Subtotal (95% CI) 24 Heterogeneity: not applicable Test for overall effect: Z = 4.16 (P < 0.0001) 3.2.5. accommodating IOL Alio3 2012 0.16 0.18 31 0.37 0.1 Subtotal (95% CI) 31 Heterogeneity: not applicable Test for overall effect: Z = 5.76 (P < 0.00001) Total (95% CI) 222 Heterogeneity: [tau.sup.2] = 0.02; [chi.sup.2] = 261.35, df = 5 (P<0.00001); [I.sup.2] = 98% Test for overall effect: Z = 2.91 (P = 0.004) Test for subgroup differences: [chi.sup.2] = 234.33, df =3 (P < 0.00001); [I.sup.2] = 98.7% Study or subgroup Weight Mean difference Total IV, random, 95% CI 3.2.2. bifocal IOL: high add Alio1 2012 38 16.7% -0.18 (-0.24, -0.12) Alio2 2012 31 15.8% -0.25 (-0.33, -0.17) Munoz 2012 40 17.3% -0.19 (-0.22, -0.16) Subtotal (95% CI) 109 49.7% -0.19 (-0.22, -0.17) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] =2.12, df = 2 (P = 0.35); [I.sup.2] = 6% Test for overall effect: Z = 14.56 (P < 0.00001) 3.2.3. bifocal IOL: low-add Rosa 2013 44 17.5% 0.00 (-0.01, 0.01) Subtotal (95% CI) 44 17.5% 0.00 (-0.01, 0.01) Heterogeneity: not applicable Test for overall effect: Z = 0.00 (P = 1.00) 3.2.4. monofocal IOL Alio4 2011 28 16.6% -0.12 (-0.18, -0.06) Subtotal (95% CI) 28 16.6% -0.12 (-0.18, -0.06) Heterogeneity: not applicable Test for overall effect: Z = 4.16 (P < 0.0001) 3.2.5. accommodating IOL Alio3 2012 35 16.2% -0.21 (-0.28, -0.14) Subtotal (95% CI) 35 16.2% -0.21 (-0.28, -0.14) Heterogeneity: not applicable Test for overall effect: Z = 5.76 (P < 0.00001) Total (95% CI) 216 100.0% -0.16 (-0.26, -0.05) Heterogeneity: [tau.sup.2] = 0.02; [chi.sup.2] = 261.35, df = 5 (P<0.00001); [I.sup.2] = 98% Test for overall effect: Z = 2.91 (P = 0.004) Test for subgroup differences: [chi.sup.2] = 234.33, df =3 (P < 0.00001); [I.sup.2] = 98.7% Figure 4: Meta-analysis of postoperative binocular uncorrected distance visual acuity (UDVA) (a), distance-corrected near visual acuity (DCNVA) (b), and corrected near visual acuity (CNVA) (c). SD = standard deviation; CI = confidence interval. (a) Study or subgroup Mplus Control Mean SD Total Mean SD 4.1.2. bifocal IOL: high-add Alio1 2012 0.2 0.16 45 0.12 0.11 Alio2 2012 0.21 0.17 26 0.11 0.08 Munoz 2012 0.11 0.08 40 0.06 0.09 Subtotal (95% CI) 111 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 1.80, df = 2 (P = 0.41); [I.sup.2] = 0% Test for overall effect: Z = 4.46 (P < 0.00001) 4.1.3. bifocal IOL: low-add Alfonso 2012 0.11 0.1 40 0.1 0.06 Rosa 2013 0.15 0.02 56 0.16 0.03 Subtotal (95% CI) 96 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 1.09, df = 1 (P = 0.30); [I.sup.2] = 8% Test for overall effect: Z = 1.25 (P = 0.21) 4.1.4. monofocal IOL Alio4 2011 0.2 0.12 30 0.4 0.37 Plaza 2016 0.3 0.21 24 0.49 0.17 Subtotal (95% CI) 54 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.01, df = 1 (P = 0.91); [I.sup.2] = 0% Test for overall effect: Z = 4.53 (P < 0.00001) 4.1.5. accommodating IOL Alio3 2012 0.4 0.19 31 0.42 0.15 Subtotal (95% CI) 31 Heterogeneity: not applicable Test for overall effect: Z = 0.47 (P = 0.64) Total (95% CI) 292 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 45.87, df = 7 (P < 0.00001); [I.sup.2] = 85% Test for overall effect: Z = 0.00 (P = 1.00) Test for subgroup differences: [chi.sup.2] = 42.17, df = 3 (P < 0.00001); [I.sup.2] = 92.9% Study or subgroup Control Weight Total 4.1.2. bifocal IOL: high-add Alio1 2012 38 13.4% Alio2 2012 31 11.9% Munoz 2012 40 15.8% Subtotal (95% CI) 109 41.1% Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 1.80, df = 2 (P = 0.41); [I.sup.2] = 0% Test for overall effect: Z = 4.46 (P < 0.00001) 4.1.3. bifocal IOL: low-add Alfonso 2012 40 15.9% Rosa 2013 44 17.9% Subtotal (95% CI) 84 33.8% Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 1.09, df = 1 (P = 0.30); [I.sup.2] = 8% Test for overall effect: Z = 1.25 (P = 0.21) 4.1.4. monofocal IOL Alio4 2011 30 6.1% Plaza 2016 28 8.5% Subtotal (95% CI) 58 14.5% Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.01, df = 1 (P = 0.91); [I.sup.2] = 0% Test for overall effect: Z = 4.53 (P < 0.00001) 4.1.5. accommodating IOL Alio3 2012 35 10.6% Subtotal (95% CI) 35 10.6% Heterogeneity: not applicable Test for overall effect: Z = 0.47 (P = 0.64) Total (95% CI) 286 100.0% Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 45.87, df = 7 (P < 0.00001); [I.sup.2] = 85% Test for overall effect: Z = 0.00 (P = 1.00) Test for subgroup differences: [chi.sup.2] = 42.17, df = 3 (P < 0.00001); [I.sup.2] = 92.9% (b) Study or subgroup Mplus Control Mean SD Total Mean SD 5.1.2. bifocal 1OL: high-add Aliol 2012 0.23 0.2 45 0.1 0.12 Alio2 2012 0.26 0.22 26 0.09 0.06 Munoz 2012 0.15 0.09 40 0.02 0.07 Subtotal (95% CI) 111 Heterogeneity: [tau.sup.2] = 0.00; [chi.up.2] = 0.72, df = 2 (P = 0.70); [I.sup.2] = 0% Test for overall effect: Z = 8.90 (P < 0.00001) 5.1.3. bifocal 1OL: low-add Alfonso 2012 -0.03 0.06 40 -0.09 0.06 Rosa 2013 0.14 0.02 56 0.15 0.02 Subtotal (95% CI) 96 Heterogeneity: [tau.sup.2] = 0.00; [chi.spu.2] = 24.97, df = 1 (P < 0.00001); [I.sup.2] = 96% Test for overall effect: Z = 0.68 (P = 0.50) 5.1.4. monofocal IOL Alio4 2011 0.17 0.19 24 0.47 0.15 Plaza 2016 0.2 0.12 30 0.58 0.4 Subtotal (95% CI) 54 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.79, df = 1 (P = 0.37); [I.sup.2] = 0% Test for overall effect: Z = 7.94 (P < 0.00001) 5.1.5. accommodating IOL Alio3 2012 0.39 0.14 31 0.48 0.13 Subtotal (95% CI) 31 Heterogeneity: not applicable Test for overall effect: Z =2.70 (P = 0.007) Total (95% CI) 292 Heterogeneity: [tau.sup.2] = 0.01; [chi.sup.2] = 177.19, df =7 (P < 0.00001); [I.sup.2] = 96% Test for overall effect: Z = 0.48 (P = 0.68) Test for subgroup differences: [chi.sup.2 = 133.54, df = 3 (P < 0.00001); [I.sup.2] = 97.8% Study or subgroup Control Weight Mean difference Total IV, random, 95% CI 5.1.2. bifocal 1OL: high-add Aliol 2012 38 12.6% 0.13 (0.06, 0.20) Alio2 2012 31 11.8% 0.17 (0.08, 0.26) Munoz 2012 40 14.0% 0.13 (0.09, 0.17) Subtotal (95% CI) 109 38.4% 0.13 (0.10, 0.16) Heterogeneity: [tau.sup.2] = 0.00; [chi.up.2] = 0.72, df = 2 (P = 0.70); [I.sup.2] = 0% Test for overall effect: Z = 8.90 (P < 0.00001) 5.1.3. bifocal 1OL: low-add Alfonso 2012 40 14.3% 0.06 (0.03, 0.09) Rosa 2013 44 14.5% -0.01 (-0.02, -0.00) Subtotal (95% CI) 84 28.8% 0.02 (-0.04, 0.09) Heterogeneity: [tau.sup.2] = 0.00; [chi.spu.2] = 24.97, df = 1 (P < 0.00001); [I.sup.2] = 96% Test for overall effect: Z = 0.68 (P = 0.50) 5.1.4. monofocal IOL Alio4 2011 28 11.4% -0.30 (-0.39, -0.21) Plaza 2016 30 8.6% -0.38 (-0.53, -0.23) Subtotal (95% CI) 58 20.0% -0.32 (-0.40, -0.24) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.79, df = 1 (P = 0.37); [I.sup.2] = 0% Test for overall effect: Z = 7.94 (P < 0.00001) 5.1.5. accommodating IOL Alio3 2012 35 12.8% -0.09 (-0.16, -0.02) Subtotal (95% CI) 35 12.8% -0.09 (-0.16, -0.02) Heterogeneity: not applicable Test for overall effect: Z =2.70 (P = 0.007) Total (95% CI) 286 100.0% -0.02 (-0.08, 0.05) Heterogeneity: [tau.sup.2] = 0.01; [chi.sup.2] = 177.19, df =7 (P < 0.00001); [I.sup.2] = 96% Test for overall effect: Z = 0.48 (P = 0.68) Test for subgroup differences: [chi.sup.2 = 133.54, df = 3 (P < 0.00001); [I.sup.2] = 97.8% (c) Study or subgroup Mplus Control Mean SD Total Mean SD Total 6.1.1. bifocal IOL: high-add Aliol 2012 0.11 0.12 45 0.07 0.07 Alio2 2012 0.11 0.13 26 0.09 0.06 Subtotal (95% CI) 71 Heterogeneity: [chi.sup.2] = 0.33, df = 1 (P = 0.57); [I.sup.2] = 0% Test for overall affect: Z = 1.94 (P = 0.05) 6.1.2. monofocal IOL Alio4 2011 0.12 0.18 24 0.07 0.17 Subtotal (95% CI) 24 Heterogeneity: not applicable Test for overall affect: Z = 1.02 (P = 0.31) 6.1.3. accommodating IOL Alio3 2012 0.14 0.23 31 0.07 0.06 Subtotal (95% CI) 31 Heterogeneity: not applicable Test for overall affect: Z = 1.65 (P = 0.10) Total (95% CI) 126 Heterogeneity: [chi.sup.2] = 1.06, df =3 (P = 0.79); [I.sup.2] = 0% Test for overall affect: Z =2.61 (P = 0.009) Test for subgroup differences: [chi.sup.2] = 0.73, df =2 (P = 0.70); [I.sup.2] = 0% Study or subgroup Weight Mean difference IV, fixed, 95% CI 6.1.1. bifocal IOL: high-add Aliol 2012 38 49.4% 0.04 (-0.00, 0.08) Alio2 2012 31 29.0% 0.02 (-0.03, 0.07) Subtotal (95% CI) 69 78.4% 0.03 (-0.00, 0.07) Heterogeneity: [chi.sup.2] = 0.33, df = 1 (P = 0.57); [I.sup.2] = 0% Test for overall affect: Z = 1.94 (P = 0.05) 6.1.2. monofocal IOL Alio4 2011 28 9.3% 0.05 (-0.05, 0.15) Subtotal (95% CI) 28 9.3% 0.05 (-0.05, 0.15) Heterogeneity: not applicable Test for overall affect: Z = 1.02 (P = 0.31) 6.1.3. accommodating IOL Alio3 2012 35 12.3% 0.07 (-0.01, 0.15) Subtotal (95% CI) 35 12.3% 0.07 (-0.01, 0.15) Heterogeneity: not applicable Test for overall affect: Z = 1.65 (P = 0.10) Total (95% CI) 132 100.0% 0.04 (0.01, 0.07) Heterogeneity: [chi.sup.2] = 1.06, df =3 (P = 0.79); [I.sup.2] = 0% Test for overall affect: Z =2.61 (P = 0.009) Test for subgroup differences: [chi.sup.2] = 0.73, df =2 (P = 0.70); [I.sup.2] = 0% Figure 5: Meta-analysis of postoperative binocular uncorrected distance visual acuity (UDVA) (a), distance-corrected near visual acuity (DCNVA) (b), and corrected near visual acuity (CNVA) (c). SD = standard deviation; CI = confidence interval. (a) Study or subgroup Mplus Control Mean SD Total Mean SD 7.2.1. bifocal IOL: high-add Alio1 2012 0.83 0.43 45 0.48 0.22 Alio2 2012 0.91 0.41 26 0.48 0.2 Subtotal (95% CI) 71 Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.49, df = 1 (P = 0.49); [I.sup.2] = 0% Test for overall effect: Z = 6.79 (P < 0.00001) 7.2.2. monofocal IOL Alio4 2011 0.97 0.42 24 0.46 0.18 Subtotal (95% CI) 24 Heterogeneity: not applicable Test for overall effect: Z = 5.53 (P < 0.00001) 7.2.3. accommodating IOL Alio3 2012 0.79 0.27 31 0.69 0.23 Subtotal (95% CI) 31 Heterogeneity: not applicable Test for overall effect: Z = 1.61 (P = 0.11) Total (95% CI) 126 Heterogeneity: [tau.sup.2] = 0.03: [chi.sup.2] = 18.18, df = 3 (P = 0.0004); I2 = 83% Test for overall effect: Z = 3.55 (P = 0.0004) Test for subgroup differences: [chi.sup.2] = 17.69, df =2 (P = 0.0001), [I.sup.2] = 88.7% Study or subgroup Control Weight Mean difference Total IV, random, 95% CI 7.2.1. bifocal IOL: high-add Alio1 2012 38 25.6% 0.35 (0.21, 0.49) Alio2 2012 31 24.0% 0.43 (0.26, 0.60) Subtotal (95% CI) 69 49.7% 0.38 (0.27, 0.49) Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.49, df = 1 (P = 0.49); [I.sup.2] = 0% Test for overall effect: Z = 6.79 (P < 0.00001) 7.2.2. monofocal IOL Alio4 2011 28 23.6% 0.51 (0.33, 0.69) Subtotal (95% CI) 28 23.6% 0.51 (0.33, 0.69) Heterogeneity: not applicable Test for overall effect: Z = 5.53 (P < 0.00001) 7.2.3. accommodating IOL Alio3 2012 35 26.8% 0.10 (-0.02, 0.22) Subtotal (95% CI) 35 26.8% 0.10 (-0.02, 0.22) Heterogeneity: not applicable Test for overall effect: Z = 1.61 (P = 0.11) Total (95% CI) 132 100.0% 0.34 (0.15, 0.53) Heterogeneity: [tau.sup.2] = 0.03: [chi.sup.2] = 18.18, df = 3 (P = 0.0004); I2 = 83% Test for overall effect: Z = 3.55 (P = 0.0004) Test for subgroup differences: [chi.sup.2] = 17.69, df =2 (P = 0.0001), [I.sup.2] = 88.7% (b) Study or subgroup Mplus Control Mean SD Total Mean SD Total 8.1.1. bifocal IOL: high-add Alio1 2012 18.31 9.35 45 24.16 7.31 38 Alio2 2012 18.31 9.35 26 21.22 5.29 31 Subtotal (95% CI) 71 69 Heterogeneity: [chi.sup.2] = 1.14, df = 1 (P = 0.29); [I.sup.2] = 12% Test for overall effect: Z = 3.33 (P = 0.0009) 8.1.2. monofocal IOL Alio4 2011 17.31 7.34 24 17.15 5.5 28 Subtotal (95% CI) 24 28 Heterogeneity: not applicable Test for overall effect: Z = 0.09 (P = 0.93) 8.1.3. accommodating IOL Alio3 2012 13.27 4.87 31 14.87 5.71 35 Subtotal (95% CI) 31 35 Heterogeneity: not applicable Test for overall effect: Z = 1.23 (P = 0.22) Total (95% CI) 126 132 Heterogeneity: [chi.sup.2] = 5.96, df = 3 (P = 0.11); [I.sup.2] = 50% Test for overall effect: Z = 2.79 (P = 0.005) Test for subgroup differences: chi2 = 4.82, df = 2 (P = 0.09), [I.sup.2] = 58.5% Study or subgroup Weight Mean difference IV, fixed, 95% CI 8.1.1. bifocal IOL: high-add Alio1 2012 21.0% -5.85 (-9.44, -2.26) Alio2 2012 16.5% -2.91 (-6.96, 1.14) Subtotal (95% CI) 37.5% -4.56 (-7.24, -1.87) Heterogeneity: [chi.sup.2] = 1.14, df = 1 (P = 0.29); [I.sup.2] = 12% Test for overall effect: Z = 3.33 (P = 0.0009) 8.1.2. monofocal IOL Alio4 2011 21.1% 0.16 (-3.41, 3.73) Subtotal (95% CI) 21.1% 0.16 (-3.41, 3.73) Heterogeneity: not applicable Test for overall effect: Z = 0.09 (P = 0.93) 8.1.3. accommodating IOL Alio3 2012 41.4% -1.60 (-4.15, 0.95) Subtotal (95% CI) 41.4% -1.60 (-4.15, 0.95) Heterogeneity: not applicable Test for overall effect: Z = 1.23 (P = 0.22) Total (95% CI) 100.0% -2.34 (-3.98, -0.69) Heterogeneity: [chi.sup.2] = 5.96, df = 3 (P = 0.11); [I.sup.2] = 50% Test for overall effect: Z = 2.79 (P = 0.005) Test for subgroup differences: chi2 = 4.82, df = 2 (P = 0.09), [I.sup.2] = 58.5% (c) Study or subgroup Mplus Control Mean SD Total Mean SD Total 9.2.1. bifocal IOL: high-add Aliol 2012 0.12 0.05 45 0.15 0.04 38 Alio2 2012 0.12 0.05 26 0.13 0.03 31 Subtotal (95% CI) 71 69 Heterogeneity: [chi.sup.2] = 1.79, df = 1 (P = 0.18); [I.sup.2] = 44% Test for overall effect: Z = 2.87 (P = 0.004) 9.2.2. monofocal IOL Alio4 2011 0.11 0.05 24 0.11 0.03 28 Subtotal (95% CI) 24 28 Heterogeneity: not applicable Test for overall effect: Z = 0.00 (P = 1.00) 9.2.3. accommodating IOL Alio3 2012 0.09 0.03 31 0.11 0.04 35 Subtotal (95% CI) 31 35 Heterogeneity: not applicable Test for overall effect: Z = 2.31 (P = 0.02) Total (95% CI) 126 132 Heterogeneity: [chi.sup.2] = 4.36, df =3 (P = 0.23); [I.sup.2] = 31% Test for overall effect: Z = 3.32 (P = 0.0009) Test for subgroup differences: [chi.sup.2] = 2.57, df =2 (P = 0.28); [I.sup.2] = 22.1% Study or subgroup Weight Mean difference IV, fixed, 95% CI 9.2.1. bifocal IOL: high-add Aliol 2012 26.3% -0.03 (-0.05, -0.01) Alio2 2012 20.5% -0.01 (-0.03, -0.01) Subtotal (95% CI) 46.8% -0.02 (-0.04, -0.01) Heterogeneity: [chi.sup.2] = 1.79, df = 1 (P = 0.18); [I.sup.2] = 44% Test for overall effect: Z = 2.87 (P = 0.004) 9.2.2. monofocal IOL Alio4 2011 18.8% 0.00 (-0.02, 0.02) Subtotal (95% CI) 18.8% 0.00 (-0.02, 0.02) Heterogeneity: not applicable Test for overall effect: Z = 0.00 (P = 1.00) 9.2.3. accommodating IOL Alio3 2012 34.4% -0.02 (-0.04, -0.00) Subtotal (95% CI) 34.4% -0.02 (-0.04, -0.00) Heterogeneity: not applicable Test for overall effect: Z = 2.31 (P = 0.02) Total (95% CI) 100.0% -0.02 (-0.03, -0.01) Heterogeneity: [chi.sup.2] = 4.36, df =3 (P = 0.23); [I.sup.2] = 31% Test for overall effect: Z = 3.32 (P = 0.0009) Test for subgroup differences: [chi.sup.2] = 2.57, df = 2 (P = 0.28); [I.sup.2] = 22.1%
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Author: | Xu, Zequan; Li, Wenzhe; Wu, Lianqun; Xue, Shuang; Chen, Xu; Wu, Qiang |
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Publication: | Journal of Ophthalmology |
Geographic Code: | 9CHIN |
Date: | Jan 1, 2018 |
Words: | 11025 |
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