Journal of Refractive Surgery

Original Article Supplemental Data

Visual Performance With Bifocal and Trifocal Diffractive Intraocular Lenses: A Prospective Three-Armed Randomized Multicenter Clinical Trial

Hakan Kaymak, MD; Detlev Breyer, MD; Jorge L. Alió, MD, PhD, FEBO; Beatrice Cochener, MD, PhD

Abstract

PURPOSE:

To evaluate and compare quality of vision and reading performance outcomes after implantation of bifocal refractive-diffractive, bifocal apodized diffractive, or trifocal diffractive-refractive intraocular lenses (IOLs).

METHODS:

This randomized, prospective, three-armed multicenter (Spain, Germany, and France) trial included 104 eyes of 52 patients (mean age: 63.2 ± 7.7 years). Patients underwent cataract surgery with bilateral implantation of either AT LISA 809M (Carl Zeiss Meditec, Jena, Germany: AT LISA group, 38 eyes), AT LISA tri 839MP (Carl Zeiss Meditec: AT LISA tri group, 32 eyes), or ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX: ReSTOR group, 34 eyes) IOLs. Visual and refractive outcomes, depth of focus, and reading performance were evaluated at 1, 6, and 12 months postoperatively.

RESULTS:

The AT LISA tri group showed significantly better 12-month uncorrected (UIVA) and binocular distance-corrected (DCIVA) intermediate visual acuity (P ≤ .016) than the AT LISA group. The AT LISA tri group showed a significantly better 3-month UIVA compared to the ReSTOR group (P = .042). Binocular uncorrected and corrected distance visual acuities were not significantly different among groups (P ≥ .092) at the 12-month follow-up. A total of 85.3%, 90.0%, and 78.1% of eyes had a spherical equivalent within ±0.50 D in the AT LISA, AT LISA tri, and ReSTOR groups, respectively, at 12 months (P = .038). No statistically significant differences between the trifocal and bifocal groups were detected for reading performance (P ≥ .055).

CONCLUSIONS:

The trifocal diffractive-refractive IOL provides enhanced intermediate visual restoration compared to bifocal diffractive-refractive or apodized diffractive IOLs. The addition of an intermediate focal point did not deteriorate far or near vision. A comparable reading performance was maintained with the trifocal lens.

[J Refract Surg. 2017;33(10):655–662.]

Abstract

PURPOSE:

To evaluate and compare quality of vision and reading performance outcomes after implantation of bifocal refractive-diffractive, bifocal apodized diffractive, or trifocal diffractive-refractive intraocular lenses (IOLs).

METHODS:

This randomized, prospective, three-armed multicenter (Spain, Germany, and France) trial included 104 eyes of 52 patients (mean age: 63.2 ± 7.7 years). Patients underwent cataract surgery with bilateral implantation of either AT LISA 809M (Carl Zeiss Meditec, Jena, Germany: AT LISA group, 38 eyes), AT LISA tri 839MP (Carl Zeiss Meditec: AT LISA tri group, 32 eyes), or ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX: ReSTOR group, 34 eyes) IOLs. Visual and refractive outcomes, depth of focus, and reading performance were evaluated at 1, 6, and 12 months postoperatively.

RESULTS:

The AT LISA tri group showed significantly better 12-month uncorrected (UIVA) and binocular distance-corrected (DCIVA) intermediate visual acuity (P ≤ .016) than the AT LISA group. The AT LISA tri group showed a significantly better 3-month UIVA compared to the ReSTOR group (P = .042). Binocular uncorrected and corrected distance visual acuities were not significantly different among groups (P ≥ .092) at the 12-month follow-up. A total of 85.3%, 90.0%, and 78.1% of eyes had a spherical equivalent within ±0.50 D in the AT LISA, AT LISA tri, and ReSTOR groups, respectively, at 12 months (P = .038). No statistically significant differences between the trifocal and bifocal groups were detected for reading performance (P ≥ .055).

CONCLUSIONS:

The trifocal diffractive-refractive IOL provides enhanced intermediate visual restoration compared to bifocal diffractive-refractive or apodized diffractive IOLs. The addition of an intermediate focal point did not deteriorate far or near vision. A comparable reading performance was maintained with the trifocal lens.

[J Refract Surg. 2017;33(10):655–662.]

Multifocal intraocular lens (IOL) designs were initially bifocal and were developed to improve uncorrected near visual acuity and to reduce spectacle dependence at near distance.1–3 More recently, trifocal technology was developed to overcome the limitation of visual function at intermediate distance, an important factor in patient satisfaction outcomes, in particular due to extended computer use and higher patient expectations. Trifocal diffractive-refractive IOLs were developed to provide optimized visual acuity for intermediate distance.4–8 Several comparative studies have been conducted to compare the clinical outcomes obtained with different types of multifocal IOLs to define more consistent criteria for the selection of one particular model of IOL for each specific case.4–8 Several authors4,8–11 have evaluated visual outcomes and patient satisfaction in a 3- or 6-month follow-up of the trifocal AT LISA tri 839MP (Carl Zeiss Meditec, Jena, Germany). However, the impact of a third focal point on visual acuity and reading performance at three distinct intermediate distances and at 12 months postoperatively is not known. The three-armed multicenter randomized clinical trial described in this study provides, for the first time, comparisons on visual and refractive outcomes, depth of focus, and reading performances after implantation of a bifocal diffractive-refractive IOL, a bifocal apodized diffractive IOL, or a trifocal diffractive-refractive IOL.

Patients and Methods

A total of 104 eyes of 52 patients were enrolled in three different ophthalmological centers (Dr. med. Hakan Kaymak Breyer Augenchirurgie, Dusseldorf, Germany, Prof. Béatrice Cochener Hôpital Morvan, Brest, France, and Professor Jorge Alió Vissum Instituto, Alicante, Spain). All patients underwent uneventful phacoemulsification surgery with bilateral implantation of a multifocal IOL. Patients were randomly assigned to one of the three multifocal IOL groups (Table A, available in the online version of this article and Table 1): the AT LISA group, in which the bifocal diffractive-refractive IOL AT LISA 809M (Carl Zeiss Meditec) was implanted, the AT LISA tri group, in which the trifocal diffractiverefractive IOL AT LISA tri 839MP was implanted, and the ReSTOR group, in which the apodized diffractive IOL ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) was implanted. The randomization code was administered centrally using a vocal server and allocated to the patient in the chronological order of the surgery. All patients were unaware of the implanted lens type and an independent observer performed the postoperative measurements in each center.

Main Characteristics of the IOLs Implanted

Table A:

Main Characteristics of the IOLs Implanted

Main Preoperative Characteristics of the Sample Evaluateda

Table 1:

Main Preoperative Characteristics of the Sample Evaluated

Inclusion criteria for the study were patients with cataract (aged 50 to 80 years) seeking spectacle independence and with preexisting refractive corneal astigmatism of less than 1.00 diopters (D). Exclusion criteria were degenerative visual disorders that permanently limit the corrected distance visual acuity (CDVA) to 0.3 logMAR (Snellen 20/40) or worse, glaucoma and/or intraocular pressure (IOP) greater than 24 mm Hg, intraoperative complications, and any other at-risk pathology. All patients were adequately informed about the study and signed a consent form before surgery. The study adhered to the tenets of the Declaration of Helsinki and the ethics committee of each participating center approved it.

Examination Protocol

Before surgery, a complete ophthalmological examination was performed. Postoperatively, patients were evaluated 1, 3, 6, and 12 months after surgery. Measurement of monocular and binocular uncorrected distance visual acuity (UDVA) and CDVA; measurement of binocular uncorrected intermediate vision acuity (UIVA) and distance corrected intermediate visual acuity (DCIVA) at 70, 80, and 90 cm (Early Treatment of Diabetic Retinopathy Study [ETDRS] charts, Precision Vision, Woodstock, IL); and measurement of binocular uncorrected near vision acuity (UNVA) and distance corrected near visual acuity (DCNVA) at 40 cm and manifest refraction were done under photopic conditions (minimum 85 cd/m2). Analysis of binocular reading performance with the Radner Reading Charts at 40 cm was performed at 3 and 12 months postoperatively. Defocus curves were measured at 3 and 12 months after surgery. Patients wore the correction providing the best distance visual acuity in both eyes and the ETDRS charts were used at a distance of 4 m. Different levels of defocus were introduced in 0.50-diopter (D) steps from +1.00 to −4.00 D and visual acuity values were then recorded. Data were represented in a Cartesian graphic display.

Surgical Procedure

All surgeries were performed under topical anesthesia by one of the four experienced surgeons (JLA, DB, HK, and BC) using sutureless microincision phacoemulsification and an incision size of 2.2 mm or less. The IOLs were implanted using the specific injector.

Statistical Analysis

Statistical analyses were computed with SAS software (version 9.3; SAS Institute, Inc., Cary, NC). Parameters were summarized by treatment group and overall using quantitative parameters in terms of mean, standard deviation, median, and extreme values (minimum and maximum), and qualitative parameters in terms of number and percentage of each modality. Comparisons between treatment groups were performed using one-way analysis of variance with Bonferroni post-hoc analysis for quantitative parameters that followed a normal distribution (Kolmogorov–Smirnov test), Kruskal–Wallis test for quantitative parameters that did not follow a normal distribution (Kolmogorov–Smirnov test), chi-square test for qualitative parameters, and Cochran–Mantel–Haenszel test for ordinal parameters.

Results

A total of 104 eyes of 52 patients with a mean age of 63.2 ± 7.7 years (range: 48 to 78 years) were enrolled. Three groups were differentiated according to the type of multifocal IOL implanted: AT LISA group (38 eyes, 19 patients), AT LISA tri group (32 eyes, 16 patients), and ReSTOR group (34 eyes, 17 patients). Three patients withdrew prematurely after surgery, resulting in the following final proportion of patients per treatment group: AT LISA group (34 eyes, 17 patients), AT LISA tri group (30 eyes, 15 patients), and ReSTOR group (34 eyes, 17 patients). Table 1 summarizes the main pre-operative characteristics of the sample evaluated. As shown, only statistically significant differences among groups were found preoperatively in axial length (P = .013). However, no statistically significant differences were found in the power of the IOL implanted (P = .504).

Visual Acuity Outcomes

Tables BD (available in the online version of this article) summarize and compare the postoperative binocular intermediate visual outcomes during the 1-, 3-, 6-, and 12-month follow-up times and at 70, 80, and 90 cm distances for the bifocal and trifocal groups. Three intermediate distances were chosen to cover the various lifestyle priorities of patients (cooking or computer use, mobile phone, or book reading) that use different intermediate focus distances. Better UIVA and DCIVA were obtained for the AT LISA tri group compared to the AT LISA group at 80 and 90 cm at 1 and 3 months. The AT LISA tri group demonstrated significantly better DCIVA compared to the ReSTOR group at 3 months postoperatively and at 80 (P = .011) and 90 (P = .013) cm. Figure 1 provides an overall picture of the refractive outcomes of the three IOLs 12 months postoperatively. Figures 1A–1B demonstrate the efficacy of the IOLs, comparing UDVA with CDVA. Figure 1C demonstrates the predictability of refractive outcomes and the distribution of manifest refraction is given in Figure 1D. Figure 2 summarizes the distribution of binocular intermediate visual acuity data, UIVA, and DCIVA at 12-months at the three distances measured in this study. A total of 24%, 53%, and 56% of eyes achieved binocular UIVA of 0.1 logMAR (Snellen 20/25) or better for the AT LISA (809M), AT LISA tri (839MP), and ReSTOR (SNA6D1) groups, respectively, at 70 cm distance. This percentage increased for all groups at 80 cm (809M, 59%; 839MP, 73%; SNA6D1, 63%). When measurements were taken at 90 cm, 53% of the AT LISA tri group achieved binocular UIVA of 20/25 or better, the same percentage as at 70 cm. The value increased to 53% for the AT LISA group. In the RESTOR group, 38% achieved binocular UIVA of 20/25 or better compared to 56% at 70 cm. The study shows that, overall, patient outcomes were satisfactory over the three intermediate distances measured in the AT LISA tri group.

Postoperative Binocular Intermediate Visual Outcomes at 70 cma

Table B:

Postoperative Binocular Intermediate Visual Outcomes at 70 cm

Postoperative Binocular Intermediate Visual Outcomes at 80 cma

Table C:

Postoperative Binocular Intermediate Visual Outcomes at 80 cm

Postoperative Binocular Intermediate Visual Outcomes at 90 cma

Table D:

Postoperative Binocular Intermediate Visual Outcomes at 90 cm

Twelve-month refractive outcomes following cataract surgery in three patient groups implanted with the bifocal AT LISA 809M, trifocal AT LISA 839MP (Carl Zeiss Meditec, Jena, Germany), or ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) intraocular lens. (A) Uncorrected distance visual acuity (UDVA). (B) UDVA versus corrected distance visual acuity (CDVA). (C) Spherical equivalent refractive accuracy in diopters (D). (D) Refractive cylinder values (D).

Figure 1.

Twelve-month refractive outcomes following cataract surgery in three patient groups implanted with the bifocal AT LISA 809M, trifocal AT LISA 839MP (Carl Zeiss Meditec, Jena, Germany), or ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) intraocular lens. (A) Uncorrected distance visual acuity (UDVA). (B) UDVA versus corrected distance visual acuity (CDVA). (C) Spherical equivalent refractive accuracy in diopters (D). (D) Refractive cylinder values (D).

Twelve-month binocular intermediate visual acuity outcomes for patient groups implanted with the bifocal AT LISA 809M, trifocal AT LISA 839MP (Carl Zeiss Meditec, Jena, Germany), or bifocal ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) intraocular lens measured at 70, 80, and 90 cm distances. UIVA = uncorrected intermediate visual acuity; DCIVA = distance-corrected intermediate visual acuity

Figure 2.

Twelve-month binocular intermediate visual acuity outcomes for patient groups implanted with the bifocal AT LISA 809M, trifocal AT LISA 839MP (Carl Zeiss Meditec, Jena, Germany), or bifocal ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) intraocular lens measured at 70, 80, and 90 cm distances. UIVA = uncorrected intermediate visual acuity; DCIVA = distance-corrected intermediate visual acuity

Tables EF (available in the online version of this article) summarize the postoperative binocular near and distance visual outcomes at 1, 3, 6, and 12 months, respectively. Concerning near vision, statistically significant differences among groups were only found in 3-month postoperative DCNVA (P = .044). Specifically, DCNVA was significantly better in the ReSTOR group compared to the AT LISA group (P = .0023). No significant differences among groups in postoperative binocular UDVA and CDVA were detected during the whole follow-up (P ≥ .233).

Postoperative Binocular Near Visual Outcomes at 40 cma

Table E:

Postoperative Binocular Near Visual Outcomes at 40 cm

Postoperative Binocular Distance Visual Outcomesa

Table F:

Postoperative Binocular Distance Visual Outcomes

Regarding the stability of the visual outcomes, no significant changes were detected during the postoperative follow-up in any of the three groups for the following parameters (from 1 to 12 months after surgery): UDVA (P ≥ .389), CDVA (P ≥ .252), UIVA at 70 cm (P ≥ .423), DCIVA at 70 cm (P ≥ .074), UIVA at 80 cm (P ≥ .164), DCIVA at 80 cm (P ≥ .254), UIVA at 90 cm (P ≥ .474), DCIVA at 90 cm (P ≥ .516), UNVA (P ≥ .055), and DCNVA P ≥ .656).

Refractive Outcomes

Measurements of the spherical equivalent show significant differences among groups at 3 (P = .011), 6 (P = .049), and 12 (P = .017) months after surgery. Specifically, the spherical equivalent in the ReSTOR group was significantly more myopic than in the AT LISA group (3 months: P = .009, 6 months: P = .022, 12 months: P = .004). Furthermore, 3 months postoperatively, the spherical equivalent in the AT LISA group was found to be significantly higher than in the AT LISA tri group (P = .012).

Figure 3 shows the distribution of the postoperative spherical equivalent in the three groups of eyes of the current study at 1, 3, 6, and 12 months. At 12 months after surgery (Figure 1C and Figure 3), a total of 85.3%, 90.0%, and 78.1% of eyes had a spherical equivalent within ±0.50 D in the AT LISA (range: −0.50 to 1.13 D), AT LISA tri (range: −0.50 to 1.25 D), and ReSTOR (range: −1.00 to 0.75 D) groups, respectively; the difference in benchmark value for the RESTOR group is statistically significant (P = .038). In this study, emmetropia was targeted. However, taking into account the slight myopic error found postoperatively in the ReSTOR group, this might result in the RESTOR group moving the near focus point (+3.00 D) closer to the near focus points of the AT LISA (+ 3.75 D) and AT LISA tri (+3.33 D) groups. This could explain why, in contrast to the CDVA, no significant difference in UNVA performance was found. No significant differences in the percentage of eyes within ±0.50 D were found in the remaining follow-up period (1 month: P = .224, 3 months: P = .276, 6 months: P = .112). The difference between targeted and achieved spherical equivalent correction at 12 months after surgery was 0.40 ± 0.27, 0.29 ± 0.37, and 0.29 ± 0.23 D in the AT LISA, AT LISA tri, and ReSTOR groups, respectively (P = .228).

Distribution of the spherical equivalent in the AT LISA, AT LISA tri (Carl Zeiss Meditec, Jena, Germany), and ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) groups at four time points during the 12-month postoperative follow-up. D = diopters

Figure 3.

Distribution of the spherical equivalent in the AT LISA, AT LISA tri (Carl Zeiss Meditec, Jena, Germany), and ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) groups at four time points during the 12-month postoperative follow-up. D = diopters

Defocus Curves

Figure 4 displays the mean defocus curves obtained in the three groups 3 and 12 months postoperatively. At 3 months, the binocular visual acuities measured with different defocus lenses were not statistically significantly different between the treatment groups (P ≥ .075), except with the defocus lens of −1.00 D (P = .006), where the visual acuity obtained with the AT LISA tri group was significantly better than in the ReSTOR group (P = .002). At 12 months, significant differences among groups were found in the binocular visual acuities measured with defocus lenses of −2.00 D (P = .002), −1.50 D (P = .026), −1.00 D (P = .019), −0.50 D (P = .021), 0.00 D (P = .005), and 0.50 D (P = .010). Specifically, the visual acuity obtained in the AT LISA bifocal group was significantly less than for the two other groups, with defocus lenses of −2.00, −1.50, 0.00, and 0.50 D (P ≤ .045). On the other hand, the AT LISA tri group showed significantly better visual acuity than the ReSTOR group with the defocus lenses of −0.50 (P = .044) and −1.00 D (P = .002).

Mean binocular defocus curves for the AT LISA, AT LISA tri (Carl Zeiss Meditec, Jena, Germany), and ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) groups at 3 (top) and 12 (bottom) months postoperatively. D = diopters; VA = visual acuity

Figure 4.

Mean binocular defocus curves for the AT LISA, AT LISA tri (Carl Zeiss Meditec, Jena, Germany), and ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX) groups at 3 (top) and 12 (bottom) months postoperatively. D = diopters; VA = visual acuity

Reading Performance

Reading acuity at preferred distance (ie, most comfortable distance for reading) was calculated using the Radner Reading Charts and taking note of reading errors in words of different lengths (Table 2). They were comparable between the three groups at 3 and 12 months after surgery (P = .344 and .302, respectively). Distance corrected maximum reading speed was also similar between groups at 3 and 12 months postoperatively (P = .994 and .837, respectively). Likewise, there were no statistically significant differences between groups in corrected reading speed at 0.4 logRAD (P = .434 and .727 at 3 and 12 months, respectively) and distance corrected critical print size (P = .074 and .055 at 3 and 12 months, respectively).

Postoperative Reading Performance Outcomesa

Table 2:

Postoperative Reading Performance Outcomes

Complications

At the end of the follow-up, mild temporal IOL decentration was observed in 1 eye of the ReSTOR group. This individual case (2.9%) influences to a limited extent the overall outcomes on visual acuity for the ReSTOR group. Statistical analysis was performed on the population for whom at least one postoperative measurement of the main endpoint was available. For this reason, the patient could not be excluded.

Discussion

The three IOLs evaluated in our randomized three-armed study showed differences in intermediate vision, with an overall better outcome with the trifocal IOL. The three different intermediate vision distances measured reflect the importance of intermediate vision tasks for good patient outcomes. The different distances are highly relevant for tasks such as reading on a mobile phone, working on a computer, or cooking, which usually vary within 70 to 90 cm. The data presented here are in accordance with the results of previous studies using an optical bench12,14 and are consistent with the results obtained by Mojzis et al.4 comparing the clinical outcomes obtained with the AT LISA bifocal and trifocal diffractive IOLs. In our study, 1- and 3-month postoperative binocular UIVA, 3-month DCIVA measured at 80 cm, and 3-month binocular UIVA and DCIVA measured at 90 cm were significantly better in eyes implanted with the trifocal IOL compared to the bifocal group. Likewise, postoperative binocular UIVA, measured at 80 cm, was significantly better in the AT LISA tri group compared to the ReSTOR group at 3 months postoperatively. This is consistent with the outcomes obtained in optical bench tests comparing ReSTOR and AT LISA tri IOLs.15 The improved outcome with the AT LISA trifocal IOL, compared to the bifocal diffractive-refractive and the apodized diffractive IOLs, was also observed 6 and 12 months after surgery, but the differences were not statistically significant. This may be due to the increase in the variability of the outcomes at the end of the follow-up period, with some isolated cases resulting in a worsening of the visual acuity, possibly due to the presence of posterior capsule opacification and the temporal decentration observed. However, we checked each affected patient to look at the effect of posterior capsule opacification on visual acuity results and found that in one case only (2.9%) posterior capsule opacification was clinically significant at 6 months in the AT LISA group.

Regarding near vision, statistically significant differences were found in our study for binocular DCNVA at 3 months: postoperative values were significantly better in the ReSTOR group compared to the AT LISA group. However, no significant differences in UNVA were found between IOL groups during the remaining follow-up and mean values were close to 0.10 logMAR (Snellen 20/25). The comparative analysis of Mojzis et al.4 between the AT LISA bifocal and trifocal IOLs showed better monocular UNVA and DCNVA measured at 33 and 40 cm in the trifocal group compared to the bifocal group. In another comparative analysis, Alió et al.8 found significantly better monocular UNVA and DCNVA with the AT LISA bifocal IOL compared to the ReSTOR IOL. In contrast, no significant differences were found in binocular near visual acuity when AT LISA bifocal and ReSTOR IOLs were compared.15,16

Concerning distance vision, no significant differences in binocular UDVA were found among groups in our study. Likewise, no significant differences between IOL groups were found in postoperative binocular CDVA, clinically indicating a similar level of visual quality for the three IOLs under evaluation. Alfonso et al.15 compared the clinical outcomes obtained in eyes implanted with the same type of apodized IOL but with a higher add (ReSTOR SN6AD3) and in eyes implanted with the AT LISA bifocal diffractive-refractive IOL, and found that the two diffractive aspheric IOL models gave similar visual acuity at far and near distances.

The visual acuity results obtained in our study were confirmed with the comparative analysis of the defocus curves. Significantly, better visual acuities were obtained 3 and 12 months after surgery with the trifocal IOL compared to the bifocal and apodized IOLs for defocus lenses simulating intermediate vision. Mojzis et al.4 also found significant differences among IOLs in the visual acuity obtained for the defocus levels of −0.50 to −1.50 D (P ≤ .04). Binocular defocus curves obtained in our study were consistent with those reported by previous authors for the same type of IOLs,2,11,17–20 with a significantly better area of intermediate vision for the trifocal AT LISA tri IOL. The good visual outcomes obtained in the three groups of our randomized study were consistent with a high predictability of the refractive correction. Postoperative manifest sphere and cylinder were close to zero in all three groups, with a significantly more hyperopic postoperative sphere and spherical equivalent with the trifocal diffractiverefractive IOL and a more myopic postoperative sphere and spherical equivalent for the ReSTOR group. This could explain the significant difference observed in postoperative monocular UDVA when the ReSTOR and AT LISA IOLs were compared. At 12 months postoperatively, fewer eyes had a spherical equivalent within ±0.50 D in the ReSTOR group compared to the AT LISA and AT LISA tri groups. Several factors may contribute to this finding, such as differences in the IOL power calculation procedures or changes in IOL position and biometry. Moreno et al.20 demonstrated in a case series that the apodized IOL used in our study was able to restore the distance and near visual function, but the IOL power was a limiting factor for the final visual outcomes and for optical quality.

Reading performance is an important aspect of postoperative patient expectation. In this study, it was evaluated using the Radner Reading Charts, as described in previous comparative studies of different types of IOL.10,21 We evaluated distance corrected reading acuity, distance corrected maximum reading speed, and distance corrected critical print size at 3 and 12 months (Table 2). The impact on reading acuity and speed was similar for all patients, regardless of the type of IOL implanted. No statistical significance was found between groups. Rasp et al.21 measured uncorrected reading acuity and uncorrected smallest print size in eyes implanted with diffractive bifocal IOLs and found that they were similar or significantly better than in eyes implanted with monofocal and refractive multifocal IOLs.21 Alió et al.8 compared the bilateral reading performance within the first 6 months after implantation of one monofocal and three multifocal IOLs. Bifocal IOLs achieved significantly better uncorrected reading acuity compared to monofocal and refractive multifocal IOLs (P < .01). However, it should be noted that reading is a complex process that involves not only vision, but also other variables such as attention span and cognitive skills.22

In this three-armed randomized multicenter study, the level of intermediate visual acuity provided by the trifocal diffractive-refractive AT LISA tri IOL evaluated was generally better compared to the bifocal diffractive-refractive and apodized refractive IOLs, with comparable distance and near visual outcomes. Therefore, near and distance visual performance is not degraded by the addition of a third focal point. The effective near visual restoration achieved with the three IOLs evaluated provides a satisfactory reading performance and no clinically relevant differences in patients implanted with either bifocal lens or the trifocal lens were found in reading performance.

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  17. Alfonso JF, Fernández-Vega L, Puchades C, Montés-Micó R. Intermediate visual function with different multifocal intraocular lens models. J Cataract Refract Surg. 2010;36:733–739. doi:10.1016/j.jcrs.2009.11.018 [CrossRef]
  18. Kohnen T, Titke C, Böhm M. Trifocal intraocular lens implantation to treat visual demands in various distances following lens removal. Am J Ophthalmol. 2016;161:71–77. doi:10.1016/j.ajo.2015.09.030 [CrossRef]
  19. Mojzis P, Majerova K, Hrckova L, Piñero DP. Implantation of a diffractive trifocal intraocular lens: one-year follow-up. J Cataract Refract Surg. 2015;41:1623–1630. doi:10.1016/j.jcrs.2014.11.050 [CrossRef]
  20. Moreno LJ, Piñero DP, Alió JL, Fimia A, Plaza AB. Double-pass system analysis of the visual outcomes and optical performance of an apodized diffractive multifocal intraocular lens. J Cataract Refract Surg. 2010;36:2048–2055. doi:10.1016/j.jcrs.2010.07.021 [CrossRef]
  21. Rasp M, Bachernegg A, Seyeddain O, et al. Bilateral reading performance of 4 multifocal intraocular lens models and a monofocal intraocular lens under bright lighting conditions. J Cataract Refract Surg. 2012;38:1950–1961. doi:10.1016/j.jcrs.2012.07.027 [CrossRef]
  22. Montés-Micó R, Alió JL. Near vision evaluation considering reading performance. J Refract Surg. 2006;22:15–16.

Main Preoperative Characteristics of the Sample Evaluateda

ParameterAT LISA Group (n = 38)AT LISA tri Group (n = 32)ReSTOR Group (n = 34)P
Age (y)64.4 ± 7.562.5 ± 6.962.4 ± 8.9.698
Gender (male)8 (42.1%)4 (25.0%)9 (52.9%).258
CDVA (logMAR)0.12 ± 0.290.06 ± 0.150.12 ± 0.13.422
DCNVA (logMAR)0.66 ± 0.320.66 ± 0.330.60 ± 0.28.418
Sphere (D)+1.33 ± 1.60+1.10 ± 1.76+1.05 ± 1.38.730
Cylinder (D)−0.49 ± 0.43−0.41 ± 0.36−0.48 ± 0.52.717
SE (D)+1.09 ± 1.68+0.90 ± 1.72+0.81 ± 1.45.765
IOP (mm Hg)15.1 ± 2.014.4 ± 2.215.2 ± 2.5.393
AL (mm)22.99 ± 0.6423.40 ± 0.8823.58 ± 0.81.013
IOL power (D)21.5 ± 1.821.8 ± 2.221.4 ± 1.4.504

Postoperative Reading Performance Outcomesa

ParameterAT LISA GroupAT LISA tri GroupReSTOR GroupP
Month 3N = 17N = 13N = 16
  Distance corrected reading acuity (logRAD)0.11 (0.15) 0.10 (−0.10 to 0.34)0.14 (0.09) 0.11 (0.015 to 0.35)0.07 (0.09) 0.08 (−0.10 to 0.265).344
  Distance corrected maximum reading speed (wpm)190.63 (49.65) 191.00 (58 to 263)200.00 (48.40) 183.00 (149 to 342)191.69 (49.68) 199.50 (60 to 263).994
  Distance corrected reading acuity at logRAD 0.4150.25 (58.75) 146.00 (31 to 263)158.69 (24.94) 165.00 (111 to 187)172.06 (48.91) 176.50 (87 to 255).434
  Distance corrected critical print size (logRAD)0.25 (0.20) 0.20 (−0.10 to 0.60)0.28 (0.10) 0.30 (0.10 to 0.405)0.16 (0.08) 0.20 (0.00 to 0.305).074
Month 12N = 16N = 15N = 16
  Distance corrected reading acuity (logRAD)0.10 (0.17) 0.02 (−0.10 to 0.465)0.12 (0.13) 0.06 (0.00 to 0.455)0.05 (0.11) 0.03 (−0.10 to 0.36).302
  Distance corrected maximum reading speed (wpm)199.75 (40.75) 202.50 (120 to 271)202.00 (28.71) 202.00 (145 to 271)194.88 (31.03) 200.50 (129 to 249).837
  Distance corrected reading acuity at logRAD 0.4159.13 (60.51) 164.50 (32 to 271)150.00 (29.24) 156.00 (100 to 195)162.63 (38.69) 164.50 (82 to 215).727
  Distance corrected critical print size (logRAD)0.23 (0.19) 0.20 (−0.10 to 0.605)0.25 (0.10) 0.21 (0.10 to 0.50)0.17 (0.17) 0.10 (0.00 to 0.61).055

Main Characteristics of the IOLs Implanted

ParameterAT LISA 809MAT LISA tri 839MPAcrysof ReSTOR SN6AD1
MaterialHydrophilic acrylic (25%) with hydrophobic surfaceHydrophilic acrylic (25%) with hydrophobic surfaceHydrophobic acrylic
Optic diameter (mm)666
Total diameter (mm)111113
Haptic angulation
Lens designSingle-pieceSingle-pieceSingle-piece
Recommended incision size (mm)1.81.82.2
Company labeled A-constant117.8118.6118.9
Addition (D)+3.75+3.33 near, +1.66 intermediate+3.00
Diopter rangeFrom 0.00 to +32.00 D (0.50-D increments)From 0.00 to +32.00 D (0.50-D increments)From +6.00 to +34.00 D (0.50-D increments)

Postoperative Binocular Intermediate Visual Outcomes at 70 cma

ParameterAT LISA GroupAT LISA tri GroupReSTOR GroupComparisonP
Month 1171517
  UIVA (logMAR)0.22 (0.20); 0.25 (−0.04 to 0.46)0.12 (0.16); 0.06 (−0.28 to 0.46)0.20 (0.20); 0.16 (−0.04 to 0.56)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.247; .234; .697
  DCIVA (logMAR)0.21 (0.17); 0.25 (−0.04 to 0.46)0.12 (0.17); 0.06 (−0.28 to 0.46)0.14 (0.16); 0.16 (−0.04 to 0.46)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.171; .807; .345
Month 3171517
  UIVA (logMAR)0.22 (0.21); 0.16 (−0.04 to 0.76)0.10 (0.17); 0.06 (−0.18 to 0.56)0.15 (0.15); 0.16 (−0.04 to 0.46)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.087; .352; .400
  DCIVA (logMAR)0.21 (0.19); 0.16 (−0.04 to 0.76)0.09 (0.16); 0.06 (−0.18 to 0.56)0.17 (0.20); 0.16 (−0.04 to 0.56)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.022; .472; .378
Month 6171517
  UIVA (logMAR)0.24 (0.21); 0.16 (−0.04 to 0.76)0.14 (0.16); 0.16 (−0.04 to 0.56)0.18 (0.17); 0.16 (−0.04 to 0.46)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.248; .620; .428
  DCIVA (logMAR)0.22 (0.21); 0.16 (−0.04 to 0.76)0.14 (0.16); 0.06 (−0.04 to 0.56)0.17 (0.13); 0.16 (−0.04 to 0.46)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.178; .361; .537
Month 12171516
  UIVA (logMAR)0.25 (0.20); 0.16 (0.06 to 0.76)0.12 (0.12); 0.06 (−0.04 to 0.46)0.15 (0.20); 0.11 (−0.24 to 0.46)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.041; .075; .936
  DCIVA (logMAR)0.23 (0.18); 0.16 (0.06 to 0.68)0.11 (0.17); 0.06 (−0.24 to 0.56)0.10 (0.19); 0.06 (−0.24 to 0.46)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.026; .180; .715

Postoperative Binocular Intermediate Visual Outcomes at 80 cma

ParameterAT LISA GroupAT LISA tri GroupReSTOR GroupComparisonP
Month 1171517
  UIVA (logMAR)0.22 (0.18); 0.19 (0.00 to 0.62)0.07 (0.16); 0.10 (−0.30 to 0.40)0.15 (0.13); 0.10 (0.00 to 0.40)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.016; .224; .123
  DCIVA (logMAR)0.21 (0.18); 0.19 (0.00 to 0.62)0.07 (0.16); 0.10 (−0.30 to 0.40)0.18 (0.20); 0.10 (−0.10 to 0.50)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.021; .581; .090
Month 3171517
  UIVA (logMAR)0.25 (0.19); 0.19 (0.00 to 0.70)0.06 (0.18); 0.00 (−0.30 to 0.50)0.20 (0.17); 0.19 (0.00 to 0.50)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.006; .042; .179
  DCIVA (logMAR)0.24 (0.19); 0.19 (0.00 to 0.70)0.05 (0.17); 0.00 (−0.30 to 0.50)0.13 (0.13); 0.10 (−0.08 to 0.40)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.002; .518; .011
Month 6171517
  UIVA (logMAR)0.19 (0.19); 0.10 (−0.10 to 0.70)0.11 (0.14); 0.10 (−0.10 to 0.50)0.16 (0.18); 0.19 (−0.10 to 0.50)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.189; .341; .638
  DCIVA (logMAR)0.19 (0.18); 0.19 (−0.10 to 0.70)0.10 (0.14); 0.10 (−0.10 to 0.50)0.12 (0.12); 0.10 (−0.10 to 0.40)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.095; .510; .436
Month 12171516
  UIVA (logMAR)0.20 (0.20); 0.10 (0.00 to 0.70)0.10 (0.11); 0.10 (0.00 to 0.40)0.17 (0.20); 0.10 (−0.20 to 0.62)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.117; .325; .569
  DCIVA (logMAR)0.19 (0.19); 0.10 (0.00 to 0.62)0.07 (0.17); 0.10 (−0.40 to 0.40)0.09 (0.17); 0.10 (−0.30 to 0.30)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.165; .823; .253

Postoperative Binocular Intermediate Visual Outcomes at 90 cma

ParameterAT LISA GroupAT LISA tri GroupReSTOR GroupComparisonP
Month 1171517
  UIVA (logMAR)0.20 (0.20); 0.14 (−0.05 to 0.65)0.06 (0.18); 0.05 (−0.39 to 0.45)0.14 (0.13); 0.14 (−0.05 to 0.45)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.070; .503; .096
  DCIVA (logMAR)0.18 (0.18); 0.14 (−0.05 to 0.65)0.05 (0.16); 0.05 (−0.39 to 0.35)0.16 (0.22); 0.11 (−0.15 to 0.57)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.067; .765; .214
Month 3171517
  UIVA (logMAR)0.23 (0.16); 0.25 (0.05 to 0.65)0.03 (0.20); −0.05 (−0.40 to 0.45)0.13 (0.13); 0.14 (−0.05 to 0.35)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.003; .058; .051
  DCIVA (logMAR)0.22 (0.18); 0.14 (−0.04 to 0.65)0.02 (0.18); −0.05 (−0.40 to 0.45)0.16 (0.15); 0.14 (−0.05 to 0.45)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.002; .342; .013
Month 6171517
  UIVA (logMAR)0.18 (0.19); 0.14 (−0.15 to 0.65)0.08 (0.14); 0.05 (−0.15 to 0.45)0.14 (0.16); 0.14 (−0.05 to 0.45)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.081; .146; .372
  DCIVA (logMAR)0.18 (0.18); 0.14 (−0.15 to 0.65)0.07 (0.14); 0.05 (−0.15 to 0.45)0.10 (0.10); 0.05 (−0.05 to 0.35)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.040; .441; .237
Month 12171516
  UIVA (logMAR)0.19 (0.21); 0.05 (−0.05 to 0.65)0.07 (0.11); 0.05 (−0.05 to 0.35)0.19 (0.15); 0.16 (−0.05 to 0.57)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.168; .853; .182
  DCIVA (logMAR)0.18 (0.20); 0.05 (−0.05 to 0.65)0.05 (0.18); 0.05 (−0.45 to 0.35)0.12 (0.15); 0.14 (−0.30 to 0.35)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.190; .516; .026

Postoperative Binocular Near Visual Outcomes at 40 cma

ParameterAT LISA GroupAT LISA tri GroupReSTOR GroupComparisonP
Month 1171517
  UNVA (logMAR)0.09 (0.13); 0.00 (0.00 to 0.40)0.17 (0.19); 0.10 (0.00 to 0.70)0.13 (0.13); 0.10 (−0.10 to 0.40)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.094; .191; .779
  DCNVA (logMAR)0.07 (0.09); 0.00 (0.00 to 0.30)0.14 (0.18); 0.10 (0.00 to 0.70)0.05 (0.13); 0.00 (−0.10 to 0.40)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.129; .524; .071
Month 3171517
  UNVA (logMAR)0.14 (0.11); 0.10 (0.00 to 0.30)0.12 (0.11); 0.10 (0.00 to 0.49)0.07 (0.13); 0.00 (−0.10 to 0.40)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.484; .054; .058
  DCNVA (logMAR)0.10 (0.09); 0.10 (0.00 to 0.30)0.05 (0.05); 0.10 (0.00 to 0.10)0.02 (0.11); 0.00 (−0.10 to 0.30)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.243; .023; .135
Month 6171517
  UNVA (logMAR)0.13 (0.13); 0.10 (−0.10 to 0.40)0.11 (0.15); 0.10 (−0.10 to 0.49)0.11 (0.11); 0.10 (−0.10 to 0.30)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.391; .500; .679
  DCNVA (logMAR)0.08 (0.09); 0.10 (−0.10 to 0.30)0.06 (0.10); 0.05 (−0.10 to 0.30)0.05 (0.07); 0.10 (−0.10 to 0.10)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.543; .328; .851
Month 12171516
  UNVA (logMAR)0.13 (0.12); 0.10 (0.00 to 0.40)0.12 (0.12); 0.10 (−0.07 to 0.30)0.10 (0.12); 0.10 (−0.16 to 0.30)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.922; .540; .524
  DCNVA (logMAR)0.07 (0.07); 0.10 (0.00 to 0.20)0.09 (0.10); 0.10 (−0.07 to 0.30)0.02 (0.07); 0.00 (−0.12 to 0.10)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.685; .097; .075

Postoperative Binocular Distance Visual Outcomesa

ParameterAT LISA GroupAT LISA tri GroupReSTOR GroupComparisonP
Month 1171517
  UDVA (logMAR)0.04 (0.21); 0.00 (−0.20 to 0.80)−0.03 (0.07); 0.00 (−0.20 to 0.10)0.01 (0.10); 0.02 (−0.20 to 0.13)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.317; .774; .192
  CDVA (logMAR)0.01 (0.06); 0.00 (−0.10 to 0.12)−0.04 (0.07); 0.00 (−0.20 to 0.02)−0.04 (0.08); 0.00 (−0.20 to −0.10)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.350; .117; .440
Month 3171517
  UDVA (logMAR)−0.01 (0.05); 0.00 (−0.10 to 0.10)−0.04 (0.10); 0.00 (−0.10 to 0.02)0.01 (0.09); 0.00 (−0.20 to 0.15)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.325; .423; .149
  CDVA (logMAR)−0.04 (0.06); 0.00 (−0.20 to 0.01)−0.06 (0.09); 0.00 (−0.10 to 0.00)−0.03 (0.08); 0.00 (−0.20 to 0.15)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.544; .871; .497
Month 6171517
  UDVA (logMAR)−0.01 (0.04); 0.00 (−0.10 to 0.04)−0.03 (0.08); 0.00 (−0.19 to 0.12)0.00 (0.07); 0.00 (−0.16 to 0.15)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.757; .251; .279
  CDVA (logMAR)−0.02 (0.04); 0.00 (−0.10 to 0.02)−0.04 (0.07); 0.00 (−0.19 to 0.02)−0.04 (0.07); 0.00 (−0.19, 0.00)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.649; .911; .754
Month 12171516
  UDVA (logMAR)−0.01 (0.06); 0.00 (−0.20 to 0.10)−0.02 (0.08); 0.00 (−0.19 to 0.13)−0.01 (0.06); 0.01 (−0.16 to 0.10)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.531; .728; .669
  CDVA (logMAR)−0.03 (0.05); −0.02 (−0.20 to 0.03)−0.04 (0.08); 0.00 (−0.22 to 0.04)−0.05 (0.07); −0.02 (−0.22 to 0.00)809M vs 839MP; 809M vs SN6AD1; 839MP vs SN6AD1.969; .397; .472
Authors

From Breyer, Kaymak und Klabe Augenchirurgie, Düsseldorf, Germany (HK, DB); Vissum Corporation, Alicante, Spain (JLA); and Hôpital Morvan, Brest, France (BC).

Supported by Carl Zeiss Meditec AG, Berlin, Germany.

The authors have no proprietary or financial interest in the materials presented herein.

AUTHOR CONTRIBUTIONS

Study concept and design (HK, JLA); data collection (HK, JLA, BC); analysis and interpretation of data (HK, DB, JLA, BC); writing the manuscript (JLA); critical revision of the manuscript (HK, DB, JLA, BC); statistical expertise (JLA); supervision (HK, JLA)

Correspondence: Hakan Kaymak, MD, Breyer, Kaymak und Klabe Augenchirurgie, Berliner Allee 15, 40212 Düsseldorf, Germany. E-mail: h.kaymak@augenchirurgie.clinic

Received: December 23, 2016
Accepted: April 18, 2017

10.3928/1081597X-20170504-04

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