Optical and visual outcomes of a new refractive extended depth of focus intraocular lens

• Vol. 41, No. 4, 2025 e333 RESEARCH ARTICLE In recent years, the field of ophthalmology has seen significant advancements in intraocular lens (IOL) technology. Monofocal IOLs are known to provide excellent far vision after cataract surgery, but the patient usually requires spectacles for any other distance. On the other hand, multifocal designs, which are now mostly based on diffractive optics, overcome the spectacle dependence by providing two or three differentiated peaks of vision but are associated with a higher risk of glare, halos, lower contrast sensitivity,1 and alterations in spatio-chromatic vision.2 To address the evolving visual needs of the population after lens surgery, extended depth of focus (EDOF) technology ideally bridges the clinical shortcomings between ABSTRACT PURPOSE: To characterize the optical design and analyze the optical quality and halo induced by the new extended depth of focus (EDOF) TECNIS PureSee intraocular lens (IOL) (Johnson & Johnson Surgical Vision) and to evaluate its clinical performance. METHODS: The power profile of the TECNIS PureSee was measured with the NIMO TR1504 device (LAMBDA-X). The through-focus modulation transfer function area (TF-MTFa) metric from +2.00 to -4.00 diopters (D) and the halo induced by the IOL in the best focus plane for distance vision (0.00 D), were assessed for 2-, 3-, and 4.5-mm aperture diameters at the IOL plane. The clinical evaluation in a cohort of patients included postoperative refraction, visual acuities, defocus curve, and subjective symptomatology. RESULTS: The power profile shows distinct zones that meet relatively smoothly. The largest power change occurs in the central zone of the lens. The TF-MTFa curves showed an increase in depth of focus for smaller pupils. Larger pupils resulted in smaller, lower-intensity halos. For 2-, 3-, and 4.5-mm pupils, halo sizes were 18.64, 14.73, and 13.23 arcmin, respectively, and normalized energies were 0.55, 0.46, and 0.42, respectively. Clinical assessment yielded excellent visual and refractive outcomes, a depth of field from +1.00 to -2.00 D with visual acuities better than 0.2 logarithm of the minimum angle of resolution, and with almost no dysphotopic symptoms. CONCLUSIONS: The TECNIS PureSee IOL provided good distance optical and visual quality and an extended depth of field of approximately 2.00 D. The depth of focus increased for smaller pupils. The halo induced by the lens was of low size and energy. [J Refract Surg. 2025;41(4):e333-e341.] From Fernández-Vega Ophthalmological Institute, Oviedo, Spain (BA-B, LF-V-C, JFA); Clinical and Experimental Eye Research, Optometry and Vision Department, Faculty of Optics and Optometry, Universidad Complutense de Madrid, Madrid, Spain (IM-A); Applied Optics and Image Processing Research Group, Department of Optics and Optometry, Universitat Politècnica de Catalunya BarcelonaTech, Terrassa, Spain (FC, FV, MSM); and Clinical and Experimental Eye Research, Optometry and Vision Department, Faculty of Optics and Optometry, Universidad Complutense de Madrid, Madrid, Spain (DM-C). © 2025 Alfonso-Bartolozzi, Martinez-Alberquilla, Fernández-Vega-Cueto, et al; licensee SLACK Incorporated. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (https://creativecommons.org/licenses/ by-nc/4.0). This license allows users to copy and distribute, to remix, transform, and build upon the article non-commercially, provided the author is attributed and the new work is non-commercial. Funding: Supported by project PID2020-114582RB-I00/AEI/10.13039/501100011033 (FC, FV, MSM) from the Spanish Agencia Estatal de Investigación. Disclosure: The authors have disclosed no potential conflicts of interest, financial or otherwise. Address correspondence to José F. Alfonso, MD, PhD, Fernández-Vega Ophthalmological Institute, Avda. Dres. Fernández-Vega 114, 33012 Oviedo, Spain; email: [email protected]. Submitted: November 25, 2024. Accepted: February 21, 2025. Published online: April 1, 2025. doi: 10.3928/1081597X-20250221-02 Optical and Visual Outcomes of a New Refractive Extended Depth of Focus Intraocular Lens Belén Alfonso-Bartolozzi, MD, PhD; Irene Martinez-Alberquilla, PhD; Luis Fernández-Vega-Cueto, MD, PhD; Fátima Cuellar, MSc; Fidel Vega, PhD; María S. Millán, PhD; David Madrid-Costa, PhD; José F. Alfonso, MD, PhD e334 monofocal and multifocal designs.3 EDOF IOLs aim to increase the depth of field while minimally affecting distance vision4,5 and minimizing dysphotopic phenomena. Diffractive designs were the pioneering technology within the EDOF IOL family.6 However, they were often associated with reduced contrast sensitivity and the development of dysphotopic symptoms in low-light conditions.3 Since then, multiple technologies have been developed to provide this extended range of vision, such as using the pinhole principle to elongate the focus, modifying the spherical aberration, or using bianalogic designs.5 Within this variety of options, new EDOF designs are being launched into the market, such as the TECNIS PureSee IOL (DEN00V model; Johnson & Johnson Surgical Vision). According to the manufacturer, this is a purely refractive lens designed to deliver uninterrupted and high-quality vision at different distances while maintaining low levels of dysphotopic phenomena typical of monofocal IOLs. However, to fully understand how these design goals are addressed, it would be interesting to know the IOL power profile across the lens aperture, which, to date, has not been disclosed by the manufacturer. In addition, there are so far few peer-reviewed publications reporting on optical and visual results with the TECNIS PureSee IOL.7,8 Therefore, this study had three objectives. First, to characterize the optical design of this new EDOF TECNIS PureSee DEN00V IOL by experimentally determining the lens power profile. Second, to analyze in vitro its optical quality and halo formation. Finally, to evaluate the clinical performance of this IOL in a cohort of patients after cataract surgery. PATIENTS AND METHODS IOL The TECNIS PureSee DEN00V IOL is defined by the manufacturer as a purely refractive presbyopic-correcting IOL with continuous-power technology. It is a singlepiece aspheric foldable lens manufactured in hydrophobic soft acrylic material with an Abbe number of 55 and refractive index of 1.47 (35 °C) and designed to be placed in the capsular bag. The IOL features an anterior aspheric surface intended to compensate for the average spherical aberration of the cornea, whereas its posterior refractive surface is engineered to provide a continuous change in power, thereby extending the depth of focus. In this study, the in vitro measurements (power profile, optical performance, and halo induced) were done with a lens of nominal 20.00 diopters (D) base power. POwer PrOfILe MaPPIng and wavefrOnt anaLysIs The NIMO TR1504 device (LAMBDA-X) was used to map the power profile of the IOL. The working principle of this device is based on a phase-shifting Schlieren technique that combined with a phaseshifting method allows the measurements of the light deviations,9 which can be used to calculate the power characteristics of the lens within the optical zone.10-13 OPtIcaL PerfOrMance The test bench used to evaluate the optical performance of the TECNIS PureSee IOL has been previously described by our group.14,15 In brief, the optical bench, which is American National Standards Institute (ANSI) Z80.35-2018 compliant,16 is formed by an illumination system, a model eye, and an image acquisition system. Specifically for this study, we employed a high-power broadband green LED (SOLIS 565C; Thorlabs GmbH) combined with a narrow bandpass interferential filter with transmission peak at 550 nm and full width at half maximum of 10 nm. The model eye has an artificial cornea that mimics the spherical aberration of the average human cornea (Zernike coefficient Z4 0 = +0.27 µm for a 5.15 mm pupil at the IOL plane).16 A microscope and a charge coupled device camera were used to acquire the image formed by the model eye with the IOL inserted. The best focus plane for distance (0.00 D defocus) was determined according to the ANSI guidelines as the position of maximum modulation transfer function (MTF) value (at 50 cycles/mm) with the 3-mm aperture. The optical performance was evaluated via through-focus MTF (TF-MTF) at 50 cycles/mm and TF-MTF area (TF-MTFa), the latter calculated as described in earlier publications14,15,17 and summarized here for the sake of completeness. First, the MTF was measured across a range of focal positions, from +2.50 to -5.00 D in 0.10-D steps. In each position of this range, the area under MTF was calculated by integrating the corresponding MTF curve on the spatial frequencies range from 0 to 50 cycles/mm. The TF-MTFa was obtained for aperture diameters of 2-, 3-, and 4.5-mm in the IOL plane corresponding to approximately 2.3-, 3.5-, and 5.2-mm, respectively, in the entrance pupil plane of a patient’s eye, the latter being the parameter measured in the clinic. Unless otherwise specified, from now on the pupil apertures will be referred to as the IOL plane. Finally, from the TF-MTFa measurements with a 3-mm pupil we calculated the simulated visual acuity in the +1.00 to -3.00 D defocus range using the formula recommended in ANSI.16 HaLO assessMent The halo induced by the TECNIS PureSee IOL was measured as described elsewhere14,18-20 employing the same model eye used for the evaluation of the optical • Vol. 41, No. 4, 2025 e335 performance. The halo assessment was performed with a 200-µm pinhole as the test object and a high-power LED warm white light source (SOLIS-2C; Thorlabs GmbH), combined with a bandpass filter (PE530-25.5; MidOpt.Inc) whose spectral transmittance simulates the photopic response of the human eye, to align with ANSI recommendations.16 The camera recorded the image of the pinhole test formed at the best focus plane for distance vision (0.00 D) by the model eye with the TECNIS PureSee IOL. Typically, the digital image showed central core with a surrounding halo. The energy in each of these two regions was computed and normalized to the total energy of the image. Additionally, and in accordance with ANSI guidelines, the images will be reported in two ways: as printed images using a gamma correction of 0.5 to clearly show the halo and as a radial light intensity graph, with visual angle plotted on the Xaxis and the logarithmic value of the light intensity on the Y-axis. These halo measurements were performed for 2-, 3-, and 4.5-mm aperture diameters. Additionally, halo measurements were also taken for +0.50 and -0.50 D of defocus to assess the effect that mild postoperative refractive errors might have on the halo formation. Such a defocus was only induced for a 4.5mm aperture (5.2 mm at the patient’s entrance pupil), representative of night vision (mesopic conditions). cLInIcaL assessMent The clinical study involved patients who underwent bilateral cataract surgery with implantation of the TECNIS PureSee IOL at Fernández-Vega Ophthalmological Institute (Oviedo, Spain). This study conformed to the principles of the Declaration of Helsinki and all enrolled participants signed the informed consent. Patients between 65 and 85 years with no previous ocular surgeries, irregular corneal astigmatism, ocular abnormalities, or conditions contraindicated in IOL implantation were included in the study. Exclusion criteria included corneal astigmatism of greater than 1.50 D and axial length outside the range of 22 to 25 mm. A complete ophthalmological examination was performed prior to study procedures, including refraction, corneal topography, slit-lamp biomicroscopy, and tonometry. The Barrett Universal II formula was used for IOL power calculation, targeting emmetropia. All surgeries were performed by the same experienced surgeon (JFA) following the same procedure as previously described in other investigations.13 A femtosecond laser (CATALYS Precision System; Johnson & Johnson Surgical Vision) was used to carry out the anterior capsulotomy and fragmentation of the nucleus. A capsular tension ring (AC001102, 11/10 diameter; AJL Ophthalmic) was implanted in all cases, aiming to provide capsular bag stability and facilitate the IOL centration. Postoperative visits were performed 1 day and 1 and 3 months after implantation. At 3 months postoperatively, the study protocol to evaluate the clinical outcomes consisted of manifest refraction, monocular uncorrected (UDVA) and corrected (CDVA) distance visual acuities at 100% contrast under photopic conditions (85 cd/m2), and monocular defocus curve (the right eye of each patient) evaluated from +2.00 to -5.00 D in 0.50-D steps. Finally, the practitioner showed all patients images of representative halos and glare, asking them to indicate whether they experienced such visual disturbance and, if so, the frequency (rare, sometimes, most of the time, always) and how bothersome it was (slight, medium, moderate, severe). Data analysis was performed using SPSS for Windows software, version 14.0 (SPSS, Inc). Normality was checked with the Kolmogorov-Smirnov test. Visual and refractive outcomes were analyzed at the 3-month postoperative visit. Means and standard deviations or percentages were used to report postoperative visual and refractive results. RESULTS POwer PrOfILe MaPPIng Figure 1 shows the measured sagittal power profile of the 20.00 D TECNIS PureSee IOL. Given the radial symmetry of the measured power map (see the inset of Figure 1), the power profile is plotted as IOL power variation versus radial distance from the center of the lens. The power profile shows distinct zones that meet relatively smoothly. The largest power change is evidenced in the central zone of the lens, where power varies from Figure 1. Power map and power profile for the TECNIS PureSee IOL (Johnson & Johnson Surgical Vision). Vertical axis represents the average sagittal power in diopters, and horizontal axis represents the radial distance in millimeters from the IOL center. Horizontal line represents the nominal power (20.00 diopters [D]). e336 approximately 19.5 D at the center (0.0 mm) up to a maximum of approximately 23.4 D at the radial distance of 0.90 mm. From 1.1 to 1.4 mm, the measured power is practically constant and close to the nominal 20.00 D base power of the IOL. From 1.4 mm outward, there is a smooth decay of the power, reaching approximately 19.00 D at 2.25 mm (the maximum radial distance for which reliable measurements were still obtained). OPtIcaL PerfOrMance Figure 2 shows the TF-MTF at 50 cycles/mm and the TF-MTFa curves for pupil apertures of 2-, 3-, and 4.5-mm. The three TF-MTFa curves (Figure 2B) exhibited a single peak of maximum value at the nominal defocus of 0.00 D. The TF-MTFa values at this point, representing the position of optimal optical quality, were 28.2, 29.0, and 36.6 (a.u.) for the 2-, 3-, and 4.5mm pupils, respectively, demonstrating a consistent positive association with aperture size. As defocus increased, the MTFa curves gradually declined, with distinct variations influenced by pupil size. With smaller pupils the curve broadened, leading to a wider region of slow degradation and sustained image quality. Figure 3 shows the simulated visual acuity from +1.00 to -3.00 D of defocus. The best visual acuity of -0.07 logMAR was achieved at 0.00 D defocus and slightly decreased to 0.09 logMAR at approximately -0.75 D of defocus, remaining constant until -1.75 D, where it begins to decline. The range of vergences from 0.00 D (distance focus) to negative vergences (intermediate and near distances) where visual acuity was equal to or better than 0.20 logMAR was -2.13 D. The simulated visual acuity between -0.50 and +0.50 D (ie, a situation that accounts for possible mild hyperopic or myopic refractive errors postoperatively) remained better than 0.1 logMAR, which indicates that the TECNIS PureSee may have a good tolerance to these errors (± 0.50 D from targeted emmetropia). HaLO assessMent Halo induced by the TECNIS PureSee IOL is represented in Figure 4 for three pupils of 2-, 3-, and 4.5mm diameter. Interestingly and somehow unexpected, smaller apertures resulted in both larger and more intense halos. Thus, normalized halo energies of 0.55 ± 0.01, 0.46 ± 0.01, and 0.42 ± 0.01 with halo sizes of 18.6 ± 0.2, 14.7 ± 0.2, and 13.2 ± 0.2 arcmin were determined with pupils of 2-, 3-, and 4.5-mm, respectively. Additionally, Figure 5 shows the effect of defocus on the halo with a 4.5-mm aperture. Positive defocus (equivalent to myopic defocus) created a wider and more intense halo out of the core. cLInIcaL OutcOMes This clinical study involved 30 eyes of 15 patients (5 men and 10 women) with a mean age of 75.9 ± 4.9 Figure 2. (A) Through-focus modulation transfer function (TF-MTF) at 50 cycles/mm and (B) TF-MTF area (TF-MTFa) curves obtained with the TECNIS PureSee IOL (Johnson & Johnson Surgical Vision) for a 2-, 3-, and 4.5-mm aperture. D = diopters Figure 3. Simulated through focus visual acuity with the TECNIS PureSee IOL (Johnson & Johnson Surgical Vision) calculated from optical bench measurements (Figure 2B) obtained in an eye model for a 3-mm pupil. D = diopters • Vol. 41, No. 4, 2025 e337 Figure 4. Best focus images of the pinhole object test (top) and their intensity profiles (bottom) formed by the eye model with a TECNIS PureSee IOL (Johnson & Johnson Surgical Vision) for a (A) 2-, (B) 3-, and (C) 4.5-mm pupil. A gamma correction of 0.5 is applied to the top images to facilitate the visualization of the halo. Profiles depict the intensity in logarithmic scale. Figure 5. Pinhole object test (top) and its intensity profile (bottom) formed by the eye model with a TECNIS PureSee IOL (Johnson & Johnson Surgical Vision) with a 4.5-mm pupil at (A) -0.50, (B) 0.00, and (C) +0.50 diopters (D) of defocus. A gamma correction of 0.5 is applied to the top images to facilitate the visualization of the halo. Profiles depict the intensity in logarithmic scale. e338 years. Preoperative demographic data of the patients are summarized in Table 1. The mean IOL power was 22.40 ± 2.50 D (range: 19.00 to 26.00 D). The mean postoperative monocular UDVA and CDVA after 3 months were 0.10 ± 0.15 and 0.05 ± 0.09 logMAR, respectively. The mean postoperative sphere and mean cylinder were -0.07 ± 0.23 and -0.42 ± 0.48 D, respectively, with 100% of patients having refractive spheres between +0.50 and -0.50 D. Figure 6 shows the postoperative monocular defocus curve 3 months after TECNIS PureSee IOL implantation. The curve yields one peak of maximum visual acuity at 0.00 D defocus (distance vision). As negative defocus increases (intermediate-near distances), the visual acuity exhibits a progressive and smooth decay. As a result, the visual acuity was 0.2 logMAR (approximately 20/32) or better across the vergence range from 0.00 D to -2.00 D (equivalent to 50 cm from the eye). At the vergence of -2.50 D (40 cm from the eye) the visual acuity was 0.25 ± 0.15 logMAR. Furthermore, the analysis of the visual acuity on the positive range of vergences showed a good tolerance to myopic defocus, with values better than 0.1 logMAR (approximately 20/25) for vergences up to +1.00 D. Regarding visual disturbances symptomatology, no patients complained about glare, and 14 of 15 patients did not report halo. The only patient who experienced such visual disturbance reported it as slightly bothersome and with a rare frequency of occurrence. DISCUSSION The optical quality and clinical performance of EDOF IOLs have garnered significant research interest because of their potential advantages for patients with presbyopia or cataracts. New EDOF designs are being introduced to the market, such as the TECNIS PureSee IOL, which according to the company is a purely refractive lens designed to provide uninterrupted, high-quality vision along with a dysphotopsia profile comparable to a monofocal design. The aim of this study was to carry out a comprehensive manufacturer-independent characterization of the optical design and an evaluation of the optical and visual performance of this new EDOF IOL, the TECNIS PureSee. For this purpose, the power profile of the lens was first measured, followed by analyzing its optical quality and halo formation when inserted in a model eye. Finally, the visual performance was assessed in a clinical setting. As shown in Figure 1, the power profile of the TECNIS PureSee IOL presented differentiated zones across the optical diameter that meet relatively smoothly. The central zone of the lens shows a complex design area, with a continuous change in power from 19.50 D (ie, slightly below the 20.00 D nominal power of the IOL) at the center of the lens, up to a peak power of 23.5 D at the radial distance of 0.9 mm. Then, within this central zone that extends to a radial distance of 1.1 mm, the design of the lens combines a far/near scheme. From a radial distance of 1.4 mm toward the periphery of the optical zone of the TECNIS PureSee IOL, the power smoothly decreases following a similar trend to that previously reported in other TECNIS aspheric lenses13,21 to maintain the same spherical aberration correction (-0.27 µm for a 5.15mm aperture in the IOL plane).7 The features of the power profile shown in Figure 1 are similar to several exemplary designs disclosed by TABLE 1 Preoperative Patient Data Characteristic Mean ± SD (Range) Age (years) 75.9 ± 4.9 (65 to 85) Refractive sphere (D) +0.30 ± 1.96 (-3.00 to +4.00) Refractive cylinder (D) -0.89 ± 0.62 (-1.50 to 0.00) Topographic cylinder (D) 0.70 ± 0.41 (-1.50 to 0.00) Monocular CDVA (logMAR) 0.20 ± 0.17 (0.00 to 0.52) Minimum keratometry (D) 43.71 ± 1.58 (41.50 to 46.50) Maximum keratometry (D) 44.40 ± 1.45 (41.75 to 46.75) ACD (mm) 2.64 ± 0.49 (1.64 to 3.49) ATA distance (mm) 11.69 ± 0.54 (10.98 to 12.80) Photopic pupil diameter (mm) 3.11 ± 0.87 (2.14 to 5.05) Mesopic pupil diameter (mm) 4.51 ± 0.80 (3.06 to 6.00) Axial length (mm) 23.26 ± 0.80 (22.24 to 24.75) ACD = anterior chamber depth; ATA = angle-to-angle; CDVA = corrected distance visual acuity; D = diopters; logMAR = logarithm of the minimum angle of resolution; SD = standard deviation Figure 6. Mean postoperative monocular visual acuity (logarithm of the minimum angle of resolution [logMAR]) with best correction for distance as a function of the chart vergence. Error bars represent the ± standard deviation of the measurements. D = diopters • Vol. 41, No. 4, 2025 e339 Faria-Ribeiro et al,22 which were based on optical powers that vary as cosine functions of the radial position inside different zones to obtain EDOF IOLs. In addition, the power profile reported in this study closely aligns with the result of Schmid and Borkenstein,23 who derived the power profile of the TECNIS PureSee (model ZEN00V) from the measured wavefront of the IOL. On the other hand, it is remarkable the differences with the enhanced monofocal IOL of the same company (TECNIS Eyhance IOL), whose power profile showed a monotonous (ie, without power peaks) and rapid decay from the center to the periphery of the lens.13,21 Recently, Garzon et al10 reported the power profile of a non-diffractive wavefront-shaping EDOF IOL (Acrysof IQ Vivity). Although both lenses (Acrysof IQ Vivity and TECNIS PureSee) presented the largest power variation in the central zone, the difference between their power patterns should be noted. Other EDOF and enhanced monofocal IOL designs provide an increase of the effective IOL power (myopic shift) for smaller pupils.18,24 The initial analysis of the TECNIS PureSee IOL’s power profile might also suggest such myopic shift for smaller pupils. However, as explained below, this IOL does not exhibit this behavior. This difference probably comes from the proper design of the central zone, dedicating the most central zone to the base power, which allows the IOL to work somehow as a bifocal lens for smaller pupils (2.5 to 3.5 mm). Once the power profile was measured and interpreted, the optical performance was assessed by TFMTF analysis (Figure 2). This metric was evaluated for 2-, 3-, and 4.5-mm apertures in the IOL plane, which would correspond to an eye entrance pupil of 2.3-, 3.5and 5.2-mm and might be a good representation of the patient’s pupil size from photopic to mesopic conditions. The curves of TF-MTFa (Figure 2B) revealed an association between the pupil size and the maximum optical quality and curve shape. The larger the pupil, the higher the MTFa peak and thus the optical quality at 0.00 D focus, but with a narrower monofocal-like curve shape. As the pupil decreases, the MTFa curve becomes wider, therefore increasing the depth of focus. These correlations were also found by Schmid and Borkenstein23 for the TECNIS PureSee (ZEN00V, the three-piece IOL model) IOL. Furthermore, the widening of the MTFa curve, and hence, the increase of the depth of focus as the pupil becomes smaller, have been also found with other non-diffractive EDOF designs (Lentis Comfort,24 MiniWell,24 LuxSmart,24,25 and Acrysof IQ Vivity18,19,24). In addition to the dependence of optical quality on the pupil shown above, several EDOF and enhanced monofocal IOL designs also exhibited pupil dependence in terms of its effective power, the latter typically involving a myopic shift with smaller apertures.13,18,19,24,25 Although this effect may be positive to help focusing objects at closer distances where pupillary miosis occurs naturally, it would be counterproductive when looking at distance with a relatively small pupil (eg, at the beach on a bright sunny day). In contrast, our optical-bench results with the TECNIS PureSee IOL show that for the pupil range considered (2 to 4.5 mm at the IOL plane), the best focus consistently correspond to the lens’s base power (ie, distance vision). Therefore, this analysis suggests that the effective power of the TECNIS PureSee lens is not pupil dependent, which may have a positive impact on the patient’s satisfaction because their pupil aperture will change depending on the illumination conditions. The simulated visual acuity from +1.00 to -3.00 D of defocus (Figure 3) yielded a smooth simulated defocus curve with a slight drop at the intermediate vision, reaching values better than 0.2 logMAR up to 2.00 D (equivalent to 50 cm), and showing a decrease for higher defocus values. These results can be compared to those obtained by Alarcon et al7 using the same EDOF IOL design, the latter showing a slightly better intermediate vision. Of note, the simulated visual acuity calculations were taken binocularly, whereas our study was calculated monocularly, and it does not take into account the favorable contribution of both eyes to visual acuity. These findings suggest (and it was confirmed subsequently in our clinical study discussed below) that the TECNIS PureSee IOL could meet the standard of EDOF IOL according to the American Academy of Ophthalmology Task Force Consensus for EDOF lenses.26 The last arm of the in vitro evaluation was the assessment of the halo induced by the TECNIS PureSee IOL. Interestingly and in contrast with diffractive multifocal IOLs where the higher halos were created for higher pupil sizes,27 the halo features with TECNIS PureSee, in terms of both size and energy, were smaller for larger apertures (Figure 4). For the aperture size of 4.5 mm, the halo size was small (13.2 ± 0.2 arcmin) and, therefore, less energy (0.42 ± 0.01) was wasted in the halo. This association between large pupils and small halos was also reported with another nondiffractive EDOF IOL design but only with monochromatic green light.18,19 Considering that the halo has its peak of discomfort in night and dim conditions, when the pupil size is larger, the intensity of the halo formed by an eye with the TECNIS PureSee IOL will be low. Thus, it should be expected that this IOL design provokes reduced levels of photic phenomena in patients, as has been subsequently confirmed in the clinical study. e340 Moreover, considering that postoperative refractive errors can occur after IOL implantation, it is crucial to assess the effect of defocus on the halo formed at the best image plane. Hyperopic and myopic defocus were studied for a 4.5-mm IOL aperture (5.2-mm eye’s entrance pupil, representative of night vision). Although the halo features were not significantly influenced by the defocus (Figure 5), the positive defocus (postoperative residual myopia) increased the relative energy of the halo, inducing a slight increase of halo intensity. These results agree with two previous studies7,28 that revealed that the presence of a slight amount of defocus increased the halo induced by the TECNIS PureSee IOL but in a similar way to the halo of a monofocal IOL (Tecnis One, ZCB00). Moreover, the EDOF TECNIS PureSee IOL showed a dysphotopsia profile comparable to the monofocal IOL, even in the presence of mild refractive error, and lower levels of dysphotopsia than a diffractive EDOF design (Tecnis Symfony ZXR00). These results suggest that postoperative refractive error, mainly myopic, could have an impact on photic phenomena, although visual acuity would be essentially preserved. Once the optical quality of the TECNIS PureSee IOL was assessed, it was crucial to validate these findings in a clinical setting to determine its visual performance. Our results at 3 months yielded excellent visual and refractive outcomes. The monocular UDVA and CDVA were 0.10 ± 0.15 and 0.05 ± 0.09 logMAR, respectively, and all eyes had a refractive sphere within ±0.50 D. The monocular defocus curve obtained with the TECNIS PureSee IOL showed a peak of maximum vision at 0.00 D defocus, followed by a smooth decay for both hyperopic and myopic vergences. The curve showed a good tolerance to positive defocus (postoperative myopic defocus), with a visual acuity close to 0.0 logMAR for +0.50 D and 0.1 logMAR for +1.00 D. For negative defocus (intermediate and near vision) the visual acuity was better than 0.2 logMAR (20/32) up to a vergence of -2.00 D (equivalent to 50 cm), and 0.25 ± 0.15 logMAR at the vergence -2.50 D (equivalent to 40 cm). These results showed that this new EDOF IOL provides good distance visual acuity, optimal or functional, up to a distance between 50 and 40 cm from the eye. Corbett et al8 also reported mean monocular defocus curves for the TECNIS PureSee IOL (ZEN00V). The monocular negative defocus range where visual acuity of 0.2 logMAR or better was achieved extended to -1.60 D, slightly lower than our study (-2.00 D). A recent article29 developed a functional classification of simultaneous vision IOL seeking a global consensus, where IOLs could be classified depending on the shape of the defocus curve. According to this, the TECNIS PureSee IOL analyzed in our study could be classified as an “extended” design. Finally, this study has some limitations that need to be acknowledged. We did not evaluate the patient’s subjective perception with a validated questionnaire. However, all patients were asked if they perceived disturbing halos and glare and how frequent and bothersome these visual disturbances were; only one patient reported experiencing glare occasionally and with slight intensity. Similar findings were reported by Corbett et al,8 showing high percentages of patients who did not experience, were not bothered by, or were slightly bothered by visual symptoms. Additionally, another limitation is the number of patients included and the short postoperative follow-up period. These factors should be taken into consideration in future research to provide a more comprehensive and representative evaluation of the clinical performance of the TECNIS PureSee IOL. CONCLUSION The TECNIS PureSee IOL provided good distance optical and visual quality, and a clinically determined extended depth of field of approximately 2.00 D. The optical performance was pupil dependent in terms of maximum quality MTFa peak (achieved for 0.00 D) and MTFa curve width, increasing the depth of focus for smaller pupils. However, the lens design does not exhibit the myopic power shift commonly found with small apertures in other EDOF IOLs available in the market. The halo induced by the lens in mesopic condition was of low size and energy. A small amount of refractive error could be well tolerated but could also slightly increase the halo. AUTHOR CONTRIBUTIONS Study concept and design (BA-B, IM-A, LF-V-C, FV, MSM, DM-C, JFA); data collection (BA-B, IM-A, FC); analysis and interpretation of data (BA-B, IM-A, LF-V-C, FC, FV, MSM, DM-C, JFA); writing the manuscript (BA-B, IM-A); critical revision of the manuscript (LF-V-C, FC, FV, MSM, DM-C, JFA); supervision (DM-C, JFA) REFERENCES 1. Cao K, Friedman DS, Jin S, et al. 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