Comparative Visual Performance of Ultraviolet Light-Filtering and Violet Light-Filtering Monofocal Intraocular Lenses of the Same Material and Basic Design

doi:10.21203/rs.3.rs-3626556/v1

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Comparative Visual Performance of Ultraviolet Light-Filtering and Violet Light-Filtering Monofocal Intraocular Lenses of the Same Material and Basic Design

https://doi.org/10.21203/rs.3.rs-3626556/v1

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We compared the visual performance of ultraviolet light-filtering (ZCB00, Johnson & Johnson Surgical Vision) and violet light-filtering (ZCB00V, same manufacturer) monofocal intraocular lenses (IOLs) of the same material and basic design 10 weeks after the last surgery for implantation with bilateral lenses implanted ≤ 3 months apart in cataract patients treated between 2011 and 2020. The ZCB00 and ZCB00V groups comprised 904 eyes of 452 patients (72.3 ± 6.8 years; females/males, 268/184) and 1374 eyes of 687 patients (73.0 ± 7.4 years; female/male, 415/272), respectively. A linear mixed-effects model using the binocular data, with strict adjustments for sex, age, subjective refraction spherical equivalent, subjective refraction cylinder, corneal astigmatism, axial length, corneal higher-order aberrations, and pupil diameter, ensured statistical validity. Uncorrected intermediate/near visual acuity, corrected near visual acuity, and certain 25-item Visual Function Questionnaire (VFQ-25) components (Role_Limitation, Mental_Health, Social_Function, Distance_Vision, Color_Vision) were slightly but significantly better in ZCB00 recipients (p < 0.05, Wald). In contrast, ZCB00V recipients had significantly better contrast sensitivity with glare (visual angle of target: 6.3°/4.0°/0.7°; p < 0.00068, Wald), slightly but significantly better contrast sensitivity without (4.0°/2.5°/1.6°) and with glare (2.5°/1.6°/1.0°), VFQ-25 General_Health scores, and near spectacle independence, and slightly but significantly smaller higher-order aberrations (internal, scaled to a 6-mm pupil; Wavefront_6_post_I_Trefoil) (p < 0.05, Wald).

Health sciences/Diseases

Health sciences/Diseases/Eye diseases

Health sciences/Diseases/Eye diseases/Lens diseases

There has been a longstanding debate on the effects of tinted intraocular lenses (IOLs) since yellow-tinted IOLs were introduced to reduce cyanosis and provide protection against short-wavelength light, which could be toxic to the retina and retinal pigment epithelium^1–3. In contrast, the theoretical disadvantages of implanting blue-filtering tinted IOLs have also been considered, such as altered color perception, reduced color vision, a reduction in scotopic visual function, reduced contrast sensitivity in mesopic and scotopic conditions, and disruption of circadian photoentrainment^4–6. Although many studies have demonstrated that there are no significant differences among differentially tinted IOLs¹, it is still worth investigating the potential effects of IOL tinting through a study with a strictly controlled comprehensive analysis. The ZCB00 IOL (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) is an ultraviolet light-filtering IOL that has an aspherical, modified prolate anterior surface designed to minimize spherical aberrations and improve contrast sensitivity under mesopic conditions after cataract surgery^7–9. Based on this IOL, a violet light-filtering monofocal IOL (ZCB00V) (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) was developed; this blue-light transmitting, yellow-tinted lens preserves circadian rhythm and scotopic vision^4–6. Except for the tinting of the ZCB00V, both IOLs have the same material and basic design, consisting of acrylic optics measuring 6.0 mm in diameter. To our knowledge, no studies have undertaken a detailed, comprehensive clinical comparison of these two IOLs on a large scale under a strictly controlled analysis. Previously, we retrospectively compared the visual performance of several other combinations of the two IOLs based on a large set of patient data; in those studies, detailed statistical analysis with a linear mixed-effects model using data for both eyes, with strict adjustments for sex, age, subjective refraction spherical equivalent, subjective refraction cylinder, corneal astigmatism, axial length, corneal higher-order aberrations, and pupil diameter, successfully unveiled the different characteristics of the different lenses^10–12. In this study, using the same rigorous statistical analysis as in our previous report^10–12, we comprehensively compared the clinical performance of the ZCB00 group and the ZCB00V group in a large cohort of patients who underwent cataract surgery over a decade of clinical practice at a single hospital to clarify which product might be preferable for a patient undergoing cataract surgery and to investigate the potential effects of blue-light transmitting, violet light-filtering IOL yellow tinting on comprehensive visual performance.

Patient Characteristics

The patient demographic variables and pre and postoperative visual parameters used in the study are presented in Supplementary Table S1. The study included 2278 eyes of 1139 patients: 904 eyes of 452 patients in the ZCB00 IOL group (mean age: 72.3 ± 6.8 years; females/males, 268 [59.3%]/184 [40.7%]) and 1374 eyes of 687 patients in the ZCB00V IOL group (73.0 ± 7.4 years; female/male, 415 [60.4%]/272 [39.6%]).

Comparison of Postoperative Parameters between the Ultraviolet Light-Filtering Monofocal IOL (TECNIS ZCB00) and the Violet Light-Filtering Monofocal IOL (TECNIS ZCB00V)

Multiple regression analysis was conducted on all postoperative parameters of the two groups 10 weeks after surgery in both eyes in the same way as in our previous studies^10–12, i.e., we ensured statistical validity through a linear mixed-effects model using data for both eyes, with strict adjustments for sex, age, subjective refraction spherical equivalent, subjective refraction cylinder, corneal astigmatism, axial length, corneal higher-order aberrations, and pupil diameter. The parameters were adjusted by multiple regression according to the explanatory variables in Table 1. The results of the analysis are shown in Supplementary Table S2.

Table 1

Parameters of the ultraviolet light-filtering monofocal IOL (ZCB00) and violet light-filtering monofocal IOL (ZCB00V) groups that were used to adjust the linear regression model: age, sex, axial length (at the time of surgery), subjective refraction spherical equivalent (SE), subjective refraction cylinder (CYL), corneal astigmatism (keratometric cylinder), corneal higher-order aberrations (astigmatism, total higher-order aberration (HOA), third, fourth, trefoil, coma, tetrafoil, second-order astigmatism (2ndAstig), spherical refraction (scaled to a pupil size of 4 mm/6 mm), and pupil diameter (at 10 weeks after surgery)).
(A) Categorical variables
		N (%)
Variable	Levels	ZCB00	ZCB00V	p value
Sex	F/M	268 (59.3)/184 (40.7)	415 (60.4)/272 (39.6)	7.534E-01
(B) Continuous variables
		N, Mean ± SD
Variable		ZCB00	ZCB00V	p value
Age		452, 72.301 ± 6.817	687, 72.987 ± 7.389	5.226E-03*
SE		762, 0.110 ± 0.474	1293, 0.075 ± 0.451	1.849E-01
CYL		640, -0.955 ± 0.535	1293, -0.596 ± 0.538	3.094E-42**
Corneal astigmatism		754, -0.780 ± 0.461	1242, -0.720 ± 0.421	7.415E-03*
Axial length		900, 23.536 ± 1.283	1373, 23.661 ± 1.376	2.717E-02*
WF_4_post_C
Astigmatism		581, -0.998 ± 0.631	937, -0.888 ± 0.566	1.530E-03**
Total HOA		581, 0.233 ± 0.127	937, 0.232 ± 0.131	5.957E-01
Third		581, 0.201 ± 0.123	937, 0.198 ± 0.116	6.210E-01
Fourth		581, 0.107 ± 0.059	937, 0.111 ± 0.079	7.689E-01
Trefoil		581, 0.155 ± 0.102	937, 0.150 ± 0.101	3.447E-01
Coma		581, 0.112 ± 0.092	937, 0.112 ± 0.085	8.253E-01
Tetrafoil		581, 0.069 ± 0.047	937, 0.068 ± 0.053	2.274E-01
2nd Astig		581, 0.047 ± 0.042	937, 0.048 ± 0.040	2.399E-01
Spherical		581, 0.045 ± 0.045	937, 0.039 ± 0.074	2.665E-01
WF_6_post_C
Astigmatism		500, -0.740 ± 1.021	834, -0.642 ± 0.561	5.431E-04**
Total HOA		500, 0.704 ± 1.285	834, 0.663 ± 0.789	7.936E-03*
Third		500, 0.474 ± 0.894	834, 0.454 ± 0.487	7.945E-01
Fourth		500, 0.440 ± 0.719	834, 0.405 ± 0.435	2.073E-07**
Trefoil		500, 0.348 ± 0.636	834, 0.334 ± 0.376	5.348E-01
Coma		500, 0.288 ± 0.646	834, 0.273 ± 0.341	8.647E-01
Tetrafoil		500, 0.212 ± 0.466	834, 0.191 ± 0.287	3.069E-03*
2nd Astig		500, 0.134 ± 0.457	834, 0.124 ± 0.279	9.650E-01
Spherical		500, 0.321 ± 0.345	834, 0.287 ± 0.243	1.149E-05**
Pupil diameter, post		592, 4.190 ± 0.811	980, 4.325 ± 0.817	7.514E-04**
For categorical data, counts and frequencies are shown. Fisher’s exact test (two-sided) was used to compare categorical data for the ultraviolet light-filtering monofocal and violet light-filtering monofocal IOL groups. For numerical data, the mean and standard deviation are shown, and the two-sided Mann‒Whitney U test was used for comparisons between the two IOL groups.
SE: subjective refraction spherical equivalent; CYL: subjective refraction cylinder; WF_4_post_C_: wavefront_4_post_corneal; HOA: higher-order aberration.
p < 0.05, *p < 0.002 (= 0.05/25).

In the ZCB00 group, uncorrected intermediate/near visual acuity, corrected near visual acuity, and scores on the components of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) (Role_Limitation, Mental_Health, Social_Function, Distance_Vision, Color_Vision) were slightly but significantly better, and higher-order aberrations (internal, scaled to a 6-mm pupil; Wavefront [WF]_6_post_I_Trefoil) were slightly but significantly smaller than in the ZCB00V group (p < 0.05, Wald test) (Table 2 and Figs. 1 and 2). In the ZCB00V group, contrast sensitivity measured with glare (visual angle of the test target: 6.3°/4.0°/0.7°) was significantly better (p < 0.00068, Wald test), and contrast sensitivity measured without (4.0°/2.5°/1.6°) or with glare (2.5°/1.6°/1.0°), VFQ-25 General_Health scores, and near spectacle independence were slightly but significantly better than in the ZCB00 group (p < 0.05, Wald test) (Table 2 and Figs. 1–3).

Table 2

Parameters demonstrating significant differences between the ultraviolet light-filtering monofocal IOL (ZCB00) and violet light-filtering monofocal IOL (ZCB00V) groups 10 weeks after surgery in both eyes.
	Sample size, value after adjustment
Response, postoperative	ZCB00	ZCB00V	Coefficient (95% CI)	p value (Wald test)
UIVA	232, 0.31 ± 0.13	1197, 0.37 ± 0.14	0.05(0.02, 0.09)	4.963E-03*
UNVA	826, 0.54 ± 0.16	1223, 0.57 ± 0.16	0.03(0.01, 0.06)	1.390E-02*
CNVA	827, 0.02 ± 0.04	1223, 0.03 ± 0.06	0.01(0.00, 0.02)	8.103E-03*
WF_6_post_I
Tetrafoil	500, 0.47 ± 0.59	834, 0.47 ± 0.42	0.07(0.00, 0.13)	3.718E-02*
Contrast sensitivity
C_4.0_post	844, 0.03 ± 0.01	1230, 0.03 ± 0.01	-0.00(-0.01, -0.00)	2.673E-03*
C_2.5_post	844, 0.04 ± 0.01	1230, 0.04 ± 0.01	-0.00(-0.01, -0.00)	1.419E-02*
C_1.0_post	844, 0.03 ± 0.01	1229, 0.03 ± 0.01	-0.00(-0.01, -0.00)	2.673E-03*
Contrast sensitivity with glare
G_6.3_post	843, 0.04 ± 0.02	1230, 0.04 ± 0.02	-0.01(-0.01, -0.00)	6.389E-04**
G_4.0_post	843, 0.05 ± 0.02	1230, 0.04 ± 0.02	-0.01(-0.01, -0.01)	1.109E-05**
G_2.5_post	843, 0.07 ± 0.04	1230, 0.06 ± 0.03	-0.01(-0.02, -0.00)	9.905E-03*
G_1.6_post	843, 0.10 ± 0.05	1229, 0.09 ± 0.05	-0.01(-0.02, -0.00)	3.690E-03*
G_1.0_post	843, 0.18 ± 0.08	1229, 0.16 ± 0.08	-0.02(-0.03, -0.01)	1.942E-03*
G_0.7_post	842, 0.33 ± 0.08	1227, 0.30 ± 0.08	-0.03(-0.04, -0.01)	1.168E-04**
VFQ-25
General_Health	356, 59.35 ± 3.34	533, 60.75 ± 3.61	1.88(0.30, 3.47)	1.969E-02*
Role_Limitation	356, 95.36 ± 1.74	533, 94.06 ± 1.89	-1.30(-2.44, -0.15)	2.650E-02*
Mental_Health	356, 94.49 ± 1.91	533, 92.56 ± 2.07	-1.96(-3.19, -0.74)	1.718E-03*
Social_Function	356, 95.77 ± 1.13	533, 95.21 ± 1.25	-0.92(-1.73, -0.11)	2.565E-02*
Distance_Vision	356, 93.55 ± 1.42	533, 92.88 ± 1.53	-1.01(-1.95, -0.07)	3.460E-02*
Color_Vision	351, 159/192	530, 454/76	-0.50(-0.81, -0.19)	1.614E-03*
Spectacle dependence
Near	344, 0/5/339	524, 1/6/517	-0.26(-0.48, -0.05)	1.650E-02*
Each parameter was adjusted by multiple regression with the explanatory variables in Table 1. For each response variable, the mean and standard deviation for each numerical parameter or the counts for each categorical parameter (spectacle dependence: never/sometimes/always), the regression coefficient, its 95% confidence interval, and the p value (Wald test) are shown.
UIVA: uncorrected intermediate visual acuity; UNVA: uncorrected near visual acuity; CNVA: corrected near visual acuity; WF_6_post_I_: wavefront_6_post_internal; WF_4_post_I_: wavefront_4_post_internal; C: contrast sensitivity; G: contrast sensitivity with glare.
* p < 0.05, **p < 0.00068.

In this study, we conducted a comprehensive clinical comparison of the visual performance of the ultraviolet light-filtering monofocal IOL (TECNIS ZCB00 IOL) and the violet light-filtering monofocal IOL (TECNIS ZCB00V IOL), both of which are of the same material and basic design, in a large sample from a single eye institute in a detailed statistical analysis. Although high contrast sensitivity was maintained at all angles with and without glare in both groups, contrast sensitivity measured with glare (visual angle of the test target: 6.3°/4.0°/0.7°) was significantly better in the ZCB00V group than in the ZCB00 group (p < 0.00068, Wald test) (Table 2 and Figs. 1 and 3). Likewise, contrast sensitivity measured without (4.0°/2.5°/1.6°) or with glare (2.5°/1.6°/1.0°) was slightly but significantly better in the ZCB00V group (p < 0.05, Wald test) (Table 2 and Figs. 1 and 3). We measured contrast sensitivity using the CGT-1000 instrument, which can automatically measure contrast sensitivity¹³ at six target sizes (visual angle of the test target: 6.3°/4.0°/2.5°/1.6°/1.0°/0.7°) and 13 contrast levels (0.01 to 0.64 contrast or 2.00 to 0.34 log₁₀CS) with or without glare. We previously reported that the contrast sensitivity measured with the CGT-1000 was better with the monofocal ZCB00 IOL than with the corresponding multifocal lens (the ZMB00 IOL) at most frequencies, both with and without glare¹⁰. The TECNIS IOL aspherical design inherited by both IOLs was developed to improve contrast sensitivity by reducing or canceling the normal positive spherical aberration of the cornea; the performance of IOLs with this design has relatively little dependence on pupil size. Compared to spherical IOLs, aspherical IOLs reportedly show decreased wavefront spherical aberrations and improved contrast sensitivity^7,14–18. Thus, users of the ZMB00 IOL in that study, despite the deterioration of contrast sensitivity with the use of diffractive multifocal IOLs, still had better contrast sensitivity both with and without glare than the normal 60-year-old Japanese subjects assessed by Takahashi^10,19,20. The superiority of the contrast sensitivity of the ZCB00V, the violet light-filtering monofocal IOL, over that of the ZCB00, the ultraviolet light-filtering monofocal IOL, in the present study can be explained by the possible beneficial effect of one of the key characteristics of the lens, its violet light-filtering functions. It has been reported that yellow tint helps reduce the scattered light that adversely affects contrast sensitivity²¹, and our study results corroborate this theory.

Regarding visual acuity, although the difference was slight, the ZCB00 IOL group had significantly better uncorrected intermediate/near visual acuity (UIVA/UNVA) and corrected near visual acuity (CNVA) than the ZCB00V IOL group (p < 0.05, Wald test) (Table 2 and Fig. 1). Jang et al.²² reported the negative effect of yellow-tinted IOLs on short-wavelength automated perimetry results. It is possible that blocking a wider range of short-wavelength lights, including violet light in the ZCB00V, might partially worsen the outcome of visual acuity testing, although it is a very tiny effect. On the other hand, approximately 10.8% of patients in the ZCB00 group and 10.1% of patients in the ZCB00V group were fully spectacle independent, with no significant difference between the two groups in the present study (odds ratio = 0.93 (95% CI 0.60, 1.45), p value = 0.820). Moreover, near spectacle independence was slightly but significantly better in the ZCB00V group (p < 0.05, Wald test), which could be partly due to higher contrast sensitivity. As a whole, there were no large differences regarding visual acuity-related items between the two lenses, as shown in previous reports comparing differentially tinted IOLs¹.

One particular higher-order aberration variable (internal, scaled to a 6-mm pupil; WF_6_post_I_Trefoil) was slightly but significantly better in the ZCB00 group than in the ZCB00V group (p < 0.05, Wald test) (Table 2 and Fig. 1); otherwise, there were not even small differences in most of the higher-order aberration variables (astigmatism, total higher-order aberration (HOA), third, fourth, trefoil, coma, tetrafoil, second-order astigmatism (2ndAstig), spherical (ocular/internal, scaled to a pupil size of 4 mm/6 mm) between the two groups.

The NEI VFQ-25 is a self-report questionnaire used to measure vision-related health status^23,24. This questionnaire can be used to evaluate changes in subjective visual function following cataract surgery, and it has been translated into several languages, including Japanese; the Japanese version was validated by Suzukamo et al.²⁵. In our study, the VFQ-25 scores for Role_Limitation, Mental_Health, Social_Function, Distance_Vision, and Color_Vision were slightly but significantly better in the ZCB00 group (p < 0.05, Wald test) (Table 2 and Figs. 1 and 2). On the other hand, the VFQ-25 score for General_Health was slightly but significantly better in the ZCB00V group (p < 0.05, Wald test) (Table 2 and Figs. 1 and 2). The superior VFQ score of Color_Vision in the ZCB00 group could be simply understood to mean that a lack of violet-color filtering helps patients to distinguish colors more clearly; in other words, there could be some negative effects of the violet light-filtering yellow-tinted material of the ZCB00V on color perception in human beings, even though that effect would be minor.

Although the ZCB00V IOL preserves blue light transmission, which is necessary for circadian rhythm and scotopic vision, reduces cyanosis after cataract surgery, and filters the scattered light that adversely affects contrast sensitivity, it is also possible that blocking violet light could affect human physiology. The ultraviolet component of sunlight is known to be utilized in a variety of animal species for environmental cues, e.g., for flower discrimination and orientation/navigation in insects^26,27 and for mate choice and parent–offspring communication in birds^28,29. Concordantly, these animals have ultraviolet light-sensitive photoreceptors in their eyes³⁰. The Commission Internationale de l’Eclairage (CIE) has established the lower limits of the wavelengths of visible light to be between 360 and 400 nm³¹, which coincides with the upper end of the ultraviolet A spectrum³². While this range is visible as violet light, it is also identified as ultraviolet. Kojima et al.³³ revealed that the human retina contains neuropsin (Opsin 5 [Opn5], encoded by the Opn5 gene), whose maximum absorption wavelength is at 380 nm; this protein may play some important roles in human physiology. However, they concluded that it would be unlikely to be activated effectively based on the results of their quantitative PCR analysis of human OPN5 mRNA showing no significant expression in the retina. On the other hand, Torii et al.^34,35 confirmed that violet light (VL, 360–400 nm wavelength) suppressed axial length elongation by upregulating the myopia-suppressive gene EGR1, suggesting a critical role of violet light in human eyeball development. Opn5-expressing retinal cells, specifically retinal ganglion cells, play a critical role in the refractive development pathway, as demonstrated by Jiang et al.³⁶ Furthermore, Jeong et al.³⁷ found that violet light exposure led to increased expression of both EGR-1 mRNA and protein in the mouse retina and retinal cells (661W), indicating a complex interaction between Opn5 and EGR-1 in the retina under violet-light stimulation. Thus, although the beneficial effects of blocking short-wavelength light are widely accepted in the current scientific understanding¹, there might be some still unknown biological differences in the eyes after cataract surgery implanting ultraviolet or violet light-filtering IOLs.

There are some potential limitations in this study. One is that we only measured intermediate visual acuity at a distance of 50 cm and near visual acuity at a distance of 30 cm. In the context of Japanese patients, maintaining optimal visual acuity at these close distances is crucial for performing tasks that require working within arm's length and reading with precision. As this study compared two different monofocal IOLs, data such as the defocus curves of the two IOLs were not the main evaluation items. Ideally, however, to thoroughly assess the performance of lenses, it were desirable to conduct visual acuity tests at varying distances. There is a contentious debate among experts regarding the optimal distance for measuring intermediate visual acuity, with viewpoints ranging between 50 cm and 100 cm³⁸. Typically, handheld devices and computers require users to rely on intermediate vision³⁹, which is usually assessed within arm's reach by having patients hold a test chart. Notably, the ideal distance for measuring intermediate vision can vary depending on the patient's physical characteristics. For instance, Japanese patients may need to be assessed at a closer distance than American or European patients due to differences in average body size and arm length between the populations. Hence, we assessed visual acuity at an intermediate distance of 50 cm, which was deemed feasible for the majority of Japanese patients participating in this research.

Second, the study's retrospective design creates a potential limitation in that patients in the two groups may have had different social backgrounds. However, this study was conducted at a single center on a large scale, and it was carried out in a consistent manner. The study protocol involved obtaining written informed consent from all participants before surgery, and the same battery of pre- and postoperative examinations, including the VFQ-25, which gathers data on the social background of the patients, were performed. We evaluated parameters 10 weeks after the last surgery in cataract patients who underwent bilateral ZCB00 or ZCB00V implantation, with the right and left lenses implanted within 3 months of each other; furthermore, the data were meticulously analyzed, with strict adjustment for various factors such as age, sex, axial length, subjective refraction SE, subjective refraction CYL, corneal astigmatism (keratometric cylinder), corneal higher-order aberrations, and pupil diameter to ensure the accuracy of the results. The dataset comprises items that were assessed for both eyes simultaneously as well as items evaluated separately for each eye. To ensure the accuracy of our analysis, we employed a linear mixed-effects model and corrected for multiple observations of each eye per case, further enhancing the precision and reliability of our results. Despite being a retrospective study, the sampling process for patients receiving lenses was both random and independent, and all endpoints were accurately measured. In statistical analysis, the common belief is that random assignment does not introduce bias in the analysis results, even if the case numbers are not equal. A classic illustration of this principle is the 1:n allocation method employed in clinical trials.

Third, it is worth noting that the study was conducted solely at a Japanese facility, which means that the VFQ-25 outcomes may not be generalizable across different racial groups. To put it differently, the findings of a global patient study may not necessarily be applicable to a specific geographical area due to regional differences. In studies that include individuals of different races, it may be necessary to adjust for the regional diversity of the individuals to accurately evaluate differences in pure lens performance.

Fourth, the scientific justification for the study is not as strong as that of a randomized prospective study. However, the implementation of such a strategy would be deemed unethical and impractical, as the probability of substitution is substantially elevated. Research studies that involve significant sample sizes and in-depth clinical information, such as the one presented here, are widely acknowledged for their certain level of credibility. As such, we believe that these studies hold great value in terms of clinical applications and can provide important insights.

In conclusion, we compared the visual performance of an ultraviolet light-filtering monofocal IOL, ZCB00, and a violet light-filtering monofocal IOL, ZCB00V. Patients in the ZCB00 group had slightly but significantly better uncorrected intermediate/near visual acuity, corrected near visual acuity, and VFQ-25 scores (Role_Limitation, Mental_Health, Social_Function, Distance_Vision, Color_Vision) and slightly but significantly smaller higher-order aberrations (internal, scaled to a 6-mm pupil; WF_6_post_I_Trefoil), whereas patients in the ZCB00V group had better contrast sensitivity measured with glare (6.3°/4.0°/0.7°) and had slightly but significantly better contrast sensitivity without (4.0°/2.5°/1.6°) or with glare (2.5°/1.6°/1.0°), VFQ-25 General_Health scores, and near spectacle independence. At a superior level of performance, the two groups of IOLs exhibited distinctive attributes with respect to diverse vision-related parameters.

Design

Retrospective comparative case series

Setting

Department of Ophthalmology, Tsukazaki Hospital, Japan

Patients

We analyzed data from a consecutive series of cataract patients who underwent bilateral implantation of ultraviolet light-filtering monofocal IOLs (TECNIS ZCB00 [Johnson & Johnson Surgical Vision]) and violet light-filtering monofocal IOLs (TECNIS ZCB00V [Johnson & Johnson Surgical Vision]) between January 4, 2011, and November 19, 2020, with the right and left lenses implanted within an interval of 3 months, as in our previous study^10–12. Participants were recruited for enrollment in a consecutive case series study (outpatients with or without a doctor’s referral). There is no potential self-selection bias that might confound the results. The exclusion criteria were other ocular diseases that might affect visual function, |subjective equivalent (SE)| > 2.00 D, |subjective refraction cylinder (CYL)| > 3.00 D and |corneal astigmatism (keratometric cylinder)| > 3.00 D 10 weeks following surgery.

Preoperative Examination

Preoperative examinations were conducted as described in our previous study^10–12. All patients underwent full ophthalmologic examinations, including evaluations of the corneal curvature radius, corneal astigmatism, axial length, refractive status, ocular aberrations, pupil diameter, distance/intermediate/near visual acuity, contrast sensitivity, and contrast sensitivity under glare, as well as anterior segment evaluations using a slit lamp, tonometry and indirect fundoscopy. The quality of vision was evaluated using the Japanese version of the NEI VFQ-25²⁵, which was administered by experienced technicians or nurses in a face-to-face setting. Patients were also asked about their use of spectacles for distance, intermediate and near vision (the response options were “never,” “sometimes” and “always”).

Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were both measured at 5.0 m. Uncorrected intermediate visual acuity (UIVA) and corrected intermediate visual acuity (CIVA) were both measured at 0.5 m. Uncorrected near visual acuity (UNVA) and corrected near visual acuity (CNVA) were both measured at 0.3 m. Visual acuity was measured using the decimal visual acuity chart, with resulting decimal values converted to the logarithm of the minimum angle of resolution (logMAR) scale. The corneal curvature radius, corneal astigmatism, and objective refractive status were measured using a KR-8900 autorefractor keratometer (Topcon, Tokyo, Japan). Axial length was measured using IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and AL-3000 (TOMEY, Nagoya, Japan) biometers. Contrast sensitivity and contrast sensitivity under glare (visual angle of the test target: 6.3°/4.0°/2.5°/1.6°/1.0°/0.7°; 13 contrast levels: 0.01 to 0.64 contrast or 2.00 to 0.34 log10CS) were measured using a CGT-1000 contrast glare tester (Takagi Seiko, Nakano, Japan)^10–13,19, and the pupil diameter and ocular aberrations were measured using a KR-1W Wavefront Analyzer (Topcon, Tokyo, Japan). All measurements were taken by experienced technicians.

IOLs and Surgical Techniques

Patients chose which IOLs to have implanted after receiving information about the advantages and disadvantages associated with each type, as in our previous study^10–12. Patients in the ultraviolet light-filtering monofocal IOL group received the TECNIS ZCB00, while those in the violet light-filtering monofocal IOL group received the TECNIS ZCB00V bilaterally. The goal for all eyes was emmetropia for distance vision.

The TECNIS ZCB00 (Johnson & Johnson Surgical Vision, Santa Ana, CA, United States) is a single-piece, ultraviolet light-filtering monofocal hydrophobic acrylic lens with a posterior diffractive surface and aspheric anterior surface that adds − 0.27 µm of spherical aberration to the human eye. This aspherical, modified prolate anterior surface was designed to minimize spherical aberrations and improves postcataract-surgery contrast sensitivity under mesopic conditions. It has acrylic optics measuring 6.0 mm in diameter.

The TECNIS ZCB00V (Johnson & Johnson Surgical Vision, Santa Ana, CA, United States) is a single-piece, blue-light transmitting, violet light-filtering, yellow-tinted monofocal hydrophobic acrylic lens with a posterior diffractive surface and aspheric anterior surface that adds − 0.27 µm of spherical aberration to the human eye and has acrylic optics measuring 6.0 mm in diameter; the material and basic design are the same as those of the TECNIS ZCB00.

The cataract surgeries were performed by 21 experienced cataract surgeons using the same standard technique of sutureless microincision phacoemulsification and the same protocol. The surgical procedures consisted of topical anesthesia, the creation of a scleral or corneal incision of 1.8 to 2.8 mm, 5 mm of continuous capsulorhexis, cataract extraction by phacoemulsification, and IOL implantation with an injector.

Postoperative Examination

Patients were evaluated 10 weeks after surgery using the same examination protocol that was used preoperatively.

Statistical Analyses

The necessary sample size was calculated for an alpha of 0.00068 and a power of 0.80. A standard deviation in visual acuity (VA) of 0.10 logMAR units was presumed, in addition to a minimum detectable difference of 1 line of VA (0.1 logMAR), based on our previous study¹⁰; this calculation suggested a minimum necessary sample size of 39 eyes per group. The ZCB00 and ZCB00V groups comprised 904 eyes of 452 patients and 1374 eyes of 687 patients, respectively; thus, the sample size was sufficient.

As in our previous study^10–12, the two groups were compared in terms of the following postoperative parameters 10 weeks after surgery in both eyes: (1) mixed-effects linear regression: visual acuity (uncorrected/corrected, distance/intermediate/near), contrast sensitivity (with/without glare), and higher-order aberrations (ocular/internal, scaled to a pupil size of 4 mm/6 mm); (2) linear regression model or logistic regression: VFQ-25 score; and (3) cumulative logistic regression: spectacle dependence (distance/intermediate/near). In both groups, adjustments were made for age, sex, axial length, subjective refraction spherical equivalent, subjective refraction cylinder, corneal astigmatism, corneal higher-order aberrations and pupil diameter. In regression analyses (2) and (3), the data were divided into two parts (left-eye data and right-eye data), and the regression model was applied to each dataset. Since discrete scores were observed for "Peripheral_Vision", "Color_Vision", "Driving_Daytime", "Driving_Nighttime", and "Driving_Adverse_Conditions" on the VFQ-25, we treated them as binary data. We divided the patients into two groups (those with scores of 75 or lower and those with scores above 75) and applied the logistic regression model to both groups. The threshold was determined from the distributions of the following variables: Peripheral_Vision, Color_Vision, Driving_Daytime, Driving_Nighttime, and Driving_Adverse_Conditions. A threshold of 75 was used in this study because most VFQ-25 scores were > 75 after surgery. The results of the left- and right-eye analyses were combined using the inverse variance method; the corrected values were calculated for the left- and right-eye datasets, and the average values were used. In all multivariate analyses, the missing values of explanatory variables were filled in by the multiple imputation method with 10 imputations.

In the regression analysis, the Wald test (two-sided) was applied to evaluate the significance of differences in postoperative parameters between the two groups using a Bonferroni corrected significance level of 0.00068. Correlations between postoperative parameters were calculated for the ultraviolet light-filtering monofocal and violet-light-filtering monofocal groups, and a heatmap of Pearson correlation coefficients was generated for each group. In the correlation analysis, two-sided t tests were used to evaluate whether each coefficient significantly differed from zero, and the significance level was set at 0.00002 using the Bonferroni correction.

The statistical analyses were performed using a commercially available software program (R, version 3.6.1; R Core Team, 2019, Vienna, Austria)⁴⁰, and a multiple imputation analysis was implemented by using the "mice" package in R⁴¹.

Ethics Statement

This study conformed to the tenets of the Declaration of Helsinki and was approved by the Ethics Committee of Tsukazaki Hospital. All research was performed in accordance with relevant guidelines/regulations. Written informed consent was obtained from each subject. This study was registered as UMIN000035630: “Performance comparison among different intraocular lenses in cataract surgery”.

Code Availability

Not applicable.

Data Availability

All data relevant to the study are included in this article or have been uploaded as supplementary information.

Acknowledgments

We thank all of the staff members of Tsukazaki Hospital who were involved in this study. The statistical results and the validity of the study design were rigorously reviewed by a professional data analysis company in Japan (StaGen Co., Ltd.), and a certificate of the review of statistical methods by a professional statistician was issued. Research Square has also thoroughly confirmed the quality of this manuscript and has issued a validity report in the form of a Methods and Data Reporting Certification. The manuscript was edited for proper English language, grammar, punctuation, spelling, and overall style by one or more of the highly qualified native English-speaking editors at American Journal Experts (AJE), and a certificate was issued.

Author Contributions

H.T. (Hirotaka Tanabe), H.T. (Hitoshi Tabuchi), and T.Y. conceived the study; T.S. and K.T. conducted the examinations and collected the data; H.T. (Hirotaka Tanabe) analyzed the results; and H.T. (Hirotaka Tanabe) wrote the manuscript. All authors reviewed the manuscript.

Additional Information

Competing Interests

The authors declare that they have no competing interests.

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No competing interests reported.

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Comparative Visual Performance of Ultraviolet Light-Filtering and Violet Light-Filtering Monofocal Intraocular Lenses of the Same Material and Basic Design

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Abstract

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Introduction

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Patient Characteristics

Discussion

Methods

Design

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Patients

Preoperative Examination

IOLs and Surgical Techniques

Postoperative Examination

Statistical Analyses

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References

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