Trifocal versus Bifocal Diffractive Intraocular Lens Implantation after Cataract Surgery or Refractive Lens Exchange: a Meta-analysis

Chang Ho Yoon; In-Soo Shin; Mee Kum Kim

doi:10.3346/jkms.2018.33.e275

Journal List > J Korean Med Sci > v.33(44) > 1107924

Go to TopGo to Top Go to BottomGo to Bottom

TOOLS

Yoon, Shin, and Kim: Trifocal versus Bifocal Diffractive Intraocular Lens Implantation after Cataract Surgery or Refractive Lens Exchange: a Meta-analysis

Original Article

Ophthalmology

Journal of Korean Medical Science 2018; 33(44): e275.

Published online: 27 September 2018

DOI: https://doi.org/10.3346/jkms.2018.33.e275

Trifocal versus Bifocal Diffractive Intraocular Lens Implantation after Cataract Surgery or Refractive Lens Exchange: a Meta-analysis

Chang Ho Yoon^1,²

, In-Soo Shin³

, Mee Kum Kim^1,²

¹Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea.

²Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea.

³Department of Education, Jeonju University College of Education, Jeonju, Korea.

Address for Correspondence: Mee Kum Kim, MD, PhD. Department of Ophthalmology, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul 03080, Korea. kmk9@snu.ac.kr

Received 12 February 2018 Accepted 20 July 2018

The Korean Academy of Medical Sciences

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

We compared the efficacy between trifocal and bifocal diffractive intraocular lens (IOL) implantation.

Methods

Through PubMed, MEDLINE, EMBASE, and CENTRAL, we searched potentially relevant articles published from 1990 to 2018. Defocus curves, visual acuities (VAs) were measured as primary outcomes. Spectacle dependence, postoperative refraction, contrast sensitivity (CS), glare, and higher-order aberrations (HOAs) were measured as secondary outcomes. Effects were pooled using random-effects method.

Results

We included 11 clinical trials, with a total of 787 eyes (395 subjects). The trifocal IOL group showed better binocular distance VA corrected with defocus levels of −0.5, −1.0, −1.5, and −2.5 diopter than the bifocal IOL group (All P ≤ 0.004). The trifocal IOL group showed better monocular uncorrected distance and intermediate VAs (mean difference [MD], −0.04 logarithm of the minimum angle of resolution [logMAR]; 95% confidence interval [CI], −0.07, −0.01; P = 0.006 and MD, −0.07 logMAR; 95% CI, −0.13, −0.01; P = 0.03, respectively). Postoperative refraction, glare, CS, and HOAs were not significantly different from each other.

Conclusion

The overall findings indicate that trifocal diffractive IOL implantation is better than the bifocal diffractive IOL in intermediate VA, and provides similar or better in distance and near VAs without any major deterioration in the visual quality.

Graphical Abstract

Keywords: Bifocal, Diffractive, Intraocular Lens, Meta-analysis, Trifocal

INTRODUCTION

Cataract extraction with intraocular lens (IOL) implantation is an effective method for restoring visual acuity (VA). The traditional IOL design was monofocal, which targeted distance vision in most patients. One of the main factors for dissatisfaction after monofocal IOL implantation is loss of accommodative ability. The bifocal diffractive IOL was later introduced,1 and has been widely used in patients who want to achieve spectacle independence after cataract surgery.

The bifocal diffractive IOL provides better near VA than the monofocal IOL and similar distance VA.2 More subjects achieve spectacle independence with the bifocal diffractive IOL than with the monofocal IOL.2 3 The bifocal diffractive IOL creates two focal points for near and far distances, so intermediate VA is less than near or far VA.4 Intermediate vision is increasingly important for the younger generation who view the computer screen or dashboard. To overcome the weakness in intermediate vision associated with the bifocal diffractive IOL, the trifocal diffractive IOL was recently introduced.5

The trifocal diffractive IOL theoretically achieves improvements in intermediate vision without impairing near and far vision.6 However, experimental studies have reported that bifocal diffractive IOL shows better modulation transfer function than trifocal diffractive IOL at far focal points, but shows varying results at near and intermediate focal points.7 8 9 Clinical studies also showed inconsistent results in distance, intermediate, and near VAs.10 11 12 13 Furthermore, the most of the clinical studies were limited by the small sample size. Thus, we conducted a meta-analysis to compare visual outcomes, between the trifocal and bifocal diffractive IOLs.

METHODS

Literature search

Two independent investigators conducted an extensive literature search on February 08, 2018, in the PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov. We restricted all searches to articles published from 1990 to 2018. The main search keywords were ‘trifocal’ and ‘intraocular lens.’ Detailed search strategy is provided in the Supplementary Table 1.

Eligibility criteria

This meta-analytic study followed the tenets of the Declaration of Helsinki. The inclusion criteria for the selection of studies were as follows: 1) studies conducted in adults (18 years and older) who were underwent trifocal or bifocal diffractive IOL implantation because of cataract or refractive lens exchange; 2) randomized controlled trials (RCTs) or non-randomized comparative studies (NRCSs) that compared between trifocal and bifocal diffractive IOLs; 3) studies that reported postoperative VA or defocus curves; 4) studies that included more than 10 eyes to each study arms; and 5) postoperative follow up were more than 1 month. The exclusion criteria for the selection of studies were as follows: 1) nonpublished articles (e.g., conference proceedings and abstracts); 2) studies not published in English; 3) studies with overlapping cases; 4) use of a refractive procedure (e.g., LASIK); and 5) in vitro studies. As this meta-analysis based on existing studies in the published literature, Institutional Review Board approval was not necessary.

Data extraction

Two independent investigators conducted data extraction using pre-defined data fields. A third investigator reviewed the results and a consensus was reached. Binocular corrected defocus curves and distance, intermediate, and near VAs were measured as primary outcome parameters. If near or intermediate VA was assessed at more than one distance, we selected the data associated with a distance closest to 66 cm and 40 cm for intermediate VA and near VA, respectively. Spectacle dependence, postoperative refractive error, glare, contrast sensitivity (CS), and higher-order aberrations (HOAs) were measured as secondary outcome parameters. For meta-analysis of continuous variables, data were converted to mean ± standard deviation. When standard deviation was reported as zero, we replaced zero value with the largest number expected before rounding (e.g., 0.00 to 0.0049). For studies that presented median, maximum, minimum, and interquartile range values, they were converted to mean and standard deviation values using the method outlined by Wan et al.14 When only graphs were available in a study, we measured the values directly from the figures in ImageJ 1.50i (National Institutes of Health, Bethesda, MD, USA) using the method outlined by Sistrom and Mergo.15 For studies with more than two intervention groups (multi-arm studies), we combined groups to create a single pair-wise comparison by using the methods set out in the Cochrane Handbook for Systematic Reviews of Interventions to avoid double-counting study participants.16 We tried to contact the original authors if the detailed information needed.

Quality assessment

The selected study was independently reviewed by 2 investigators. Discrepancies between reviewers were resolved by consensus or adjudication by the third reviewer. The authors independently assessed the sources of the bias in the studies according to the methods set out in the Cochrane Handbook for Systematic Reviews of Interventions for RCTs and the Newcastle-Ottawa Scale for NRCSs.16 17

Statistical analysis

A random-effects model was used for the data analysis, because the designs of studies were heterogeneous and we wished to generalize results to a large population. The inverse variance method was used for continuous data and the Mantel-Haenszel method was used for dichotomous outcomes. For continuous outcome, we used mean difference (MD) because the studies reported similar outcomes and reported them with same scales (e.g., logarithm of the minimum angle of resolution [logMAR]). For dichotomous outcomes, we calculated a risk ratio (RR). When we combine dichotomous and continuous studies together, we used the method described by Chinn18 to convert continuous data to odds ratio and pooled using the generic inverse-variance method.16 Review Manager software version 5.2 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) was used for meta-analyses. Statistical heterogeneity was tested using the χ² and I² statistic. A P value less than 0.05 was considered statistically significant.

RESULTS

Search results

Fig. 1 shows the search process. We found 240 articles, 99 from PubMed, 108 from EMBASE, 19 from CENTRAL, and 14 from ClinicalTrials.gov. One hundred three studies were duplicated. Of 137 articles, 123 articles were excluded after titles and abstracts evaluation. After 14 articles were reviewed in full text, 1 article was excluded because it represented only mean values19 and two articles13 20 were excluded because their patients were duplicated with the other two studies.21 22 In those two overlapped cases, only the most recent results were used for analysis and some non-duplicated results of excluded studies were used for analysis. Of 11 selected studies, 6 were RCTs11 12 21 22 23 24 and 5 were NRCSs10 25 26 27 28 with a total of 395 subjects and 787 eyes (trifocal: 401 eyes of 201 subjects; bifocal: 386 eyes of 194 subjects). All studies were published between 2014 and 2018. Two NRCSs25 28 which were similar study design and written by same author were included because we personally received reply from corresponding author that patients of those studies were not overlapped. The follow up times varied from 1 to 14.43 and all exams were conducted after 1 month. Table 1 shows the characteristics of the included studies. Mix-and-match method (blended implantation) was performed for bifocal IOL implantation in 3 studies. Quality of the studies was summarized in Supplementary Fig. 1.

Fig. 1

Flow chart showing searching strategy used in selection of publications for inclusion in this meta-analysis.

CENTRAL = Cochrane Central Register of Controlled Trials.

Table 1

Characteristics of included studies

Study, yr	Design	IOL	Add power	Patients, No.	Eyes, No.	Age (Mean ± SD or Median [IQR])	Follow up, mon
Bilbao-Calabuig et al. (2016)23	RCT	FineVision	+1.75 and +3.50 D	12	24	56.3 ± 6.9	3
Bilbao-Calabuig et al. (2016)23	RCT	ReSTOR SN6AD2 (dominant distance eye) and SN6AD1 (contralateral eye)	+2.50 D (SN6AD2), +3.00 D (SN6AD1)	11	22	56.3 ± 6.9	3
Brito et al. (2015)10	NRCS	AT LISA tri 839 M	+1.66 and +3.33 D	17	33	57.9 ± 6.6	10.27 ± 4.16
Brito et al. (2015)10	NRCS	AT LISA toric 909 MP	+3.75 D	8	15	57.1 ± 11.3	7.13 ± 3.48
Cochener (2016)24	RCT	FineVision	+1.75 and +3.50 D	15	30	58.7 ± 6.4	5.07 ± 1.4
Cochener (2016)24	RCT	ZMB00	+4.00 D	12	24	60.6 ± 9.1	3.42 ± 1.16
Gundersen and Potvin (2016)12	RCT	FineVision toric	+1.75 and +3.50 D	11	22	62.1 ± 7.5	3
Gundersen and Potvin (2016)12	RCT	ReSTOR SND1T	+3.00 D	11	22	70.2 ± 7.8	3
Gundersen and Potvin (2016)27	NRCS	AT LISA tri 839 MP	+1.66 and +3.33 D	25	50	53 ± 8	14.43 ± 7.23
Gundersen and Potvin (2016)27	NRCS	ReSTOR SV25T0 (dominant distance eye) and SN6AD1 (contralateral eye)	+2.50 D (SV25T0), +3.00 D (SN6AD1)	30	60	65 ± 9	13.7 ± 8.6
Jonker et al. (2015)11	RCT	FineVision	+1.75 and +3.50 D	15	30	62.6 ± 8.7	6
Jonker et al. (2015)11	RCT	ReSTOR SN6AD1	+3.00 D	13	26	64.0 ± 8.8	6
Kaymak et al. (2017)21	RCT	AT LISA tri 839 MP	+1.66 and +3.33 D	16	32	62.5 ± 6.9	12
		AT LISA 809 M,	+3.75 D	19	38	64.4 ± 7.5
		ReSTOR SN6AD1	+3.00 D	17	34	42.4 ± 8.9
Mojzis et al. (2017)22	RCT	AT LISA tri 839 MP	+1.66 and +3.33 D	20	40	44–70	12
Mojzis et al. (2017)22	RCT	AT LISA 801	+3.75 D	18	35	44–70	12
Plaza-Puche and Alio (2016)25	NRCS	AT LISA tri 839 MP	+1.66 and +3.33 D,	15	30	63.07 ± 9.66	3
		FineVision	+1.75 and +3.50 D	15	30	66.78 ± 6.20
		ReSTOR SN6AD1	+3.00 D	15	30	62.15 ± 10.27
Plaza-Puche et al. (2016)28	NRCS	AT LISA tri 839 MP	+1.66 and +3.33 D,	15	30	63 (19.00)	3
		FineVision	+1.75 and +3.50 D	15	30	68 (7.50)
		Acri.Lisa 366D	+3.75 D,	15	30	61 (14.50)
		ReSTOR SN6AD1	+3.00 D	15	30	62 (17.75)
Vilar et al. (2017)26	NRCS	PanOptix	+2.17 and +3.25 D	10	20	64.2 ± 8.34	1
Vilar et al. (2017)26	NRCS	ReSTOR SV25T0 (dominant distance eye) and SN6AD1 (contralateral eye)	+2.50 D (SV25T0), +3.00 D (SN6AD1)	10	20	61.9 ± 4.45	1

IOL = intraocular lens, SD = standard deviation, IQR = interquartile range, RCT = randomized controlled trial, NRCS = non-randomised controlled study, D = diopter.

Primary outcomes

Defocus curves

Seven studies11 12 22 23 25 26 27 reported postoperative binocular distance corrected defocus curves (Fig. 2). One study24 that did not describe the condition of examination (binocular/monocular and corrected/uncorrected) was excluded from the analysis. We tried to contact the corresponding author but did not receive a reply. The trifocal IOL group showed better VA in defocus levels of −0.5 (MD, −0.03 logMAR; 95% confidence interval [CI], −0.05, −0.01; P = 0.001), −1.0 (MD, −0.10 logMAR; 95% CI, −0.13, −0.07; P < 0.001), −1.5 (MD, −0.08 logMAR; 95% CI, −0.09, −0.07; P < 0.001), and −2.5 diopter (D) (MD, −0.02 logMAR; 95% CI, −0.04, −0.01; P = 0.004) than the bifocal IOL group.

Fig. 2

Forest plot of trifocal versus bifocal diffractive IOL: binocular corrected defocus curves.

IOL = intraocular lens, MD = mean difference, SD = standard deviation, IV = inverse variance, CI = confidence interval, D = diopter.

Postoperative VA

Monocular VA

The meta-analysis results for monocular VA outcomes are summarized in Fig. 3A. Nine10 11 12 22 24 25 26 27 28 and four11 22 26 27 studies reported monocular uncorrected distance VA and intermediate VA (UDVA and UIVA), respectively. Meta-analysis showed that the trifocal IOL group was better VA than the bifocal IOL group in monocular UDVA and UIVA (MD, −0.04 logMAR; 95% CI, −0.07, −0.01; P = 0.006 and MD, −0.07 logMAR; 95% CI, −0.13, −0.01; P = 0.03, respectively). Seven10 11 22 24 25 26 27 studies reported monocular uncorrected near VA (UNVA). Meta-analysis showed no significant differences in monocular UNVA. Ten,10 11 12 22 23 24 25 26 27 28 three,11 22 27 and seven10 11 22 24 25 26 27 studies reported monocular corrected distance VA (CDVA), distance corrected intermediate and near VA (DCIVA and DCNVA), respectively. Meta-analysis showed no significant differences in monocular CDVA (MD, −0.01 D; 95% CI, −0.02–0.00; P = 0.05), DCIVA (MD, −0.06 D; 95% CI, −0.18–0.05; P = 0.29), and DCNVA (MD, 0.00 D; 95% CI, −0.00–0.00; P = 0.90) between the two groups.

Fig. 3

Forest plot of trifocal versus bifocal diffractive IOL: (A) monocular VAs and (B) the number of patients who did not achieve binocular UIVA of 0.1 logMAR.

IOL = intraocular lens, VA = visual acuity, UDVA = uncorrected distance visual acuity, UIVA = uncorrected intermediate visual acuity, UNVA = uncorrected near visual acuity, logMAR = logarithm of the minimum angle of resolution, SD = standard deviation, MD = mean difference, IV = inverse variance, CI = confidence interval, M-H = Mantele-Haenszel, RR = risk ratio.

Binocular VA

Four studies11 12 21 24 reported binocular UDVA, UIVA, and UNVA. Meta-analysis showed no significant differences in binocular UDVA (MD, −0.02 logMAR; 95% CI, −0.04–0.01; P = 0.21), UIVA (MD, −0.03 logMAR; 95% CI, −0.07–0.01; P = 0.15), and UNVA (MD, 0.00 logMAR; 95% CI, −0.00–0.00; P = 0.97). Three,11 12 21 two,11 21 and two11 21 studies reported binocular CDVA, DCIVA, and DCNVA, respectively. Meta-analysis showed no significant differences in binocular CDVA (MD, −0.01 logMAR; 95% CI, −0.03–0.01; P = 0.57), DCIVA (MD, 0.01 logMAR; 95% CI, −0.11–0.14; P = 0.83) and DCNVA (MD, 0.01 logMAR; 95% CI, −0.07–0.08; P = 0.84) between the two groups. Two studies12 24 reported the prevalence of binocular UIVA of 0.1 logMAR or better as a good visual outcome. The proportion of patients who did not achieve binocular UIVA of 0.1 logMAR was lower in the trifocal IOL (7.7%) than in the bifocal IOL (43.5%) (RR, 0.18; 95% CI, 0.04–0.75; P = 0.02) (Fig. 3B).

Secondary outcomes

Spectacle dependence

Two studies12 24 reported spectacle dependence. The number of patients who required spectacles was not different between the two groups (trifocal IOL group [10.0%]; bifocal IOL group [29.2%]; RR, 0.38; 95% CI, 0.13–−1.13; P = 0.08).

Postoperative refractive error

Five,10 13 24 25 28 eight,10 11 12 13 24 25 27 28 and six11 12 13 23 26 27 studies reported postoperative sphere, cylinder, and spherical equivalent results, respectively. The meta-analysis results showed that sphere (MD, 0.09 D; 95% CI, −0.06–0.24; P = 0.22), cylinder (MD, 0.07 D; 95% CI, 0.00–0.14; P = 0.05), and spherical equivalent (MD, 0.05 D; 95% CI, −0.08–0.17; P = 0.47) were not significantly different between the two groups.

CS

Binocular CS under photopic and mesopic condition reported in four11 20 22 26 and five11 20 22 23 26 studies. Meta-analysis showed no significant differences in 3, 6, 12, and 18 cycles per degree between the two groups (Fig. 4A and B).

Fig. 4

Forest plot of trifocal versus bifocal diffractive IOL: binocular CS under photopic (A) and mesopic (B) conditions; and glare (C).

IOL = intraocular lens, MD = mean difference, CS = contrast sensitivity, SD = standard deviation, IV = inverse variance, CI = confidence interval, SE = standard error, OR = odds ratio.

Glare

Two studies11 24 reported glare symptom. The pooled RR was not significantly different between the two groups (RR, 1.41; 95% CI, 0.51–3.87; P = 0.51) (Fig. 4C).

HOAs

Two studies13 24 reported coma, trefoil, and spherical aberration. Meta-analysis showed no significant differences in coma (MD, −0.02; 95% CI, −0.04–0.01; P = 0.16), trefoil (MD, −0.00; 95% CI, −0.04–0.04; P = 0.98), and spherical aberration (MD, 0.04; 95% CI, −0.04–0.12; P = 0.32) between the two groups.

DISCUSSION

The initial bifocal diffractive IOL was designed with +4.0 D add power. Afterwards, bifocal diffractive IOL with +3.0 D add power was introduced in order to improve intermediate VA.29 30 However, the bifocal diffractive IOL was intrinsically designed to focus on near and far distances and had limitations in intermediate VA.31 32 The trifocal diffractive IOL was developed to overcome the poor intermediate vision of the bifocal diffractive IOL by using 3 different focuses (far, intermediate, and near).6

In this analysis, the trifocal IOL group had better visual outcomes in binocular corrected defocus levels of −0.5, −1.0, −1.5, and −2.5 D. As the trifocal diffractive IOL has an inherent IOL design to improve intermediate distance vision, it would be expected that the trifocal IOL group showed better results in defocus levels of −0.5, −1.0, and −1.5 D, which correspond to distances of 2.0 m, 1.0 m, and 67 cm of VAs, respectively.25 Interestingly, the trifocal IOL group showed better or comparable outcomes compared to the bifocal IOL group for defocus levels of −2.5 D and −3.0 D, respectively. Although we do not know the exact mechanism of this phenomenon, we suggested some plausible explanations and added relevant sentences in the Discussion section as follows: 1) There were 3 studies that used the mix-and-match method (blended implantation) for the bifocal IOL implantation. The add power (the focal point) was different in each eye of the bifocal IOL groups. Therefore, it may affect the binocular near vision. When those 3 mix-and-match studies were excluded, the trifocal IOL group showed no statistical difference in defocus levels of −2.5 D and −3.0 D, when compared to the bifocal IOL group. We added this result as one of the explanations in the Discussion section and in Supplementary Fig. 2. 2) Binocular testing using defocus curve may affect near vision in a better way than trifocal IOL, although bifocal IOL has more strength in monocular near vision. 3) Another possible reason is that longitudinal chromatic aberration (LCA). LCA for near of trifocal IOL in one study33 may be smaller than that of bifocal IOL in other studies.34 35 Nevertheless, given that MD in defocus level of −2.5 D was −0.02 logMAR, indicates less than a line difference in decimal scale of the Snellen chart at near vision, which seems to be clinically irrelevant. This outcome in our study corresponds to a previous study that showed comparable outcome in near VA between trifocal and bifocal IOLs.36

The trifocal IOL group showed a better outcome in monocular UDVA and UIVA. More patients achieved binocular UIVA < 0.1 logMAR in trifocal IOL group. However, there were no significant differences in monocular UNVA, CDVA, DCIVA and DCNVA, and all binocular VAs. Monocular UDVA was better in the trifocal group than in the bifocal group. However, this difference was small (MD, −0.04 logMAR) and most studies accomplished mean monocular UDVA less than 0.1 logMAR. It might be due to less astigmatism in the trifocal group than in bifocal group, although it was not significant (MD, 0.07 D; 95% CI, 0.00–0.14; P = 0.05). Together with the results of defocus curves and VA, the trifocal diffractive IOL is better than the bifocal diffractive IOL in terms of intermediate VA and is comparable in near and distance VAs.

Regarding spectacle independence, bifocal diffractive IOLs have resulted in less spectacle dependence than monofocal IOLs.37 The trifocal IOL group showed better results than the bifocal IOL groups but this was not significant. We pooled data from only two studies with a total of 54 subjects. Further study might be needed to confirm this result.

Regarding the quality of vision, glare, a positive dysphotopsia, is one of the factors related with dissatisfaction after multifocal IOL implantation. Glare has been reported more in diffractive IOLs than in monofocal IOLs38 and some patients wanted to IOL exchange procedure after multifocal IOL implantation because of this phenomenon.39 In this analysis, the trifocal IOL group was not different from the bifocal IOL group in glare phenomenon. Reduction of CS is also the cause of a decrease in quality of vision and has been reported with the diffractive IOL37 because it divides light into several focuses and forms several images of an object at a certain distance.40 Bifocal IOLs included in this study have an asymmetrical light distribution of 50% to 70% for distance focus and 18% to 50% for near focus.23 Trifocal IOLs included in this study have light distribution of 42% to 50% for distance focus, 14% to 20% for intermediate focus, and 29% to 30% for near focus.23 32 Although the trifocal diffractive IOL has more number of focuses and less light energy, the trifocal IOL group was not different from the bifocal IOL group in CS.

There were several limitations in this analysis. First, our study was based on 11 studies restricted to articles published in English. We did not search unpublished studies or abstracts of relevant conference meetings. Second, the studies included in this study evaluated VA at various intermediate (60, 66, 70, and 80 cm) and near (33 and 40 cm) distances. Heterogeneity was high in monocular and binocular VAs. Third, the conditions of VA varied (e.g., corrected/uncorrected or monocular/binocular) so that most meta-analyses did not include all 11 studies. Fourth, given that 3 studies of the bifocal IOL group, with blended implantation to strengthen the binocular intermediate vision, were included, it may affect the outcome of near vision.

Previously, two meta-analysis were reported favorable aspect of trifocal diffractive IOL.36 41 After then, two RCTs21 22 and one NRCS26 have been reported, and we analyzed various outcomes, including the results of these studies. To the best of our knowledge, this is the largest evidence-based meta-analysis comparing trifocal and bifocal diffractive IOLs. In summary, this meta-analysis found that the trifocal diffractive IOL showed better intermediate VA than the bifocal diffractive IOL. Near and distance VAs of the trifocal diffractive IOL are comparable with those of the bifocal diffractive IOL. The quality of vision like glare, CS, and HOAs were also similar between the two groups.

ACKNOWLEDGMENTS

We thank Dr. Soraya M.R. Jonker, University Eye Clinic Maastricht, Maastricht University Medical Center, the Netherlands, for providing data of glare.

Notes

^Disclosure The authors have no potential conflicts of interest to disclose.

^{Author Contributions}

Conceptualization: Kim MK.
Data curation: Yoon CH, Shin I.
Formal analysis: Yoon CH, Shin I.
Methodology: Yoon CH, Shin I, Kim MK.
Software: Yoon CH, Shin I.
Validation: Shin I, Kim MK.
Writing - original draft: Yoon CH.
Writing - review & editing: Shin I, Kim MK.

References

1. Keates RH, Pearce JL, Schneider RT. Clinical results of the multifocal lens. J Cataract Refract Surg. 1987; 13(5):557–560.

2. Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Sao Paulo Med J. 2015; 133(1):68.

3. Shah S, Peris-Martinez C, Reinhard T, Vinciguerra P. Visual outcomes after cataract surgery: multifocal versus monofocal intraocular lenses. J Refract Surg. 2015; 31(10):658–666.

4. Lane SS, Morris M, Nordan L, Packer M, Tarantino N, Wallace RB 3rd. Multifocal intraocular lenses. Ophthalmol Clin North Am. 2006; 19(1):89–105.

5. Voskresenskaya A, Pozdeyeva N, Pashtaev N, Batkov Y, Treushnicov V, Cherednik V. Initial results of trifocal diffractive IOL implantation. Graefes Arch Clin Exp Ophthalmol. 2010; 248(9):1299–1306.

6. Gatinel D, Pagnoulle C, Houbrechts Y, Gobin L. Design and qualification of a diffractive trifocal optical profile for intraocular lenses. J Cataract Refract Surg. 2011; 37(11):2060–2067.

7. Montés-Micó R, Madrid-Costa D, Ruiz-Alcocer J, Ferrer-Blasco T, Pons AM. In vitro optical quality differences between multifocal apodized diffractive intraocular lenses. J Cataract Refract Surg. 2013; 39(6):928–936.

8. Madrid-Costa D, Ruiz-Alcocer J, Ferrer-Blasco T, García-Lázaro S, Montés-Micó R. Optical quality differences between three multifocal intraocular lenses: bifocal low add, bifocal moderate add, and trifocal. J Refract Surg. 2013; 29(11):749–754.

9. Papadatou E, Del Águila-Carrasco AJ, Esteve-Taboada JJ, Madrid-Costa D, Montés-Micó R. Assessing the in vitro optical quality of presbyopic solutions based on the axial modulation transfer function. J Cataract Refract Surg. 2016; 42(5):780–787.

10. Brito P, Salgado-Borges J, Neves H, Gonzalez-Meijome J, Monteiro M. Light-distortion analysis as a possible indicator of visual quality after refractive lens exchange with diffractive multifocal intraocular lenses. J Cataract Refract Surg. 2015; 41(3):613–622.

11. Jonker SM, Bauer NJ, Makhotkina NY, Berendschot TT, van den Biggelaar FJ, Nuijts RM. Comparison of a trifocal intraocular lens with a +3.0 D bifocal IOL: results of a prospective randomized clinical trial. J Cataract Refract Surg. 2015; 41(8):1631–1640.

12. Gundersen KG, Potvin R. Comparison of visual outcomes after implantation of diffractive trifocal toric intraocular lens and a diffractive apodized bifocal toric intraocular lens. Clin Ophthalmol. 2016; 10:455–461.

13. Mojzis P, Kukuckova L, Majerova K, Liehneova K, Piñero DP. Comparative analysis of the visual performance after cataract surgery with implantation of a bifocal or trifocal diffractive IOL. J Refract Surg. 2014; 30(10):666–672.

14. Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014; 14(1):135.

15. Sistrom CL, Mergo PJ. A simple method for obtaining original data from published graphs and plots. AJR Am J Roentgenol. 2000; 174(5):1241–1244.

16. Shinichi A. Cochrane handbook for systematic reviews of interventions. Online Kensaku. 2014; 35(3):154–155.

17. Wells GA, Shea B, O'Connell D, Peterson J, Welch V, Losos M, et al. http://www.ohri.ca/Programs/clinical_epidemiology/oxford.asp. Accessed Oct 19, 2016.

18. Chinn S. A simple method for converting an odds ratio to effect size for use in meta-analysis. Stat Med. 2000; 19(22):3127–3131.

19. Postolache C, Postolache O. Comparation of refractive results with bifocal implants at Lisa 809 and trifocal at Lisa tri839. Rom J Ophthalmol. 2015; 59(2):100–102.

20. Alió JL, Kaymak H, Breyer D, Cochener B, Plaza-Puche AB. Quality of life related variables measured for three multifocal diffractive intraocular lenses: a prospective randomised clinical trial. Clin Exp Ophthalmol. 2018; 46(4):380–388.

21. Kaymak H, Breyer D, Alió JL, Cochener B. Visual performance with bifocal and trifocal diffractive intraocular lenses: a prospective three-armed randomized multicenter clinical trial. J Refract Surg. 2017; 33(10):655–662.

22. Mojzis P, Kukuckova L, Majerova K, Ziak P, Piñero DP. Postoperative visual performance with a bifocal and trifocal diffractive intraocular lens during a 1-year follow-up. Int J Ophthalmol. 2017; 10(10):1528–1533.

23. Bilbao-Calabuig R, González-López F, Amparo F, Alvarez G, Patel SR, Llovet-Osuna F. Comparison between mix-and-match implantation of bifocal intraocular lenses and bilateral implantation of trifocal intraocular lenses. J Refract Surg. 2016; 32(10):659–663.

24. Cochener B. Prospective clinical comparison of patient outcomes following implantation of trifocal or bifocal intraocular lenses. J Refract Surg. 2016; 32(3):146–151.

25. Plaza-Puche AB, Alio JL. Analysis of defocus curves of different modern multifocal intraocular lenses. Eur J Ophthalmol. 2016; 26(5):412–417.

26. Vilar C, Hida WT, de Medeiros AL, Magalhães KRP, de Moraes Tzelikis PF, Chaves MAPD, et al. Comparison between bilateral implantation of a trifocal intraocular lens and blended implantation of two bifocal intraocular lenses. Clin Ophthalmol. 2017; 11:1393–1397.

27. Gundersen KG, Potvin R. Comparison of visual outcomes and subjective visual quality after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of apodized diffractive bifocal intraocular lenses. Clin Ophthalmol. 2016; 10:805–811.

28. Plaza-Puche AB, Alio JL, Sala E, Mojzis P. Impact of low mesopic contrast sensitivity outcomes in different types of modern multifocal intraocular lenses. Eur J Ophthalmol. 2016; 26(6):612–617.

29. Liu JW, Haw WW. Optimizing outcomes of multifocal intraocular lenses. Curr Opin Ophthalmol. 2014; 25(1):44–48.

30. de Vries NE, Webers CA, Montés-Micó R, Ferrer-Blasco T, Nuijts RM. Visual outcomes after cataract surgery with implantation of a +3.00 D or +4.00 D aspheric diffractive multifocal intraocular lens: comparative study. J Cataract Refract Surg. 2010; 36(8):1316–1322.

31. Cochener B, Vryghem J, Rozot P, Lesieur G, Heireman S, Blanckaert JA, et al. Visual and refractive outcomes after implantation of a fully diffractive trifocal lens. Clin Ophthalmol. 2012; 6:1421–1427.

32. Marques EF, Ferreira TB. Comparison of visual outcomes of 2 diffractive trifocal intraocular lenses. J Cataract Refract Surg. 2015; 41(2):354–363.

33. Vinas M, Gonzalez-Ramos A, Dorronsoro C, Akondi V, Garzon N, Poyales F, et al. In vivo measurement of longitudinal chromatic aberration in patients implanted with trifocal diffractive intraocular lenses. J Refract Surg. 2017; 33(11):736–742.

34. Millán MS, Vega F, Ríos-López I. Polychromatic image performance of diffractive bifocal intraocular lenses: longitudinal chromatic aberration and energy efficiency. Invest Ophthalmol Vis Sci. 2016; 57(4):2021–2028.

35. Millán MS, Vega F. Extended depth of focus intraocular lens: chromatic performance. Biomed Opt Express. 2017; 8(9):4294–4309.

36. Shen Z, Lin Y, Zhu Y, Liu X, Yan J, Yao K. Clinical comparison of patient outcomes following implantation of trifocal or bifocal intraocular lenses: a systematic review and meta-analysis. Sci Rep. 2017; 7(1):45337.

37. de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016; 12:CD003169.

38. Chiam PJ, Chan JH, Aggarwal RK, Kasaby S. ReSTOR intraocular lens implantation in cataract surgery: quality of vision. J Cataract Refract Surg. 2006; 32(9):1459–1463.

39. de Vries NE, Webers CA, Touwslager WR, Bauer NJ, de Brabander J, Berendschot TT, et al. Dissatisfaction after implantation of multifocal intraocular lenses. J Cataract Refract Surg. 2011; 37(5):859–865.

40. Cetinkaya S, Dadaci Z, Acir NO, Cetinkaya YF, Yener HI, Ozcimen M. Visual outcomes of multifocal intraocular lens implantation in patients with cataract and high hyperopia and patient selection. Int J Ophthalmol. 2015; 8(6):1258–1260.

41. Xu Z, Cao D, Chen X, Wu S, Wang X, Wu Q. Comparison of clinical performance between trifocal and bifocal intraocular lenses: a meta-analysis. PLoS One. 2017; 12(10):e0186522.

SUPPLEMENTARY MATERIALS

Supplementary Table 1

Detailed search strategy

Supplementary Fig. 1

Summary of quality of the studies: (A) randomized controlled studies by Cochrane risk of bias tool, (B) non-randomized controlled studies by Newcastle-Ottawa Scale.

Supplementary Fig. 2

Forest plot of the binocular corrected defocus curves: subgroup analysis after exclusion of the 3 studies that used the mix-and-match method.

TOOLS

ORCID iDs

Chang Ho Yoon
https://orcid.org/0000-0003-2203-5709

In-Soo Shin
https://orcid.org/0000-0001-7535-3511

Mee Kum Kim
https://orcid.org/0000-0001-7850-6894

Similar articles