Positioning of refractive rotational asymmetry multifocal intraocular lenses (MFIOLs) is important because a tilt or decentration can decrease the visual quality and produce optical side effects, causing subjective symptoms and patient dissatisfaction.1 Centration of MFIOLs is crucial to their optimum optical function and to prevent problems related to decentration and tilt, especially night vision complaints. To avoid these effects, capsular tension rings (CTRs) have been demonstrated to play a role in the stability and positioning of IOLs2,3 and can prevent IOL rotation and decentration caused by capsular bag contraction.4–7
In a previous publication,8 a CTR was implanted jointly with the C-Loop haptic design of the refractive rotational asymmetric MFIOL to study the optical and refractive stability provided by the CTR. The refractive predictability and optical stability improved when the C-Loop haptic model was implanted in combination with a CTR. Despite the use of a CTR, a different haptic design may be more adequate to stabilize the sophisticated optic of this IOL within the capsular bag.9–11 Recently, a new design of this refractive rotational asymmetry MFIOL with a plate-haptic design was introduced to improve the stability of this MFIOL.
The aim of the current study was to evaluate and compare the visual outcomes and intraocular optical quality in patients who had cataract surgery and implantation with either the C-loop haptic design with or without CTR or the plate-haptic design to ascertain which rotationally asymmetric MFIOL model provided better visual performance and intraocular optical quality.
Patients and Methods
This prospective, consecutive, randomized, interventional, comparative clinical investigation included a total of 135 eyes of 78 patients (58 patients with bilateral and 19 patients with unilateral implantation) with ages ranging between 36 and 82 years. All patients underwent cataract surgery with implantation of one of three strategies for two different models of the refractive rotationally asymmetric MFIOL. When the IOL implantation was bilateral, the same IOL model was implanted in both eyes. Patients were divided into three groups: 43 eyes implanted with the C-Loop haptic design (Lentis Mplus LS-312 MF30; Oculentis GmbH, Berlin, Germany) without CTR (C-Loop haptic only group); 47 eyes implanted with the C-Loop haptic design (Lentis Mplus LS-312 MF30; Oculentis GmbH) in combination with a CTR (C-Loop haptic with CTR group); and 45 eyes implanted with the plate-haptic design (Lentis Mplus LS-313 MF30; Oculentis GmbH) (plate-haptic group).
Inclusion criteria were patients with significant cataract or patients with significant nuclear sclerosis demanding a surgical refractive solution for far and near distance vision. The patients’ refractive astigmatism was 3.00 diopters (D) or less. Exclusion criteria were patients with any other ocular comorbidities, amblyopia, neuro-ophthalmic disease, and previous refractive corneal surgery. All patients were adequately informed and signed a consent form. The study adhered to the tenets of the Declaration of Helsinki and was approved by the local ethical committee.
IOLs and CTRs
The Lentis Mplus LS-312 MF30 (Figure 1, left) is a refractive rotational asymmetric MFIOL containing an aspheric distance vision zone combined with a 3.00 D posterior sector shaped near-vision zone and C-Loop haptic design, which has been described previously.1 The Lentis Mplus LS-313 MF30 (Figure 1, right) model has the same design as the Lentis Mplus LS-312 MF30, but with a plate-haptic design.
Figure 1. A general view of the Lentis Mplus LS-312 multifocal intraocular lens (left) and the Lentis Mplus LS-313 multifocal intraocular lens (right) (Oculentis GmbH, Berlin, Germany).
StabilEyes Capsular Tension Rings (Abbott Medical Optics, Santa Ana, CA) were used according to the protocol. These are compression-molded Perspex CQ polymethylmethacrylate rings designed to ensure capsular bag stability and promote IOL centration. The same sizes were used in all cases: expanded diameter of 13 mm and compressed size of 11.0 mm.
All surgeries were performed by two experienced surgeons (JLA and JJ) using a standard technique of suture-less microincision phacoemulsification. Topical anesthesia and a mild sedative (Midazolam; Roche, Madrid, Spain) were used. Adequate dilation was obtained with intracameral mydriasis. The incision was placed on the steepest corneal meridian, which was previously marked on the slit lamp to avoid any possible cyclorotation. CTR injection into the capsular bag was performed before IOL implantation by a syringe-style micro inserter, which was supplied with the CTR by the manufacturer (Stabil-Eyes system; Abbott Medical Optics). The MFIOL was then implanted using a specific injector (Viscoject 2.2 Cartridge-Set LP604240M; Oculentis GmbH).
Preoperative and Postoperative Examinations
Preoperatively, all patients had a full ophthalmologic examination including the evaluation of the refractive status, the distance and near visual acuities, slit-lamp examination, tonometry, and funduscopy. Distance visual acuity was measured with the Snellen charts (T type, Auto chart projector CP690; Nidek Co., Tokyo, Japan) and the near visual acuity with the standardized Radner-Vissum Reading Charts.12,13 Apart from these clinical tests, corneal topography (CSO; Costruzione Strumenti Oftalmici, Impruneta, Italy) and biometry (IOLMaster; Carl Zeiss Meditec, Jena, Germany) were performed.
Postoperatively, patients were evaluated during the follow-up at 1 day, 1 month, and 3 months after surgery by an independent certified optometrist following the same investigational protocol. The postoperative examination protocol was identical to the preoperative protocol, with the additional measurement of the ocular and intraocular optical performance. To obtain the postoperative refraction, the uncorrected distance visual acuity was measured as a starting point for the subjective refraction using an automated refractor and then the starting point for the subjective refraction was inserted in the loose lenses in the trial frame. To determine the sphere power, we fogged the test eye with positive lenses until the patient reported a deterioration in vision. We reduced the plus lenses in 0.25-D steps until the patient had no increase in readable letters. The cylindrical power and axis of manifest refraction was confirmed using cross cylinders in increments of 0.25 D. To end the manifest refraction, we fogged the eye with positive lenses and reduced them in 0.25-D steps until the patient had no increase in visual acuity. This was done to prevent overcorrection or undercorrection. The intraocular optical quality was obtained using the Visual Optics Lab software (version 6.89; Sarver and Associates Inc., Celebration, FL). This allowed us to subtract the 3-month postoperative corneal aberrations from the total ocular aberrations. In addition, the defocus curves were obtained in monocular distance vision and with the best distance refractive correction. Contrast sensitivity (CST 1800; Vision Science Research, San Ramon, CA) under photopic (85 cd/m2) and low mesopic (3 cd/m2) conditions was also evaluated 3 months after surgery.
The statistical analysis was performed using the SPSS statistical software package version 15.0 for Windows (SPSS, Inc., Chicago, IL). Normality of all data samples was evaluated by the Kolmogorov–Smirnov test. When parametric analysis was possible, the Student’s t test for paired data was performed for all parameter comparisons between preoperative and postoperative examinations. The one-way analysis of variance with Bonferroni post-hoc comparison procedure was used for the comparison between groups. If variances were not homogeneous (checked by the Levene test), the Tamhane post-hoc analysis was used. When parametric analysis was not possible, the Wilcoxon rank sum test was applied to assess the significance of differences between preoperative and postoperative data, whereas the Kruskal–Wallis test was used to compare the analyzed parameters between groups. For post-hoc analysis, the Mann–Whitney test with Bonferroni’s adjustment was used to avoid the experimental error rate in these cases. For all statistical tests, the same level of significance was used (P < .05).
Table 1 summarizes the preoperative conditions in all groups of eyes analyzed in the study. No statistically significant differences among groups were found concerning age, keratometry, axial length, and power of the implanted IOL (one-way analysis of variance and Kruskal–Wallis test, P ⩾ .24) (Table 1).
Table 1: Preoperative Conditions of Patients Included in the Three Groups
Visual and Refractive Outcomes
Table 2 summarizes the visual and refractive outcomes at 3 months postoperatively. Significant improvement after surgery in the uncorrected distance visual acuity and uncorrected near visual acuity were observed in the three groups of eyes (Wilcoxon test, P < .01). In addition, corrected distance visual acuity improved significantly in the C-Loop haptic only and plate-haptic groups (Wilcoxon test, P < .01 for both). Only the the plate-haptic group experienced a significant improvement in corrected near visual acuity (Wilcoxon test, P < .01). Regarding subjective refraction, a significant reduction in the manifest cylinder was observed in all groups (Wilcoxon test, P ⩽.03). The sphere was significantly modified in eyes for the C-Loop haptic with CTR and plate-haptic groups (Wilcoxon test, P ⩽.02).
Table 2: Postoperative Conditions 3 Months After Cataract Surgery in the Three Groups
Table 2 shows a comparative analysis of the postoperative visual and refractive outcomes at 3 months postoperatively. No statistically significant differences in the corrected distance visual acuity, uncorrected near visual acuity, distance corrected near visual acuity, corrected near visual acuity, and manifest cylinder were found among groups (Kruskal–Wallis test, P ⩾ .09). In contrast, significant differences in the postoperative sphere were found (Kruskal–Wallis test, P = .01) with negative values for the C-Loop haptic only group. In addition, the spherical equivalent was statistically significant (Kruskal–Wallis test, P = .06) with a significantly more myopic postoperative refraction for the C-Loop haptic only group.
Contrast Sensitivity Outcomes
As shown in Figure 2, no significant differences were detected in photopic and scotopic contrast sensitivity among groups (Kruskal–Wallis test, P ⩾ .05). A trend toward better contrast sensitivity outcome was observed in the C-Loop haptic with CTR group. A near to the limit statistical significance was found in photopic contrast sensitivity for the highest spatial frequencies (Kruskal–Wallis test; 12 cycles/degree, P = .06; 18 cycles/degree, P = .05).
Figure 2. Mean contrast sensitivity function under photopic (85 cd/m2) and mesopic low (3 cd/m2) conditions in the three groups of eyes analyzed: group A = eyes implanted with the C-Loop haptic design of the refractive rotationally asymmetric multifocal intraocular lens (MIOL) without using a capsular tension ring (CTR) (green line); group B = eyes implanted with the C-Loop haptic design of the refractive rotationally asymmetric MIOL using a CTR (pink line); and group C = eyes implanted with the plate-haptic design of the refractive rotationally asymmetric MIOL (orange line).
Figure 3 shows the mean defocus curve for the three groups. The statistical analysis of the results revealed that significantly better visual acuities were present in the C-Loop haptic with CTR group for the defocus levels of −2.0, −1.5, −1.0, and −0.50 D (Kruskal–Wallis test, P ⩽.03).
Figure 3. Mean defocus curve in the three groups of eyes analyzed: group A = eyes implanted with the C-Loop haptic design of the refractive rotationally asymmetric multifocal intraocular lens (MIOL) without using a capsular tension ring (CTR) (green line); group B = eyes implanted with the C-Loop haptic design of the refractive rotationally asymmetric MIOL using a CTR (pink line); and group C = eyes implanted with the plate-haptic design of the refractive rotationally asymmetric MIOL (orange line).
Intraocular Optical Quality Outcomes
Figure 4 shows the postoperative intraocular optical quality. Statistically significant differences among groups were found in total root mean square (RMS), high order RMS, and coma-like RMS aberrations (Kruskal–Wallis test, P ⩽.04); eyes from the plate-haptic group presented significantly lower values of these parameters. Regarding the intraocular Strehl ratio, no statistical differences were observed among groups. Mean values were 0.30 ± 0.04, 0.30 ± 0.05, and 0.29 ± 0.05 for the C-Loop haptic only, C-Loop haptic with CRT, and plate-haptic groups, respectively (Kruskal–Wallis test, P ⩽.95).
Figure 4. Postoperative intraocular aberrations in the three groups of eyes analyzed: group A = eyes implanted with the C-Loop haptic design of the refractive rotationally asymmetric multifocal intraocular lens (MIOL) without using a capsular tension ring (CTR) (green bars); group B = eyes implanted with the C-Loop haptic design of the refractive rotationally asymmetric MIOL using a CTR (pink bars); group C eyes implanted with the plate-haptic design of the refractive rotationally asymmetric MIOL (orange bars). RMS values (in micrometers) and standard deviation of total, higher order, tilt, and spherical-like and coma-like aberrations. In addition, the primary spherical aberration is also reported with its sign. RMS = root mean square; HO = higher order; PSA = primary spherical aberration; SSA = secondary spherical aberration
Figure 5 shows a comparative diagram with the analysis of the intraocular optical quality for a 5.0-mm pupil of three cases implanted with one of the three IOL designs analyzed in this study. These cases are representative of the general trend observed in the analyzed sample. All cases presented similar manifest refractive conditions postoperatively.
Figure 5. Comparative diagram showing the analysis of the in vivo intraocular optical quality for a 5.0-mm pupil of three cases implanted with one of the three models analyzed in this study. (Left) C-Loop haptic design of the refractive rotationally asymmetric multifocal intraocular lens (MIOL) without using a capsular tension ring (CTR). (Center) C-Loop haptic design of the refractive rotationally asymmetric MIOL using a CTR. (Right) Plate-haptic design of the refractive rotationally asymmetric MIOL. Top row: intraocular wavefront higher-order aberrations. Middle row: three-dimensional point spread function. Bottom row: Snellen optotype simulation considering only the effect of higher-order aberrations. All cases presented similar manifest refractive conditions postoperatively.
Several reports1,14–17 have confirmed visual rehabilitation after cataract surgery with implantation of the refractive rotational asymmetry MFIOL, but the outcomes obtained are highly dependent on the positional stability of the IOL within the capsular bag.8 In the current study, no statistically significant differences were found in distance and near visual acuities among groups after surgery, which confirms the efficacy of these different IOLs designed for patient visual rehabilitation. This was consistent with previous reports also using the same IOL models.1,8 Regarding postoperative refraction, a statistically significant difference was found in manifest sphere, with a trend toward more negative values in the C-Loop haptic only group. The same trend was observed for the spherical equivalent in the C-Loop haptic only group, with less negative values for the plate-haptic group. These refractive differences could be due to a different stability of the IOL within the capsular bag with and without CTR implantation and the plate-haptic design.
Better results were also found for eyes implanted with the C-Loop haptic model in combination with CTR for high spatial frequencies. These outcomes could be another consequence of the different optical behavior of the evaluated IOL models in the capsular bag.
When the defocus curves were compared among groups, significant differences were found for defocus levels of −2.0, −1.5, −1.0, and −0.50 D, which corresponds with intermediate visual acuity, with better values for those eyes implanted with the C-Loop haptic design in combination with CTR. These results are in agreement with our previous publication.8 The good vision for defocus values from −1.0 to −1.50 D reveals that this IOL is also able to restore intermediate vision, which was surprising because the lens has one area for distance and another for near vision. Reasons that might explain this finding include the gradual transition zone between both areas of the IOL, the slight induction of specific higher-order aberrations providing a larger depth of focus,19,20 the effect of a residual ametropia after implanting these lenses, the effective add power change, and the intermediate vision improvement.
Significantly lower amounts of intraocular total RMS, intraocular high order RMS, and intraocular coma-like RMS aberrations were observed in eyes implanted with the plate-haptic design. Due to the geometrical asymmetry21 of the IOL analyzed in this study, the postoperative intraocular optical analysis showed the presence of primary coma and coma-like aberrations with higher magnitude in eyes implanted with the C-Loop haptic design without CTR. We considered that optical, refractive, and visual performance provided by multifocal IOLs is related to IOL rotational stability. Previous studies1,8 with the C-Loop haptic design have demonstrated poor stability of the IOL within the capsular bag and suggested a new plate-haptic design to improve this issue.9–11 However, when we analyzed the intraocular tilt aberrations, we found that no significant differences among groups were detected; otherwise all groups presented large amounts of this aberration. There are several ways of assessing the decentration, rotation, and tilt of an IOL. These include slit-lamp assessment, retroillumination photography, Scheimpflug imaging, and measurements using Purkinje reflections.22–25 Although we recognize the limitations of tilt decentration and rotation measurements in the current study, our findings indicate that it is unclear which IOL haptic design allows more effective control of IOL tilting.
The refractive rotationally asymmetric MFIOL allows near, intermediate, and distance visual restoration in pseudophakic eyes. Previous reports have demonstrated that significantly better intermediate visual outcomes are obtained when it is implanted in combination with a CTR. However, better refractive predictability and intraocular optical qualities are obtained with the plate-haptic design, even when combined with a CTR. Different intraocular optical behavior should be expected with the different haptic designs. However, the plate-haptic design is a more convenient model to obtain better optical and visual outcomes with the MFIOL model because it has a better IOL stability. In addition, a longer follow-up is required to confirm the stability of the visual outcomes achieved with these types of MFIOL technologies.
- Alió JL, Piñero DP, Plaza-Puche AB, Rodriguez Chan MJ. Visual outcomes and optical performance of a monofocal intraocular lens and a new-generation multifocal intraocular lens. J Cataract Refract Surg. 2011;37:241–250 doi:10.1016/j.jcrs.2010.08.043 [CrossRef] .
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Preoperative Conditions of Patients Included in the Three Groups
|Parameter||C-Loop Haptic Only Group||C-Loop Haptic With CTR Group||Plate-Haptic Group||P|
| Mean ± SD||62.68 ± 12.4||60.59 ± 7.77||65.38 ± 9.47|
| Range||36 to 82||48 to 82||47 to 82|
| Mean ± SD||0.81 ± 0.41||0.67 ± 0.53||0.69 ± 0.53|
| Range||0.01 to 2.00||0.00 to 2.00||0.02 to 2.00|
| Mean ± SD||+0.91 ± 2.37||+1.80 ± 2.97||+1.15 ± 3.24|
| Range||−3.50 to +5.50||−7.00 to +8.50||−8.50 to 6.00|
| Mean ± SD||−0.81 ± 0.83||−0.80 ± 0.64||−0.86 ± 0.67|
| Range||−3.00 to 0.00||−2.50 to 0.00||−3.00 to 0.00|
|Spherical equivalent (D)||.47b|
| Mean ± SD||+0.50 ± 2.41||+1.40 ± 2.87||+0.72 ± 3.35|
| Range||−4.88 to 4.88||−7.25 to 7.25||−9.00 to 5.25|
| Mean ± SD||0.12 ± 0.16||0.05 ± 0.10||0.13 ± 0.19|
| Range:||0.00 to 0.70||0.00 to 0.44||−0.08 to 0.82|
| Mean ± SD||0.67 ± 0.45||0.82 ± 0.33||0.78 ± 0.38|
| Range||0.00 to 1.22||0.22 to 1.40||0.10 to 1.40|
| Mean ± SD||0.15 ± 0.16||0.08 ± 0.12||0.17 ± 0.22|
| Range||0.00 to 0.70||0.00 to 0.40||0.00 to 1.00|
|Mean keratometry (D)||.91a|
| Mean ± SD||43.78 ± 2.03||43.64 ± 1.57||43.77 ± 1.45|
| Range||39.63 to 49.55||39.46 to 46.46||40.66 to 47.04|
|Axial length (mm)||.82b|
| Mean ± SD||23.19 ± 1.26||22.95 ± 1.18||23.13 ± 1.03|
| Range||20.83 to 26.85||20.76 to 27.49||21.47 to 25.82|
|IOL power (D)||.53b|
| Mean ± SD||21.02 ± 2.79||21.97 ± 3.76||21.46 ± 2.98|
| Range||14.00 to 26.50||10.50 to 30.00||15.50 to 27.00|
Postoperative Conditions 3 Months After Cataract Surgery in the Three Groups
|Parameter||C-Loop Haptic Only Group||C-Loop Haptic With CTR Group||Plate-Haptic Group||Pa|
| Mean ± SD||0.14 ± 0.18||0.17 ± 0.21||0.16 ± 0.11|
| Range||0.00 to 0.70||−0.02 to 0.82||0.00 to 0.52|
| Mean ± SD||−0.01 ± 0.64||+0.16 ± 1.01||+0.16 ± 0.40|
| Range||−3.00 to +1.25||−3.25 to +1.25||−1.00 to +1.25|
| Mean ± SD||−0.45 ± 0.71||−0.53 ± 0.46||−0.39 ± 0.49|
| Range||−3.25 to 0.00||−1.75 to 0.00||−2.00 to 0.00|
|Spherical equivalent (D)||.06|
| Mean ± SD||−0.23 ± 0.75||−0.10 ± 1.06||−0.03 ± 0.49|
| Range||−3.25 to 0.75||−3.88 to 1.25||−1.25 to 1.00|
| Mean ± SD||0.05 ± 0.10||0.02 ± 0.06||0.03 ± 0.06|
| Range||0.00 to 0.52||−0.08 to 0.30||−0.08 to 0.30|
| Mean ± SD||0.21 ± 0.17||0.22 ± 0.16||0.20 ± 0.13|
| Range||0.00 to 0.90||0.00 to 0.52||0.00 to 0.52|
| Mean ± SD||0.23 ± 0.21||0.15 ± 0.12||0.17 ± 0.13|
| Range||0.00 to 0.70||0.00 to 0.52||0.00 to 0.52|
| Mean ± SD||0.09 ± 0.13||0.10 ± 0.10||0.07 ± 0.08|
| Range||0.00 to 0.70||0.00 to 0.40||0.00 to 0.30|