Comparison of Postoperative Visual Performance Between Bifocal and Trifocal Intraocular Lens Based on Randomized Controlled Trails: A Meta-Analysis

doi:10.21203/rs.1.10/v2

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Comparison of Postoperative Visual Performance Between Bifocal and Trifocal Intraocular Lens Based on Randomized Controlled Trails: A Meta-Analysis

https://doi.org/10.21203/rs.1.10/v2

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published 14 Mar, 2019

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Background：To compare the clinical performance of bifocal and trifocal intraocular lenses (IOLs) in cataract surgery, a meta-analysis on randomized controlled trials was conducted.

Methods: A comprehensive literature retrieval of PubMed, Science Direct and EMBASE was performed in this systematic review. Clinical outcomes included visual acuity (VA), contrast sensitivity (CS), spectacle independence, postoperative refraction and surgical satisfaction.

Results: There were 8 RCTs included in this study. The difference of uncorrected near VA (UNVA) between the bifocal IOLs and trifocal IOLs had no clinical significance [MD=-0.01, 95%CI: (-0.02,0.00), p=0.97]. There was no difference for the distant-corrected near VA (DCNVA) with MD of 0.01[95%CI (-0.02, 0.05), p=0.86]. Compared with trifocal group, bifocal group showed a significantly worse uncorrected intermediate visual acuity (UIVA) [MD=0.09,95%CI:(0.01,0.17), p＜0.01]. No difference was found in distance-corrected intermediate VA(DCIVA) [MD= 0.09, 95%CI: (-0.04, 0.23) , p＜0.01] between two groups. For the AT LISA group, the subgroup analysis also indicated the bifocal group had worse intermediate VA than trifocal group (AT LISA tri 839M) [MD= 0.18, 95%CI: (0.12, 0.24), p=0.35 for UIVA and MD= 0.19, 95%CI: (0.13, 0.25), p=0.21 for DCIVA]. However, there was no statistically significant difference between the two groups in the uncorrected distance VA(UDVA) and corrected distance visual acuity (CDVA) [MD=0.01, 95%CI: (-0.01,0.04), p=0.51 for UDVA; MD=0.00, 95%CI: (-0.01,0.01), p=0.94 for CDVA].

The postoperative refraction of bifocal group was similar to that of trifocal group [MD=-0.08, 95% CI: (-0.19, 0.03), p=0.51 for spherical equivalent; MD=-0.09, 95%CI: (-0.21, 0.03), p=0.78 for cylinder; MD=-0.09, 95% CI: (-0.27, 0.08), p=0.28 for sphere]. No difference was found for spectacle independence, Posterior capsular opacification (PCO) incidence and patient satisfaction between bifocal IOLs and trifocal IOLs. [RR=0.89, 95% CI: (0.71, 1.12), p=0.69 for spectacle independence; RR=0.81, 95% CI: (0.74, 1.15), p=0.65 for PCO; RR=0.98, 5% CI: (0.86, 1.12), p=0.97 for satisfaction].

Conclusion: Patients receiving trifocal IOLs have a better intermediate VA than bifocal IOLs, especially for the AT LISA subgroup. Near and distance visual performance, spectacle independence, postoperative refraction and surgical satisfaction of bifocal IOLs were similar to those of trifocal IOLs.

Internal Medicine Specialties

bifocal

trifocal

intraocular lenses

cataract surgery

randomized

IOLs

meta-analysis

Cataract is clouding of the normally clear crystalline lens or loss of transparency, which reduces the amount of incoming light and impairs visual perception, and it is the leading cause of vision impairment and blindness worldwide. Data from the World Health Organization (WHO) showed that cataract account for approximately 50% of blind suffer in world[1]. In China, blindness or low vision affects about 5.8% of Chinese aged 50 and above[2]. Given the rapid population aging and high prevalence of age-related cataract (ARC) in China, especially in rural areas[3, 4], it is expected that an increasing number of populations will suffer from cataract.

It is generally acknowledged that cataract surgery is the most cost-effective way for restoring vision. Harold Ridley performed the first cataract extraction with implantation of an intraocular lens (IOLs) in London in 1949. Nowadays, cataract surgery has been modified into a highly specialized procedure, and the IOLs technique has also been developing constantly[5]. After the monofocal IOLs implemented, other IOLs such as multifocal IOLs (diffractive, refractive) and accommodating type of IOLs, were successively devised to correct not only cloudy lens but also astigmatism and presbyopia. Nowadays, the most commonly used multifocal IOLs in clinical practice are bifocal and trifocal IOLs. Therefore, the aim of this systematic review is to compare the clinical visual performance of bifocal and trifocal IOLs, thereby providing solid evidence for better clinical practice.

Search strategy and Inclusion criteria

Inclusion and exclusion criteria: 1. the study subjects should patients with age-related cataract (P) who received cataract extraction with bifocal (I) or trifocal intraocular lens (c) implantation. The visual performance was evaluated as visual acuity (VA) including uncorrected, correct and distance-correct (near, intermediate and far) performance, refraction cylinder, spherical equivalent refraction, spectacle independence, and patient satisfaction after cataract surgery (O); 2. only randomized controlled clinical trials were included; 3. studies without detailed outcome of postoperative visual performance of patient were excluded; 4. Non-English publications were excluded.

Search strategy: A comprehensive search strategy for the following databases: PubMed, Science direct and EMBASE was conducted. Literature published after 2007 was included, and searches were conducted between October 2017 and January 2018.One or a combination of the following terms was used in the search: intraocular lenses, IOL, bifocal, trifocal, cataract surgery, comparison, random. Details of the search strategy are available in Appendix # [see Additional file 2]. Two investigators (Shanshan Jin and Kai Cao) conducted the article screening independently. We will make a discussion or ask the third reviewer give a decision until a consensus was reached, if there was any doubt as to the eligibility of a study.

Data extraction

Data were independently extracted from each study by two investigators using pre-defined data fields. Data on visual acuity reported as log MAR VA were measured as the primary outcome. We will extract the data of near VA and intermediate VA at distance of 40 cm and 66 cm respectively if the VA was measured at more than one distance. Data on spectacle independence, spherical equivalent refraction refractive cylinder and surgical complications were collected as the second outcomes. For studies with more than one postoperative follow-up interval, the data of last follow-up were extracted. Mean ± SD was extracted for continuous data, and for categorical data, the proportions of patients reporting surgical complications and no need for spectacles were extracted and recorded as a percentage. In studies involving multiple groups, the sample size of control group was divided by the number of intervention groups and data of all groups would be extracted when extracting continuous data. As to categorical data, we added up the sample size and event number of all groups, as recommended by the Cochrane handbook[6]. If there are any inconsistencies on the data extract between the two investigators, a third investigator reviewed the extracted results until a consensus was reached.

Quality assessment

The quality of the included RCTs was assessed using the Cochrane Risk of Bias Tool[6]. The risk of bias was accessed from the following 6 aspects: sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessors, incomplete outcome data, selective outcome reporting.

Data synthesis and statistical analysis

The analysis was performed using the statistical software open source R program (Version 3.41). The mean difference (MD = mean of bifocal IOL – mean of trifocal IOL) with) with a 95% confidence interval (95% CI) was adopted for continuous outcomes. If “0” falls into the confidence interval, the outcome would be considered statistically significant. Categorical outcomes were estimated by RR with 95% CI. If “1” falls into the confidence interval, the outcome would be considered statistically significant;

Heterogeneity across studies was tested with Q test and I2 statistic. The fixed-effect model (Mantel–Haenszel) was used if there was no heterogeneity across these RCTs(I2＜50% ). If the P-value was below 0.1 and I2 was above 50%, suggesting significant heterogeneity across these studies, the sensitivity analysis would be applied to examine whether the heterogeneity would decrease following exclusion of different studies. If not, a subgroup analysis would be performed or the DerSimonian and Laird random-effects model would be adopted to calculate pooled effect size[7, 8].

Result

Characteristics of included studies

Table 1 [see Additional file 1] describes the characteristics of the 8 included studies[9-16]. The median follow-up time was 18 months (Range: 3-24), and most subjects were over 60 years old. The included studies were published from 2014 to 2017.

Risk of bias assessment

There were 3 studies [11, 14, 15] describing the method for generating random sequence and 2 studies[11, 14] applying the blind method. Only Gundersen KG[12] described that the examiner was not masked to the lens type in his study. The details of risk assessment for each item of these RCTs were shown in the Figure 2 and Figure 3.

Near visual acuity

There were 5 studies reporting uncorrected near visual acuity (UNVA) and distant-corrected near visual acuity (DCNVA), and the I2 was 67% and 63% respectively. Sensitivity analyses were conducted, revealing the study published in 2014 by Mojzis P et al.[9] was the source of heterogeneity for the UNVA and DCNVA. After the study by Mojzis P et al. was excluded, the I2 were reduced to 0% for both UNVA and DCNVA. The difference of uncorrected near UNVA between the bifocal IOLs and trifocal IOLs had no clinical significance. The DCNVA of bifocal IOLs was similar to that of trifocal IOLs [MD=0.01, 95%CI: (-0.02,0.05), p=0.86 for DCNVA] (Figure 4 and Figure 6). No publication bias was found (Figure 5).

Intermediate visual acuity

There was a high heterogeneity effect size of uncorrected intermediate visual acuity (UIVA) and distance-corrected intermediate visual acuity (DCIVA), which was 79% and 89% respectively. Therefore, the random effects model was applied. As shown in Figure 7, the UIVA of bifocal IOLs had a significantly worse performance than trifocal IOLs with a MD of 0.09 [95%CI: (0.01,0.17), p＜0.01]. No publication bias was revealed (Figure 8). And there was also no difference in DCIVA [MD= 0.09, 95%CI: (-0.04, 0.23) , p＜0.01](Figure 9).

Since sensitivity analysis did not reveal the source of heterogeneity, the subgroup analysis was conducted. These RCTs were grouped by the type of IOLs. The UIVA and DCIVA of the bifocal IOLs for the AT LISA subgroup were significantly worse than those of trifocal IOLs [MD= 0.18, 95%CI: (0.12, 0.24), p=0.35 for UIVA and MD= 0.19, 95%CI: (0.13, 0.25), p=0.21 for DCIVA]. Furthermore, as Figure 8 and Figure 9 showed, the I2 reduced to 5% and 36% respectively

As shown in Figure 10, there were 2 RCTs reporting the outcomes of corrected intermediate visual acuity (CIVA). Although Mojzis P’s study published in 2014[9] found statistical differences between bifocal and trifocal IOLs. No difference between bifocal and trifocal IOLs [MD=0.04, 95% CI: (0.00, 0.09), p=0.67]. No publication bias was revealed, and Table 2 showed the Egger’s test outcome for each index.

Distant visual acuity

In terms of uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), there was no statistical heterogeneity among these RCTs (I2 = 0%). We found no statistically significant difference between the two groups, and the distant VA results were also similar [MD=0.01, 95%CI: (-0.01,0.04), p=0.51 for UDVA; MD=0.00, 95%CI: (-0.01,0.01), p=0.94 for CDVA] (Figure11 and 12).

Contrast sensitivity

Contrast sensitivity (CS) was reported in 6 studies. These studies indicated the highest CS was in 6 Cycles per Degree. Only Jonker 's study found the mean mesopic CS was higher in the bifocal groups, while the rest studies suggested no differences between these two groups. And Mojzis P’s study published in 2014 and 2017[9, 14] indicated the CS of trifocal groups was higher than that of bifocals under 3 Cycles per Degree.

Spectacle independence

Only two studies reported data on spectacle independence as shown in Figure 13. The spectacle independence of trifocal group was similar to the bifocal group, with the RR of 0.89 [95% CI: (0.71, 1.12), p=0.69].

Postoperative refraction

We did not find statistically significant difference in the postoperative refraction between the trifocal and bifocal groups [MD=-0.08, 95% CI: (-0.19, 0.03), p=0.51 for spherical equivalent; MD=-0.09, 95%CI: (-0.21, 0.03), p=0.78 for cylinder; MD=-0.09, 95% CI: (-0.27, 0.08), p=0.28 for sphere]. I2 of these indexes were 0% and 21% respectively (Figure 14, 15 and 16).

Posterior capsular opacification (PCO)

As shown in Figure 17, the PCO incidence in the bifocal group was similar to that in trifocal group, with RR of 1.81, [95% CI: (0.74, 1.15), p=0.65]. Although there were only two studies reporting the data on PCO, the outcomes of these two studies (I2=0%) showed great consistency (Figure 17).

Surgical satisfaction

Similar results were recorded by three studies[11, 15, 16], all of which suggested high satisfaction of patients after the surgery no matter in bifocal group or trifocal group. These studies showed great consistency (I2 = 0%). We also find no difference for surgical satisfaction between bifocal and trifocal groups [RR=0, 98, 95% CI: (0.86, 1.12), p=0.97] (Figure 18).

Admittedly, the level of evidence of RCT study is the highest according to the categories and recommendations of medical studies in the field of Evidence-based medicine (EBM)[17]. This study is the systematic review only on RCTs aiming to compare the visual performance of bifocal and trifocal IOLs. As the results showed, we found there was a statistically significant difference between the two groups in intermediated visual acuity. However, no statistical significance was found in other variables in our study except UIVA.

As the sensitivity analyses indicated, the study of Mojzis P et al was the source of heterogeneity of UNVA and DCNVA. The possible explanation might be that the follow-up interval of this study was 3 months while the interval of other studies was 6 mouths. In this study, no statistically significant difference between the two types of IOLs was found for UNVA and DCNVA. There are two possible reasons: despite the inconsistent outcomes of these RCTs, most of them reported no statistical difference of both lenses on the near vision improvement; multifocal IOLs designs were initially bifocal and were used to improve the postoperative vision acuity and reduce spectacle dependence at near distance. In fact, with the evolution of multifocal IOLs, both bifocal and trifocal IOLs showed excellent near visual performance[18, 19].

The intermediate vision greatly affects our daily work, exercise and social life, especially the computer uses in daily office work. Hence, it is also an important factor for the postoperative satisfaction of cataract patients[20, 21]. Our study revealed a better intermediate vision in the trifocal IOL implantation group. Tracing back to the development history of the multifocal IOLs, the trifocal IOLs was originally devised to overcome the limitation regarding the postoperative intermediate visual function. Since the outcomes of UIVA and DCIVA might be inconvincible due to the heterogeneity (I2＞79%), a subgroup analysis on different types of the bifocal IOLs and follow-up lengths was conducted. The heterogeneity of these RCTs can be eliminated by the bifocal IOLs types, but not follow-up time length. For the AT LISA subgroup, UIVA and DCIVA were significantly better in the trifocal IOLs (AT LISA tri 839M). Many researches have confirmed better intermediate visual performance of AT LISA tri 839M trifocal IOLs than the AT LISA bifocal IOLS in both clinical study and the optical bench[22-25], which prove that the AT LISA tri 839M can provide a third effective focus. Additionally, no difference was found for the UIVA and DCIVA between the bifocal (Re STOR bifocal IOLs) and the trifocal IOLs (Fine Vision trifocal IOLs) in another subgroup. Plaza-Puche AB[26] and Ruiz-Alcocer J [27] have demonstrated that the AT LISA tri IOLs supports better intermediate visual outcome than Fine Vision trifocal IOLs in the clinical experiment and optic blench respectively. Furthermore, Plaza-Puche AB corroborated that there was no difference in intermediate vision between the Fine Vision IOLs and the AcrySof ReSTOR bifocal IOLs, which is consistent with the results of RCTs included in this meta-analysis[11, 15]. Consequently, the difference between these two IOLs was no statistically significant.

Due to lack of measurement data, there were no conclusive results for contrast sensitivity. In this systematic review, studies that reported the CS suggested no difference of CS was found between bifocal and trifocal IOLs, and it is in accordance with previous researches[26, 28]. As many studies proved, there usually was significant difference of CS between the monofocal and multifocal IOLs[29-31]. Therefore, the addition of a third focal point does not seem to decrease of the postoperative optical quality.

Spectacle independence is one of the main factors for postoperative satisfaction and life quality of cataract patients, thus it is a commonly used item for the evaluation of the satisfaction，and life quality of cataract patients in several scales Like the National Eye Institute Refractive Error Correction Quality of Life Instrument-42 (NEI-RQL 42) questionnaire[32], Visual Function Index-14 (VF-14)[33] and other scales. In our study, the spectacle independence and postoperative satisfaction did not differ between the two IOLs. The lack of statistically significant difference may attribute to the fact that both IOLs showed excellence performance of spectacle independence, and this is in line with the results of previous studies[34-36]. In addition, the version of questionnaire used for spectacle independent and satisfaction in each single study was different. Therefore, the pooled effect might not be able to reveal the real effect of these two indices.

As for the findings related to postoperative refraction, we did not find any statistically significant difference between the two groups. Apart from the intermediate vision, the visual outcomes of both IOLs were excellent and similar. Many researches have proved that both bifocal IOLs and trifocal IOLs showed great clinical performance in terms of the refractive correction after surgery[37, 38]. Besides the postoperative refraction, there was also no difference of the PCO incidence between bifocal and trifocal groups.

Admittedly, there were some limitations in this study. First, this meta-analysis was not the first reviews to compare the visual performance of patients with bifocal and trifocal IOLs implementation. There were four similar systematic reviews focuses on the comparison of visual performance between patients implement bifocal and trifocal IOLs[39-42]. Even though this systematic review was the only one merely included RCTs. While as same with other four reviews, there was no more clinical finding in this study except for the intermediated vision. Second, we had to eliminate the no randomized controlled studies to ensure the quality of evidence, ended up with eight to compare. Furthermore, the total number of patients still comparable small for each type of IOL in the included studies. Consequently, we might can’t find significant differences of postoperative optical quality and refraction due to few studies and small samples. Second, the type of bifocal and trifocal IOLs was various, the pooled effect might not be as accurate as possible.

In conclusion, trifocal IOLs provide a better intermediate VA compared with bifocal IOLs, especially for the AT LISA subgroup. The near and distance visual performance, spectacle independence, contrast sensitivity, postoperative refraction and surgical satisfaction of bifocal IOLs were similar to those of trifocal IOLs.

IOLs，intraocular lens；VA，visual acuity；UNVA，uncorrected near VA ；DCNVA，distant-corrected near VA；UIVA，uncorrected intermediate visual acuity；DCIVA ，distance-corrected intermediate VA；UDVA，uncorrected distance VA；CDVA，corrected distance visual acuity；PCO，Posterior capsular opacification；CS，contrast sensitivity；NEI-RQL -42，National Eye Institute Refractive Error Correction Quality of Life Instrument-42 questionnaire；VF-14，Visual Function Index-14；

Competing interests

No authors have a financial and proprietary interest in any material and method mentioned. The authors declare that they have no competing interests.

Funding

Not applicable

Authors’ contributions

Study design and concept (Wan XH, Zhang JS, Wang JD,); database search (Jin SS, Cao K, Hou SM, Zhu GY), data extraction (Cao K), data analysis (Jin SS), manuscript writing (Jin SS, Wan XH), English polishing (Yusufu, M).

Acknowledgements

We thank Prof David S. Friedman for giving help in the writing of the manuscript.

Availability of data and materials

Not applicable

Ethics approval and consent to participate

Not applicable

Consent to publish

Not applicable

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Table 1. Characteristics of the included RCT studies (n = 8).

study	year	site	designs	bifocal	trifocal	follow up(mouth)
				age	N	IOL types	age	N	IOL types
Gundersen KG	2016	Norway	RCT	70.2±7.8	11	ReSTOR SND1T(Toric)	62.1±7.5	11	FineVision Toric	3
Jonker SM	2015	The Netherlands	RCT	64.0±8.8	13	ReSTOR+ 3.0D (SN6AD1)	62.6±8.8	15	Finevision Micro F	6
Alio JL	2017	New Zealand	RCT	63.2±7.7	17/15	AT LISA 809 M/ReSTOR (SN6AD1)	63.2±7.7	17	AT LISA tri 839MP	6
Bilbao-Calabuig R	2016	Spain	RCT	56.3±6.9	11	ReSTOR (SN6AD2/SN6AD1)	56.3±6.9	12	FineVision	3
Cochener B	2016	France	RCT	60.6±9.1	12	Tecnis ZMB00	58.7±6.4	15	FineVision Micro F	6
Mojzis P	2014	Czech	RCT	62.3±5.7	15	AT LISA 801	55.2±7.0	15	AT LISA tri 839MP	3
Mojzis P	2017	Czech	RCT	NR	18	AT LISA 801	NR	20	AT LISA tri 839MP	12
Gundersen KG	2016	Norway	RCT	53±8	30	ReSTOR (SN6AD1/ SN6AD2)	65±9	25	AT LISA tri839MP	24

Note: N=The number of people received the cataract surgery.

NR= Not report.

Table 2. Egger’s test for each outcome

Indicators	t	df	p
UNVA	0.877	4	0.430
DCNVA	0.741	3	0.513
UIVA	0.814	4	0.461
DCIVA	0.543	3	0.625
UDVA	-1.079	3	0.360
CDVA	0.101	5	0.923
Spherical equivalent refraction	-0.403	4	0.707
Refractive cylinder	-0.073	3	0.946
Residual sphere	0.316	1	0.805
Patients satisfaction	-0.177	1	0.888

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published 14 Mar, 2019

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Editorial decision: Revise
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16 Jan, 2019
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16 Jan, 2019
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16 Jan, 2019
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Comparison of Postoperative Visual Performance Between Bifocal and Trifocal Intraocular Lens Based on Randomized Controlled Trails: A Meta-Analysis

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