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Efficacy and comfort following the implantation of extended depth of focus, multifocal, and monofocal intraocular lenses in cataract patients

BMC Ophthalmology volume 24, Article number: 423 (2024) Cite this article

Abstract

Background

Extended depth of focus (EDOF) and multifocal (Multi) intraocular lenses (IOL) can provide a fixed distance of near vision, which may result in some discomfort for patients who prefer different near distances. The aim of this study was to compare the vision, comfortable near distance (CND) and visual comfort in patients who underwent implantation of EDOF, Multi, and monofocal (Mono) IOLs.

Methods

A total of 100 eyes were implanted with Tecnis ZXR00, ZMB00 or ZCB00 IOLs. Uncorrected distance, intermediate, and near visual acuity (UDVA, UIVA, and UNVA, respectively), corrected distance visual acuity (CDVA), the fluctuations of CND, the ability to see at comfortable or standard near distance and visual comfort were evaluated at 3-month postoperative.

Results

At 3 months postoperative, the EDOF and Multi groups showed non-inferiority compared to the Mono group in the UDVA (P > 0.05) and CDVA (P > 0.05) but superiority in the UNVA (P < 0.001). The UIVA was better in the EDOF group, with comparable results for the Multi and Mono groups. There was no difference in preoperative and postoperative CND in the three groups. The CND visual acuity (CNDVA) was lower than the UNVA in the three groups, especially in the EDOF and Multi groups (P < 0.05). The CND effectively improved patients’ near visual comfort and visual clarity, except for one patient in the Multi group who complained of severe fatigue and was unable to tolerate the experience at month 3.

Conclusion

The EDOF and Multi IOLs achieved excellent visual quality and superior UNVA compared to the Mono IOL, but the CNDVA was significantly inferior to the UNVA. Patients’ near visual experience can be effectively improved at their CND.

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Introduction

The pioneering implantation of the intraocular lens (IOL) by Harold Ridley in 1949 marked the beginning of a momentous change in the practice of ophthalmology [1]. With the refinement of cataract surgery, there has been a notable evolution in the field, with an emphasis on achieving a full range of vision and keeping visual comfort as the primary concern of development. Conventional monofocal IOLs have limitations in terms of their ability to provide patients with optimal near vision due to the lack of accommodation [2]. This result has promoted the development of multifocal intraocular lenses (MIOLs). The principles underlying MIOL technology are diffraction and refraction of light, adding specific diopters (D) to facilitate the convergence of light at numerous foci [3, 4]. The brain then identifies a clear point to provide visual clarity at a certain and usually fixed distance.

Although MIOLs have offered a wealth of options and greater opportunity for spectacle independence for patients beyond the monofocal IOL selections, the fixed refractive diopters limit the flexibility of MIOLs, restricting patients to a fixed range of near vision [5]. There will be a major challenge in the design of MIOLs for those patients who prefer different distances, such as the comfortable near distance (CND), to work. Visual comfort enhanced efficiency in close-range tasks [6]. The CND can be measured before surgery and directly impact IOL powers. However, most studies on MIOL implantation have focused on near vision at 33–40 cm, while visual outcomes at their CND has been reported in fewer studies [7]. Thus, the purpose of our study was to compare the vision, CND and visual comfort in patients undergoing cataract surgery with implantation of a monofocal, a multifocal and an EDOF IOL, which may provide new insights for the clinical application of MIOL.

Methods

Patients

This prospective study included 100 consecutive eyes who underwent cataract surgery at the Affiliated Hospital of Nantong University from October 2021 to March 2023. Besides, 15 eyes withdrew before the end of the study due to individual inconvenience. Inclusion criteria for participants were cataract at 35 years of age or older, and estimated postoperative corneal astigmatism ≤ 1.0 D, all of whom completed three months of follow-up. Exclusion criteria involved clinical corneal diseases, ocular inflammation, glaucoma, diabetic retinopathy, vision-limiting ocular comorbidities, such as amblyopia and macular disease, and previous ocular surgery. In addition, patients who had psychological disorders such as depression and anxiety were excluded. The study program was approved by the Ethics Committees of the Affiliated Hospital of Nantong University (approval ID: 2019-K068), and enrollment and written informed consent were performed according to the tenets of the Declaration of Helsinki.

Procedures

The preoperative assessment consisted in: biomicroscopy, fundoscopy, optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) at 5 m under photopic (85 Candelas [cd]/m2) lighting conditions, corneal astigmatism (Pentacam; Oculus, Inc.), axial length and IOL power (which was calculated using the Barrett Universal II formula, A constant value = 119.3) (Lenstar; LS900, Inc.).

The participants chose their preferred lens to be implanted into eyes after IOL adequacy was confirmed. If both eyes were treated, the eyes were then separately evaluated. Emmetropia was targeted in both the Multi and Mono groups of eyes, but the target refraction was − 1.0 D in both eyes for the EDOF group to improve near vision, out of prudence and after discussion with the patients. The follow-up visits were scheduled at 1 day, 1 week, 1 month and 3 months. Under photopic (85 Candelas [cd]/m2) lighting conditions, the postoperative visual outcomes including UDVA and CDVA at 5 m, uncorrected intermediate visual acuity (UIVA) at 80 cm, and uncorrected near visual acuity (UNVA) at 40 cm were measured at each follow-up visit; corrected monocular defocus curve was measured from − 4.00 D to + 2.00 D in -0.5 D defocus steps at 3 months.

Measurement of CND visual acuity (CNDVA) was done subjectively: covering their non-testing eyes, the patients were required to read the orientation of each E letter from left to right and from top to bottom, until the letters appeared blurred, focusing on the standard logarithmic visual acuity chart of 40 cm at the best comfortable working distance, such as using a phone or reading. The visual outcomes and distances were recorded. The conversion formula for comfortable near real visual acuity was CNDVA = CND/standard examination distance * measured vision.

The evaluation of near visual comfort involved participants focusing on the same minimum distinguishable letter size and actively rating their visual experience at a CND compared to a standard near distance. Subsequently, a visual disturbance questionnaire was developed, encompassing aspects such as letter clarity and visual health and comfort (VICO) [8]. The first question was: “How does the clarity of letter at CND compare to that at standard near distance?” The answer choices were classified as clearer and easier, unchanged, blurrier and harder. In addition, They were asked following questions: “How is the level of eye fatigue at the CND?” and “How is the level of eye fatigue at the standard near distance?” A 5-point reaction scale ranging from “none” to “intense” was utilized to gauge the severity of the participants’ most pronounced eye fatigue (Table 1).

Table 1 Visual health and comfort assessment level
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Intraocular lenses and surgery

The TECNIS® Symfony, ZXR00V (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) is an elongated focus optic pattern that incorporates a diffractive echelette design, which allows light to be continuously focused to restore vision from intermediate to distant, while near vision is deficient [5, 9, 10]. The incidence of dysphotopsias is declined by reducing the overlap of near and far images [11].

The TECNIS® ZMB00 IOL(MIOL) (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) is a diffractive multifocal IOL, characterized by including two focal points in the optical zone to provide superior far and near vision by adding + 4.0 D and thereby reduce spectacle dependency [12].

The TECNIS® ZCB00 IOL (Johnson & Johnson Vision, Santa Ana, CA, USA) is a biconvex one-piece monofocal IOL with an aspheric design to provide distance vision [13]. This lens is made by hydrophobic acrylic material with a 6.0 mm optical diameter.

An experienced surgeon (MJ) performed phacoemulsification and implantation of IOLs in all patients. The main incision size was 2.4 mm. After capsulorhexis and phacoemulsification, the IOL was inserted into the capsular bag. A topical therapy based on tobramycin and dexamethasone eye ointment was applied for 2 weeks after surgery. The interval between binocular surgeries was 1 month.

Statistical analysis

The statistical analysis was performed using SPSS for Windows software (v. 23.0, IBM Corp.). All quantitative variables are expressed herein as the mean ± standard deviation. The normality of data samples was evaluated with Shapiro-Wilk test. Normally distributed variables were compared with one-way ANOVA, and nonnormally distributed variables were compared with the Kruskal–Wallis test. The qualitative variables are expressed as the number (n) and frequency (%). The mean visual acuity was calculated by converting the decimal forms to the logarithm of the minimal angle of resolution (logMAR). A P value less than 0.05 was considered statistically significant.

Results

A total of 100 eligible eyes were implanted successfully with EDOF IOLs (n = 33), multifocal IOLs (n = 34) or monofocal IOLs (n = 33) (Table 2). The baseline characteristics of the three groups, including age, sex distribution, axial length, corneal and lens thickness, corneal astigmatism and anterior chamber depth were comparable.

Table 2 Demographic statistics and preoperative ocular characteristics
Full size table

Visual acuity

Subjective monocular vision was measured at 3 months after surgery (Table 3). The visual acuity was affected because the patients experienced corneal edema; this was not regarded as a meaningful clinical indicator at 1 day postoperatively. In addition, the three groups achieved mean monocular UDVA less than 0.1 logMAR and CDVA less than 0.0 logMAR at 1 week, 1 month and 3 months postoperatively. The obvious difference in the EDOF group compared with the Multi and Mono groups for mean CDVA was not clinically significant at month 3. The EDOF group established a significant difference in mean UIVA versus that in the Multi and Mono groups (P < 0.001). The mean UNVA and CNDVA in the EDOF group was noninferior to that in the Multi group, and both groups demonstrated superiority to the Mono group after surgery (P ≤ 0.001).

Table 3 Visual outcomes at 3 months after surgery
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Defocus curve

The results of corrected monocular defocus curve exhibited a smooth curve in the EDOF group, two peaks in the Multi group (at 0 D and − 3.0 D, respectively), and one peak in the Mono group (at 0 D) at month 3 after surgery (Fig. 1). The EDOF and Multi groups were significantly different from − 1.0 D to -4.0 D compared with the Mono group. Compared with the Multi group, the EDOF group surpassed the defocus curve from 0 D to − 2.0 D but lagged from − 2.5 D to − 4.0 D.

Fig. 1
figure 1

Graph showing defocus curve of three groups. D diopter, LogMAR logarithm of the minimal angle of resolution

Full size image

Comfortable near distance

Monocular subjective CND in the three groups were collected preoperatively and 1 week, 1 month and 3 months postoperatively (Table 4). There was no clinical change in CND between the preoperative and postoperative periods, although evident individual differences in the distribution of CND among the patients were demonstrated (P > 0.05). The CND was 35.85 cm (range: 26 to 45 cm) in the EDOF group, 31.51 cm (range: 22 to 42 cm) in the Multi group, and 34.65 cm (range: 19.5 to 50 cm) in the Mono group at month 3 after surgery.

Table 4 Comfortable near distance preoperative and postoperative
Full size table
Fig. 2
figure 2

Comparison of mean CNDVA and UNVA in three groups after surgery. a EDOF group. b Multi group. c Mono group. CNDVA = comfortable near distance visual acuity, UNVA = uncorrected near visual acuity (*P < 0.05, **P < 0.01)

Full size image

Comfortable near distance visual acuity

The mean CNDVA results for the EDOF and Multi groups compared with the Mono group established analogous differences to those for UNVA (Fig. 2). Compared with the Mono group, both the EDOF and Multi groups attained a mean monocular CNDVA less than 0.2 logMAR at month 3. However, the mean monocular CNDVA significantly differed in the EDOF and Multi groups versus the mean monocular UNVA but showed noninferiority in the Mono group after surgery. Significant outcomes were observed in the EDOF group at 1 and 3 months and in the Multi group at every visit (P < 0.05).

Visual comfort

When gazing at the minimum distinguishable and identical size letter, the proportion of patients reporting visual clarity at a CND at month 3 was improved among the EDOF, Multi and Mono groups compared with the standard near distance (51.5%, 58.8%, and 51.5%, respectively) (Fig. 3a). In addition, the incidence rated as no visual fatigue by patients at a CND was significantly different from that at a standard near distance in the EDOF, Multi and Mono groups (78.8%, 84.2%, and 45.5% vs. 51.5%, 47.1%, and 27.3%, respectively) (Fig. 3b-c). Only one recipient in the Multi group rated this experience as severely fatigue-inducing and was unable to tolerate it.

Fig. 3
figure 3

Visual experience in three groups at 3 months. a, Comparison of letter clarity between CND and standard near distance. b, The level of recipient’s VICO at CND. c, The level of recipient’s VICO at standard near distance. CND = comfortable near distance, VICO = visual health and comfort

Full size image

Discussion

At present, MIOL can successfully restore near and distance vision and produce satisfactory results in the majority of patients, which was widely used in clinical. Our study indicated the well-known benefits and limitations of EDOF and multifocal IOLs versus monofocal IOLs [14,15,16]. All three groups demonstrated better visual acuity at far. The CDVA was assessed based on patient subjective refraction. For most MIOLs and EDOF IOLs, the results of autorefractors show an overestimation of myopia because of the influence of the refractive or of the diffractive near add [17]. Regarding the UIVA, the EDOF group was superior, while the Multi and Mono groups showed no differences. Compared with the Multi group, the EDOF group displayed comparable monocular UNVA and spectacle independence at near. This could be explained by the fact that when choosing the IOL power for EDOF IOLs, we aim for − 1.0D, whereas for the Multi group, we aim for emmetropia. Previous studies have also highlighted that slight myopia can achieve better near vision for patients with EDOF IOLs after surgery [18, 19]. The research of Xiong et al. [20] also found that compared with the − 0.5 ~ − 0.75D subgroup of refractive target in the EDOF IOL, the − 0.75 ~ − 1.0 D subgroup has better binocular UNVA. This is particularly important for patients who care more about near vision after cataract surgery. From another perspective, it also proves that patients can achieve different near visual results by reserving different myopia. Interestingly, the study also found that 18.2% of patients with Mono IOLs achieved a UNVA of less than 0.2 logMAR and engaged in activities with a range of visual acuity while being spectacle free at near distances, which was confirmed by the result of the defocus curve. A probable explanation is pseudoaccommodation without regard to the cultural background and occupation factors of the patients in the Mono group, which adjusted the anterior chamber depth and increased the range of vision through forward and backward movement of the lens capsule driven by the relaxation and contraction of the ciliary muscle [21]. Another possible explanation could come from corneal asphericity. Therefore, these findings demonstrated that even if the lens was replaced, a small accommodation still existed to effectively expand the depth of vision.

At present, the designs of MIOL focus on achieving good distance, intermediate and near visual acuity based on addition-specific diopters [3, 5]. We hypothesize that patients with MIOLs achieved 0.0 logMAR at a standard near distance, but a great difference was in their comfortable near working distance, which would lead to changes in the CNDVA and affect visual comfort. However, few relevant studies have investigated the CND vision and visual comfort of MIOL. Previous studies have demonstrated that the visual comfort can remain efficient in near-range tasks and can become stronger to resist fatigue during high-intensity and long-duration near work [6]. The present study measured the distribution of the CND preoperatively and postoperatively among the three groups. The results of the distribution of CND in the three groups were relatively stable after surgery, and there were no clinically significant differences comparing to the distribution before surgery. The study also evaluated the difference in CNDVA compared with UNVA. The CNDVA outcomes agreed with the UNVA outcomes, demonstrating better results in the EDOF and Multi groups compared with the Mono group. However, the CNDVA was lower than the UNVA in the EDOF and Multi groups after surgery. Therefore, there is a significant correlation with the near-focus design of MIOL.

In addition, patient satisfaction after surgery is an important measure of the success of surgery. Prior studies have focused on patient satisfaction with distance vision and visual quality after surgery, but few have evaluated and studied the visual comfort level at near [19, 22,23,24]. In this study, the patients’ close range visual comfort level was evaluated by a subjective quantitative score based on the VICO index [8]. Patient near visual comfort is an important template for judging the close-range vision achieved with MIOL. The present study demonstrated that the EDOF, Multi and Mono groups had clearer and easier vision at CND versus standard near distances (51.5%, 58.8%, and 51.5%, respectively). Few patients were severely fatigued and unable to tolerate their present experience at CND (0.0% of EDOF patients, 2.9% of Multi patients and 0.0% of Mono patients). These outcomes confirmed that the CND was better than the standard near distance in increasing the visual comfort.

Limitations of this study are that the research on visual function at near is still relatively single, and a more detailed exploration is needed in conjunction with various visual disturbances caused by close range vision. All test measurements were conducted on a single eye with normal axial length. Further studies are yet required to assess visual outcomes of patients with bilateral implantation of MIOL or with very high or very low axial lengths. In addition, this study only discussed the close range visual function of three types of IOLs, and further research is needed on the comfortable intermediate distance visual acuity (CIDVA) of IOLs.

In summary, the EDOF and Multi groups exhibited better distance and near vision and spectacle independence than the Mono group. However, the CNDVA was significantly lower than the UNVA in the EDOF and Multi patients. At a CND, patients experienced higher visual clarity and lower incidence of eye fatigue. These observed distinctions were at clinical significance levels. Thus, we surmised that when choosing the IOL power, the residual refraction can be more appropriately reserved to guarantee that the close focus is placed at the patient’s comfortable distance, which may help the patient achieve better near vision and a better visual experience.

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Abbreviations

EDOF:

Extended depth of focus

Multi:

Multifocal

Mono:

Monofocal

IOL:

Intraocular lens

UDVA:

Uncorrected distance visual acuity

UIVA:

Uncorrected intermediate visual acuity

UNVA:

Uncorrected near visual acuity

CDVA:

Corrected distance visual acuity

CNDVA:

Comfortable near distance visual acuity

CND:

Comfortable near distance

D:

Diopter

LogMAR:

Logarithm of the minimal angle of resolution

VICO:

Visual health and comfort

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Acknowledgements

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Funding

This work was supported by the National Natural Science Foundation of China (No. 82171038 and 81974129), Jiangsu Provincial Health Commission Project (No. M2021084), and Nantong Municipal Science and Technology Project (No. MS22022020).

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Authors and Affiliations

  1. Eye institute, Affiliated Hospital of Nantong University, 20 Xisi Road, Nantong, Jiangsu Province, 226001, China

    Junhui Wang, Jiawei Luo, Wenyu Yang, Ruoxin Ren, Yi Xie, Jiaxin Li, Huaijin Guan & Min Ji

  2. Dalian Medical University, Dalian, Liaoning, China

    Junhui Wang & Ruoxin Ren

  3. Medical School of Nantong University, Nantong, Jiangsu, China

    Jiawei Luo, Wenyu Yang, Yi Xie & Jiaxin Li

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  1. Junhui Wang
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Contributions

JHW and MJ were responsible for the design of this study. JHW, JXL, RXR and YX took part in the original investigation and data collection. JHW, WYY and JWL implemented data management, analyses and interpretation. JHW wrote manuscript composition. MJ and HJG is guarantor.

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Correspondence to Huaijin Guan or Min Ji.

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Ethical approval

Human subjects were included in this study. The study was conducted in accordance with the tenets of the Declaration of Helsinki. This study was approved by the Ethics Committees of the Affiliated Hospital of Nantong University (approval ID: 2019-K068). All patients signed a written informed consent.

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Wang, J., Luo, J., Yang, W. et al. Efficacy and comfort following the implantation of extended depth of focus, multifocal, and monofocal intraocular lenses in cataract patients. BMC Ophthalmol 24, 423 (2024). https://doi.org/10.1186/s12886-024-03685-2

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BMC Ophthalmology

ISSN: 1471-2415

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