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. 2025 Sep 3;10(1):e002025. doi: 10.1136/bmjophth-2024-002025

Meta-analysis of defocus curves of monofocal, enhanced monofocal and extended depth of focus IOLs

Sathish Srinivasan 1,2,✉, Cyril Nyankerh 3, Jessie Hull 3, Rajaraman Suryakumar 3
PMCID: PMC12410659  PMID: 40903089

Abstract

Background/aims

Recently, modified monofocal intraocular lenses (IOLs) (proposed mono plus IOLs) have emerged claiming to provide monofocal quality distance vision while enhancing intermediate distance visual performance. The purpose of this study was to conduct a literature review and compare the range of vision following cataract surgery with the implantation of standard monofocal, claimed monofocal plus and extended depth of focus (EDoF) IOLs.

Methods

Literature searches and a meta-analysis were conducted on Embase, PubMed, IOLEvidence App and the Food and Drug Administration premarket approval database. Mean defocus curves were calculated with a random effect model and study quality was assessed.

Results

After eliminating duplicate publications, 36 studies were included in the data extraction process. Standard monofocal IOLs were implanted in 549 eyes, 360 eyes with claimed mono plus IOLs and 1898 eyes with EDoF IOLs. At far viewing acuity, the performance of all three lens categories appeared comparable: all p>0.05. However, at the intermediate distance of 66 cm (−1.5D), and at a near distance of 40 cm (−2.50D), monofocal and mono plus defocus curve acuities exhibited comparable performance: p=0.22 and 0.77 respectively, while EDoF lenses demonstrated better acuity (all p<0.05).

Conclusions

There is a lack of standardisation of defocus curve measurements among published papers included in this meta-analysis. Despite some slight inconsistencies in measurements, the range of vision of standard monofocal IOLs and mono plus IOLs as measured by the defocus curve appears to be similar. The EDoF IOLs in this meta-analysis indicate a potentially better range of vision compared with mono plus and monofocal IOLs.

Synopsis

This meta-analysis seems to indicate that EDoF IOLs may have a better range of vision as measured by defocus curves compared with mono plus and monofocal IOLs.

Keywords: Lens and zonules, Cataract, Clinical Trial

WHAT IS ALREADY KNOWN ON THIS TOPIC

  • The range of vision provided by an intraocular lens (IOL) is often assessed clinically through the monocular defocus curve.

  • Published studies have used visual outcomes to assess IOL performance in the past.

  • Randomised controlled trials especially with mono plus IOLs are lacking.

WHAT THIS STUDY ADDS

  • This comparative meta-analysis examined the clinical evidence with monofocal, claimed mono plus and extended depth of focus (EDoF) IOLs.

  • The range of vision of standard monofocal IOLs and mono plus IOLs, as measured using defocus curves, was similar.

  • The EDoF IOLs in this meta-analysis demonstrated better ranges of vision compared to mono plus and monofocal IOLs consistent with the expectations for this technology.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

  • This paper will help physicians to customise their IOL selection based on patients’ visual needs and lifestyle when making their IOL selection decisions.

Introduction

Cataract surgery is one of the most common surgeries performed worldwide and it can be considered among the most successful treatments in medicine.1 Monofocal intraocular lenses (IOLs) have been used to restore distance vision, and the patient typically has had to use spectacle correction for intermediate and near vision. The growing demand for optimal vision during intermediate tasks, such as computer use, while preserving distance vision quality led to the development of extended depth of focus (EDoF) lenses.2 EDoFs are non-accommodative lenses that provide simultaneous optical and functional vision at far and also through intermediate focal distances.3 IOL standards have adopted criteria to define the clinical performance expected of an EDoF IOL as set out by the American National Standards Institute (ANSI) and the International Organization for Standardization (ISO).3 4 One of such requirements is for the mean monocular photopic visual acuity at 66 cm with distance-corrected acuity of≤0.20 logMAR. In 2019, a new type of IOLs, branded from a marketing standpoint as ‘monofocal plus’ IOL, has emerged claiming to provide distant visual acuity while enhancing intermediate distance performance.5 However, these IOLs have not met all the EDoF standard criteria and questions still remain if these lenses provide better intermediate vision outcomes and/or range of vision compared with standard monofocal IOLs.

The range of vision provided by an IOL is usually assessed clinically through the monocular defocus curve.3 6 7 Defocus curves measure the range of useful vision provided by the IOL through the measurement of visual acuity for various vergence (defocus) ranges by using trial lenses of different fixed powers. Visual acuity is assessed under standardised test conditions (with best distance correction in place) for each trial lens and using distance visual acuity chart. Alternatively, such a range of vision testing may instead be performed with chart testing at the appropriate focal distances instead of using lenses. It is recommended that the letters be presented randomly to avoid memorisation.8 Removing any confounding effects of binocular summation or refractive error, best-corrected monocular defocus curves can be used to compare the range of vision performance of various IOL optical designs to one another.6 Numerous published studies have used visual outcomes to assess IOL performance in the past;9,25 however, randomised controlled trials (RCTs), especially on the claimed mono plus IOLs, are lacking. Therefore, a meta-analysis of published data may be the most robust way to understand the expected performance of this IOL category relative to monofocal or EDoF.

The purpose of this study was to compare the range of vision outcomes following cataract surgery with the implantation of monofocal, claimed ‘mono plus’ and EDoF IOLs. This was accomplished by conducting a literature search on historic monocular defocus curve data and performing a defocus curve analysis on these IOLs. To the best of our knowledge, this is the first peer-reviewed meta-analysis of defocus curves to compare the performance of standard monofocal, ‘mono plus’ and EDoF IOLs.

Materials and methods

This review focuses on studies involving patients who underwent cataract surgery with bilateral implantation of standard monofocal IOLs, claimed mono plus IOLs and EDoF IOLs in the capsular bag that reported a photopic, high contrast distance-corrected monocular defocus curve.

The Cochrane meta-analysis characteristics were followed. We included only studies that reported means and SD or any other measure of dispersion for IOLs currently in the market. Given that monocular defocus curves are typically presented graphically, the criteria specify that included studies should provide monocular curves with both mean values and error bars. For studies that displayed defocus curves using figures, the WebPlotDigitizer tool and the GRABIT function in MATLAB were used to extract data from the images. Additionally, we included only studies that evaluated and reported true defocus as a function of acuity using corrected distance refraction under photopic conditions, with IOL implantation for eyes with cataracts only within the categories covered by the study.

We conducted an extensive literature search on 12 December 2024 in Embase using the search terms ('defocus curve'/exp OR 'defocus curve' OR 'defocus profile' OR 'defocus testing' OR 'monofocal iol' OR 'enhanced monofocal iol' OR 'monofocal plus iol' OR 'extended depth of focus iol' OR 'edof iol'). In addition, the search terms used in Pubmed included ((“Defocus Curve”[MeSH] OR “Defocus Curve”[Title/Abstract] OR “Defocus Profile”[Title/Abstract] OR “Defocus Testing”[Title/Abstract] OR “Monofocal Intraocular Lenses”[MeSH] OR “Monofocal IOL”[Title/Abstract] OR “Enhanced Monofocal IOL”[Title/Abstract] OR “Monofocal Plus IOL”[Title/Abstract] OR “Extended Depth of Focus Intraocular Lenses”[MeSH] OR “EDoF IOL”[Title/Abstract]). The retrieved studies were then imported into Celegence’s CAPTIS platform where duplicates and studies not meeting the inclusion criteria were deleted. Also, we searched the IOLEvidence application (Qvision Academy) and the Food and Drug Administration premarket approval database Summaries of Safety and Effectiveness (SSEDs) for monocular defocus curve data.

The metamean function in the R meta package was used for the meta-analysis to calculate the overall mean from studies reporting means using the inverse variance method for pooling. We used a random effects model by assuming that the observed effect sizes in each study are a combination of the true effect size (common across all studies) and a random error term. This method accounts for both within-study variability and between-study variability. The random effect model is expressed as follows:

Yi = μ + ϵi + δi

Where Yi=observed effect size in study i,

μ=overall true effect size

ϵi=within-study random error

δi=between-study random effect.

We assessed the I2 statistic to assess heterogeneity, which represents the proportion of total variability due to between-study variability. To estimate the range of focus, we fitted the data to the average visual acuity for each defocus level. A linear interpolation model (using the linearinterp option in MATLAB) was applied to predict the point where the 0.2 logMAR intersects the curve for any negative vergence starting from 0D. A Baujat plot was used to conduct sensitivity analysis to assess the robustness of the results to variations in inclusion criteria. The quality of the studies was assessed by two raters using the Newcastle-Ottawa scale. This scale was selected due to the nature of the majority of the studies included (non-RCT).

Patient and public involvement

Patients and the public were not involved in this meta-analysis.

Results

In total, 1160 records were identified from Embase, 912 from PubMed, 77 from the IOL Evidence app (V.1.2.3) and 3 from the publicly available safety and effectiveness data summaries (figure 1). After removing duplicate publications and screening articles based on their titles and abstracts, the database screening resulted in a total of 149 articles. Following a full-text review, 113 papers were excluded, leaving 36 studies that were included in the data extraction process.1019 21 22 26,58 These comprised 8 RCTs, 24 prospective studies and 4 retrospective studies (figure 1).

Figure 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. The PRISMA diagram details the search and selection process applied during the overview. IOLs, intraocular lenses.

Figure 1

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Demographics

Each publication included underwent a quality assessment and no publication was excluded based on its quality score. 19 of the studies identified were classified as good in quality using the Newcastle-Ottawa scale (online supplemental table 1).

Table 1 presents the characteristics of the included studies, detailing the number of eyes implanted with different types of IOLs. The table summarise lens brands by category that provided published data meeting the requirements for meta-analysis.

Table 1. Characteristics of included studies.

Study Study design No. of eyes (monofocal) No. of eyes (mono plus) No. of eyes (EDoF) Model of IOLs studied
Bala et al 2022 RCT 106 145 SN60WF IQ AcrySof/ Vivity DFT015
Baur et al 2021 PS 38 Xact ME4
Bohm Myriam et al 2019 PS 52 Symfony ZXR00
Liu Xin et al 2019 PS 45 Symfony ZXR00
Nanavaty et al 2022 RCT 50 50 RayOne/ Eyhance ICB00
Pedrotti et al 2016 PS 30 50 Tecnis ZCB00/Symfony ZXR00
Steinmuller et al 2022 PS 30 30 Tecnis ZCB00/Eyhance ICB00
Jia Xu et al 2022 PS 131 Symfony ZXR00
Danzinger et al 2024 PS 24 IsoPure 123
Grabner et al 2015 PS 12 IC-8
Symfony SSED RCT 62 Symfony ZXR00
IC-8 SSED PS 340 IC-8
Vivity SSED RCT 111 107 SN60WF IQ AcrySof/ Vivity DFT015
Sugawara et al 2023 RS 39 Eyhance ICB00
Danzinger et al 2024 PS 25 Isopure 123
Asena et al 2023 PS 52 Vivity DFT015
Mastropasqua et al 2023 PS 30–30 Mini Well/ Mini Well Proxa
Zhu et al 2022 RS 40 Symfony ZXR00
Kohnen et al 2022 PS 32 Vivity DFT015
Wurth et al 2022 PS 24 Synthesis Plus
Tahmaz et al 2022 PS 56 LuxSmart
Tañá-Sanz et al 2021 RS 50 xact Mono-EDoF
Greve et al 2021 PS 28 28 Mini Well/ Mini 4
Amaro et al 2024 PS 40 Acunex Vario AN6V
Iradier et al 2021 PS 27 Synthesis Plus
Song et al 2020 PS 47 47 Lentis L313/Symfony ZXR00
Kohnen et al 2019 PS 52 Symfony ZXR00
Corbett et al 2024 RCT 54 55 Eyhance ICB00/TECNIS PureSee
Fernandes et al 2024 RCT 120–132 Symfony ZXR00/Vivity DFT015
Law et al 2020 RCT 47 Bi-Flex 677
Wendelstein et al 2024 RS 29 29 CT Spheris 204/AT LARA 829
Spagnuolo et al 2024 PS 25–25 Evolux / Eyhance ICB00
Guo et al 2022 PS 160 Symfony
Alio et al 2011 PS 22 Acri Smart 48S
Alio et al 2010 PS 24 Acri Smart 48S
Cleary et al 2010 RCT 25 SN60WF IQ AcrySof
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EDoF, extended depth of focus; PS, prospective study; RCT, randomised controlled trial; RS, retrospective study; SSED, Summary of Safety and Effectiveness.

Standard monofocal IOLs were implanted in 549 eyes, 360 eyes with claimed mono plus IOLs and 1898 eyes with EDoF IOLs (meeting ANSI Z80-35:2018 and ISO 1179-7:2024 EDoF criteria).3 4 Notably, the monocular defocus curve data for one monofocal lens from the ‘Summary of Safety and Effectiveness Document (SSED) for the Tecnis Symfony Extended Range of Vision IOLs’ was later excluded from the analysis due to its substantial contribution to overall heterogeneity, as evidenced by the Baujat plot (online supplemental figure 1a).56 In this case, heterogeneity refers to the variability among the studies being combined. It can arise due to differences in study design, participant characteristics, interventions, how the outcome was measured, etc. Therefore, if the studies being combined are too different from each other, the validity and reliability of the overall estimate could be compromised. No major outliers were identified, and the data were more homogeneous in the mono plus and EDoF data sources (online supplemental figure 1b, c).

As expected, all monocular defocus curves yielded a peak at a defocus value of 0.00D (figure 2). The EDoF IOLs exhibited a flatter curve, in contrast to the monofocal and mono plus IOLs, which showed abrupt declines from 0D. The negative depth of focus at 0.2 logMAR for monofocal, mono plus and EDoF IOLs was −1.17D, −1.28D and −1.81D, respectively. There were no statistically significant nor clinically relevant differences in visual acuity observed between monofocal and mono plus IOLs at any defocus level; all differences were p>0.05 (online supplemental table 2). Noteworthy differences in acuity were statistically significant between the monofocal and EDoF IOLs at defocus levels of −1.0D to −2.5D (all p<0.05). The EDoF lenses exhibited a similar broader defocus curve, showing statistically significant differences from mono plus IOLs at defocus levels of −1.0D to −2.5D (all p<0.05). Beyond −1D, the EDoF lenses demonstrated a clinically relevant improvement of>1 line in performance compared with both monofocal and mono plus IOLs (table 2).

Figure 2. The mean monocular defocus curves measured within the three distinct lens groups. Monofocal lenses (red line), mono plus lenses (green line) and EDoF lenses (blue line). Error bars represent 95% CI. EDoF, extended depth of focus.

Figure 2

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Table 2. Results of meta-analysis for defocus curves.

Monofocal IOLs Mono plus IOLs EDoF IOLs
VA (logMAR) VA (logMAR) VA (logMAR)
Defocus (D) Mean (95% CI) Defocus (D) Mean (95% CI) Defocus (D) Mean (95% CI)
1.50 0.39 (0.34 to 0.45) 1.50 0.35 (0.30 to 0.41) 1.50 0.40 (0.35 to 0.44)
1.00 0.21 (0.18 to 0.25) 1.00 0.18 (0.13 to 0.22) 1.00 0.23 (0.20 to 0.26)
0.50 0.06 (0.04 to 0.09) 0.50 0.05 (0.03 to 0.08) 0.50 0.10 (0.07 to 0.12)
0.00 −0.03 (−0.06 to 0.00) 0.00 −0.04 (−0.07 to 0.00) 0.00 −0.00 (−0.02 to 0.01)
−0.50 0.05 (0.03 to 0.07) −0.50 0.03 (0.00 to 0.05) −0.50 0.05 (0.03 to 0.07)
−1.00 0.18 (0.15 to 0.21) −1.00 0.13 (0.10 to 0.16) −1.00 0.09 (0.07 to 0.11)
−1.50 0.31 (0.27 to 0.34) −1.50 0.26 (0.23 to 0.30) −1.50 0.14 (0.11 to 0.17)
−2.00 0.45 (0.41 to 0.49) −2.00 0.40 (0.37 to 0.43) −2.00 0.24 (0.20 to 0.27)
−2.50 0.60 (0.57 to 0.63) −2.50 0.55 (0.52 to 0.58) −2.50 0.36 (0.32 to 0.41)
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Mean= pooled mean acuity estimate, 0.00D=distance, −1.50D=intermediate distance equivalent to 66 cm and −2.50D=near distance equivalent to 40 cm.

EDoF, extended depth of focus; IOLs, intraocular lenses; VA, visual acuity.

Discussion

This comparative meta-analysis examined the clinical evidence concerning monofocal, claimed mono plus and EDoF IOLs. It includes 8 RCTs, 24 prospective studies and 4 retrospective studies. In addition, 20 of the studies identified were classified as good in quality using the Newcastle-Ottawa scale. Well-defined criteria have been established by the ANSI and ISO standards for standard monofocal and EDoF lenses. The definition of EDoF, as outlined by the American National Standard Z80.35–2018 (ANSI), specifies four key effectiveness benchmarks that an IOL must fully meet to be considered an EDoF.4 These criteria include: (1) the need to demonstrate statistical superiority over a control monofocal group in terms of mean, monocular photopic distance-corrected intermediate visual acuity at 66 cm; (2) the requirement to exhibit a minimum of 0.5 D greater monocular photopic negative lens-induced distance-corrected depth of focus compared with the monofocal control IOL at a 0.2 logMAR visual acuity threshold; (3) the median value of monocular distance-corrected photopic intermediate visual acuity at 66 cm must be at least 0.2 logMAR; and (4) the mean monocular photopic best-corrected distance acuity for the EDoF IOL must statistically prove non-inferiority to the control, with a non-inferiority margin of 0.1 logMAR. Requirements by ISO for EDoF lens classification are very similar.3

We would like to point out that the EDoF IOLs analysed in this meta-analysis met all four prescribed criteria as has been established by one or more studies. This may be why the EDoF group as defined in this meta-analysis showed a significant and clinically relevant improvement in the defocus curve for the intermediate to near range (−1.5D to −2.5D) over the other two IOL groups. Furthermore, there were no statistically significant differences observed across any vergence points in the through-focus curves between the monofocal and mono plus groups. This emphasises the limited relevance of any potential numerically superior performance within these cohorts. The monofocal marketplace already incorporates various approaches that inherently provide a degree of depth of focus, such as lenses with different asphericities or spherical models, and variations in shape factors, among others.59 Given that a clinically perceptible difference is typically±0.25D (minimum step in the phoropter or trial lens), it becomes evident that the EDoF lenses analysed in these meta-analyses offer a significantly broader range of vision (1.81D) compared with both the monofocal (1.17D) and mono plus groups (1.28D). Furthermore, the difference between the monofocal and mono plus groups appears to be modest and clinically insignificant, as the range of vision difference between them amounts to only 0.11D.

Both monofocal and mono plus lenses offer some degree of intermediate vision, with monocular visual acuities at −1.5D (intermediate vision) reaching approximately 0.3 logMAR (20/40). These values are expected to improve in binocular vision and may provide adequate acuity for performing certain activities at intermediate without correction. An inherent limitation of visual acuity measurement techniques when visual acuity levels are not optimal (ie, logMAR 0.0) is the higher SD, indicating greater variability among subjects. Therefore, determining the threshold of clinical relevance, particularly when differences in visual acuity are lower than one line in a logMAR 0.3 range like in the case of monofocal and mono plus groups in this work, presents a challenge and may require further discussion and investigation. Also, the degree of spectacle independence offered at intermediate vision, which is likely to be a clinically significant endpoint from the patient’s perspective, remains uncertain and is beyond the scope of this meta-analysis.

Fernández et al60 conducted a recent cluster analysis of monocular defocus curves, and the European Society of Cataract and Refractive Surgeons (ESCRS) Functional Vision working group proposed a functional classification of IOLs based on the cluster analysis. In the proposed functional classification enhanced monofocal IOLs should exhibit a mean best corrected negative range of defocus at 0.2 logMAR or better of≥1.2 D and<1.58D while EDoF IOLs should achieve≥1.58 to <2.3D negative range of defocus.61 The monocular negative range of defocus at 0.2 logMAR for each lens category we found in our meta-analysis was within the range proposed by this working group, although on the lower end of both the enhanced monofocal and EDoF groups. This may be due to the differences in published studies included as we included a subset of studies used by Fernández et al60 as previously described to ensure proper meta-analysis technique.

A notable observation made by the authors is the variation in how defocus curves are performed across studies. Defocus curves assess visual acuity either at various object distances from the patient62 63 or through different levels of defocus induced using trial lenses.64 65 Of these two methods, measuring acuity at different physical distances is often impractical due to the need to control angular image size and target luminance. Conversely, lens-induced defocus is affected by lens-induced magnification.66 Due to the lack of standardisation in these approaches, various metrics have been proposed to provide a more standardised bias-free assessment of lens performance.67 Interestingly, only one paper in the reviewed literature explicitly mentioned using the metric suggested by Buckhurst and colleagues.67 All included studies used trial lenses to induce defocus. Approximately half of these reported using some form of letter randomisation to mitigate memorisation bias. However, it is possible that other studies also adopted letter or other randomisation techniques but did not explicitly report it. As this review did not aim to evaluate test standardisation in detail, a deeper methodological comparison was beyond its scope. Nonetheless, future studies would benefit from clearly reporting testing distance methods, use of randomised optotypes and test distances and implementation of standardised comparative approaches to improve the interpretability and reproducibility of defocus curve analyses.

One of the key strengths of this study lies in its comprehensive approach, encompassing various IOL categories and multiple brands within each category. This extensive approach allowed for both pooled and subgroup analyses, facilitating the identification of subtle distinctions between different lens categories. Furthermore, we only included data that facilitated the most robust meta-analysis, incorporating more than just weighted mean values. Using a monocular distance-corrected defocus to evaluate and compare range of vision performance is desired to consider a full range of distances, eliminate the effect of the binocular summation and remove any intended or unintended refractive error. Defocus curves provide an accurate method of revealing differences in visual acuity between IOLs at varying levels of defocus. A good understanding of IOL defocus curves can help the surgeon to select the option that best meets the visual acuity needs at specific distances of each individual patient.47

Limitations

The monocular defocus curve data for the ZCB00 lens from the Symfony SSED was excluded from the analysis due to its substantial contribution to overall heterogeneity (online supplemental figure 1a). However, this exclusion did not alter the overall findings or conclusions drawn from the study. Despite our comprehensive search strategy and inclusion criteria, we acknowledge the possibility that some relevant studies may have been missed. However, we believe that any such omissions are unlikely to substantially impact the findings or conclusions of this meta-analysis, given the consistency of results across included studies.

Given the absence of a standardised performance criteria for mono plus lenses, the current results can help inform surgeons of the relative depth of focus performance of various IOL types to guide IOL selection discussions; as well as guide the development of the next generation of IOLs. More robust clinical studies are needed to strengthen the assessment of the performance of different IOLs under the different categories, especially for mono plus lenses.

Supplementary material

online supplemental file 1
bmjophth-10-1-s001.tif (20.5MB, tif)
DOI: 10.1136/bmjophth-2024-002025
online supplemental file 2
bmjophth-10-1-s002.docx (29.7KB, docx)
DOI: 10.1136/bmjophth-2024-002025
online supplemental file 3
bmjophth-10-1-s003.docx (27.2KB, docx)
DOI: 10.1136/bmjophth-2024-002025

Acknowledgements

Medical writing assistance was provided by Julie Crider, PhD, of Kandha (Austin, Texas, USA), and was funded by Alcon Laboratories, Inc (Fort Worth, Texas, USA).

Footnotes

Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Not applicable.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Data availability statement

No data are available.

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Associated Data

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Supplementary Materials

online supplemental file 1
bmjophth-10-1-s001.tif (20.5MB, tif)
DOI: 10.1136/bmjophth-2024-002025
online supplemental file 2
bmjophth-10-1-s002.docx (29.7KB, docx)
DOI: 10.1136/bmjophth-2024-002025
online supplemental file 3
bmjophth-10-1-s003.docx (27.2KB, docx)
DOI: 10.1136/bmjophth-2024-002025

Data Availability Statement

No data are available.

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