EDOF IOLs showed superior tolerance to tilt and decentration compared with full range-of-field IOLs.
Abstract
Purpose:
To compare the impact of intraocular lens (IOL) decentration and tilt on the visual performance of 5 presbyopia-correcting IOLs in patients after cataract surgery.
Setting:
Zhongshan Ophthalmic Center, Guangzhou, China.
Design:
Prospective, observational study.
Methods:
Patients with cataract undergoing uneventful phacoemulsification with extended depth-of-focus (EDOF) IOLs (Vivity, ZXR00) and full range-of-field (RoF) IOLs (ZMB00, TFNT00, ZFR00V) were enrolled. Each IOL group was stratified by the third quartile (Q3) of IOL tilt and decentration measured by CASIA2. Intraocular higher-order aberrations (HOAs), contrast sensitivity (CS), modulation transfer function (MTF), Strehl ratio, and patient-reported outcomes 3 months postoperatively were compared between subgroups.
Results:
260 patients (260 eyes) were included. Based on the Q3 values, eyes were categorized into tilt subgroups T1 (<5.63 degrees) and T2 (≥5.63 degrees), and decentration subgroups D1 (<0.24 mm) and D2 (≥0.24 mm). No significant differences in visual quality were observed between Vivity and ZXR00 subgroups. By contrast, T2 subgroups of TFNT00, ZMB00, and ZFR00V exhibited higher HOAs and coma, and lower CS, than their T1 subgroups (all P < .05). The D2 subgroup of ZFR00V showed increased HOAs and coma, and reduced CS under photopic and mesopic conditions with glare (all P < .05). The D2 subgroup of ZMB00 demonstrated higher HOAs and coma, as well as lower MTF (all P < .05). The D2 subgroup of TFNT00 reported significantly lower patient satisfaction (3.25 ± 0.46 vs 3.83 ± 0.38, P = .008).
Conclusions:
EDOF IOLs (ZXR00 and Vivity) demonstrated greater tolerance to tilt and decentration compared with FULL-RoF IOLs (ZMB00, TFNT00, and ZFR00V).
Intraocular lens (IOL) decentration and tilt could increase higher-order aberrations (HOAs), particularly coma, which can deteriorate visual quality.1,2 Clinically significant IOL decentration (≥0.4 mm) and tilt (≥7 degrees) have been shown to impair the modulation transfer function (MTF) of aspheric monofocal IOLs.3 Compared with monofocal IOLs, presbyopia-correcting IOLs (PC-IOLs) are more sensitive to misalignment.4 Tilt greater than 2 degrees and decentration exceeding 0.2 mm could reduce contrast sensitivity (CS) and cause visual disturbances, including glare, halos, and starbursts.5–7 With the increasing adoption of premium IOLs in cataract surgery, evaluating the tolerance of PC-IOLs to tilt and decentration has become an important clinical consideration.
According to the latest IOL classification by the ESCRS, simultaneous vision IOLs can be divided into 2 major categories: partial range-of-field (RoF) IOLs and full RoF IOLs, and variations in optical design among these IOLs may account for their differing sensitivities to misalignment.8,9 Previous studies have reported that bifocal IOLs are more susceptible to decentration than diffractive extended depth-of-focus (EDOF) IOLs, whereas trifocal IOLs exhibit a greater decline in optics performance in response to tilt.5,10,11 Recently, several new PC-IOLs have been introduced into clinical practice. The nondiffractive EDOF IOL (Vivity) offers a continuous range of vision with a similarly low incidence of dysphotopsias as monofocal.12 The full RoF IOL (ZFR00V), which integrates bifocal and EDOF technologies, provides full-range vision from distant to near (33 cm).13 A diffractive trifocal IOL (TFNT00) has been shown to provide superior near vision at 40 cm compared with EDOF IOLs.14 However, the tolerance of these newer PC-IOLs to decentration and tilt remains unclear.
To date, research on tolerance of PC-IOLs to misalignment remains limited and has relied exclusively on the OPD-Scan III aberrometer, which indirectly estimates tilt through aberration analysis and assesses decentration 2-dimensionally through retroillumination.6,15–17 The newly developed swept-source anterior segment optical coherence tomography (SS-AS-OCT) system CASIA2 enables direct 3D measurement of IOL position relative to the corneal topographic axis, providing improved accuracy and repeatability.15,18,19 In this study, the authors compare the tolerance of 5 PC-IOLs to decentration and tilt using CASIA2, offering clinically relevant guidance for IOL selection.
METHODS
This prospective observational study was approved by the Institutional Review Board/Ethics Committee of Zhongshan Ophthalmic Center, Sun Yat-sen University (2019KYPJ033) and followed the tenets of the Declaration of Helsinki. All participants provided written informed consent before cataract surgery for the use of their clinical data.
Participants
Patients with cataract who underwent uneventful phacoemulsification with implantation of TECNIS Symfony (ZXR00), TECNIS bifocal (ZMB00), or TECNIS Synergy (ZFR00V) IOLs (Johnson & Johnson Vision), or an AcrySof IQ Vivity (DFT015) or PanOptix (TFNT00) IOL (Alcon Laboratories, Inc.) were continuously recruited from Zhongshan Ophthalmic Center between March 16, 2022, and March 2, 2025. The right eye was selected if both eyes met the criteria. The exclusion criteria were as follows: (1) presence of intraoperative or postoperative complications; (2) coexistence of other ocular pathologies that may affect visual acuity, such as corneal abnormalities, uncontrolled glaucoma, or history of uveitis and any condition suspicious for a weak zonular apparatus; (3) presence of systemic diseases that may influence ocular status, such as hyperthyroidism; (4) previous ocular trauma or surgery; and (5) inability to cooperate with examinations or complete follow-up assessments.
Preoperative Examinations
All patients underwent comprehensive preoperative ophthalmic examinations including visual acuity assessment, intraocular pressure, slitlamp examination, fundoscopy, B-scan ultrasonography, corneal endothelial microscopy, and optical biometry (IOL Master700, Carl Zeiss Meditec AG).
Surgical Procedure
All surgical procedures were conducted by 2 experienced ophthalmologists (L.L., X.T.) after standardized procedures. A 2.2 mm clear corneal incision was made temporally before a 5.5 mm continuous curvilinear capsulorhexis, hydrodissection, and phacoemulsification. The IOL was implanted in the capsular bag and checked for proper centering. After thorough removal of the ophthalmic viscosurgical device, the incision was hydrated. All participants received tobramycin/dexamethasone eyedrops (Tobradex [Alcon Laboratories, Inc.]) 4 times a day for 1 week postoperatively.
Postoperative Examinations
Postoperative follow-up examinations were performed 3 months postoperatively. Corrected distance visual acuity (CDVA) was recorded monocular using the Early Treatment Diabetic Retinopathy Study (Precision Vision) charts at 4 m. The root mean square of the intraocular wave aberrations, MTF, and Strehl ratio (SR) at 5 mm pupil diameters were evaluated with the OPD-Scan III (Nidek Co., Ltd.). Monocular CS was measured for spatial frequencies of 3 cycles per degree (cpd), 6 cpd, 12 cpd, and 18 cpd under 4 standard conditions: photopic (85 cd/m2), mesopic (3 cd/m2), and photopic/mesopic with glare (40 lux), at a distance of 2.5 m using the CSV-1000E (Vector Vision, Haag-Streit International).20 Patient satisfaction was evaluated with the Catquest-9SF questionnaire, and total scores were counted.21
IOL tilt and decentration were measured using a SS-AS-OCT device (CASIA2, Tomey Corp.). The device uses a 1310 nm swept laser operating at 50 000 A-scans per second, enabling high-resolution cross-sectional and volumetric imaging of the anterior segment.22 After adequate mydriasis (pupil diameter ≥6 mm), volumetric scans were obtained in IOL scan mode according to established protocols.23 The anterior segment was reconstructed in 3D using the built-in CASIA2 software (SS2000). IOL tilt and decentration were then automatically quantified in 3D space, followed by manual verification and, if necessary, fine-tuning by a single experienced clinician to ensure accuracy.
Statistical Analysis
Normality and homogeneity of variance were assessed using the Shapiro-Wilk and Levene tests, respectively. Continuous variables were presented as mean ± SD for normally distributed data or median (interquartile range [IQR]) for nonnormally distributed data, while categorical variables were reported as frequencies (%). For 2-group comparisons, independent samples t tests or Mann-Whitney U tests were used based on data distribution. For multigroup comparisons, 1-way ANOVA with the Tukey post hoc test for pairwise comparisons was used when the data met normality and homogeneity of variance; otherwise, the Kruskal-Wallis test followed by the Dunn post hoc test was applied. Categorical variables were compared between groups using the chi-square test or Fisher exact test when expected frequencies were <5. Statistical analyses were conducted using R software (v. 4.2.0; R Foundation for Statistical Computing). Statistical significance was set at P < .05 (2-sided).
RESULTS
Participant Characteristics
A total of 260 eyes from 260 participants were included in the study. Of these, 81 eyes received ZXR00, 77 received ZMB00, 47 received Vivity, 28 received TFNT00, and 27 received ZFR00V. No statistically significant differences were observed among the groups in age, sex, axial length, anterior chamber depth, lens thickness, and white-to-white distance. Postoperative CDVA also did not differ significantly among the IOL groups. A significant difference was found in spherical equivalent among groups (P < .001), attributed to the mini-monovision design applied in the Vivity and ZXR00 groups (Table 1).
Table 1.
Demographic and clinical characteristics of participants
| Parameter | ZXR00 | ZMB00 | Vivity | TFNT00 | ZFR00V | P value |
| Eyes, n | 81 | 77 | 47 | 28 | 27 | — |
| Female, n (%) | 45 (55.56) | 44 (57.14) | 21 (44.68) | 19 (67.86) | 13 (48.15) | .338 |
| Age (y) | 61.59 ± 10.76 (35, 82) | 62.96 ± 8.65 (38, 83) | 63.98 ± 10.70 (35, 87) | 60.46 ± 9.89 (46, 81) | 60.44 ± 10.75 (32, 79) | .428 |
| AL (mm) | 23.99 ± 1.29 (21.55, 27.50) | 23.67 ± 0.90 (22.08, 26.92) | 23.78 ± 1.22 (21.88, 27.62) | 23.94 ± 1.20 (21.89, 26.18) | 24.13 ± 1.03 (22.87, 27.35) | .273 |
| ACD (mm) | 3.22 ± 0.49 (2.08, 4.93) | 3.13 ± 0.35 (2.27, 3.91) | 3.27 ± 0.52 (2.48, 5.15) | 3.31 ± 0.41 (2.44, 3.99) | 3.23 ± 0.24 (2.90, 3.81) | .289 |
| LT (mm) | 4.41 ± 0.47 (3.16, 5.38) | 4.41 ± 0.45 (3.29, 5.32) | 4.43 ± 0.44 (3.08, 5.44) | 4.14 ± 0.52 (3.33, 5.58) | 4.40 ± 0.39 (3.54, 5.18) | .067 |
| WTW (mm) | 11.84 ± 0.42 (10.80, 12.80) | 11.84 ± 0.45 (10.90, 12.90) | 11.91 ± 0.44 (10.90, 12.80) | 11.69 ± 0.40 (10.80, 12.30) | 11.84 ± 0.32 (11.20, 12.60) | .318 |
| SE (D) | −0.45 ± 0.37 (−1.38, 0.13) | −0.06 ± 0.32 (−1.00, 1.13) | −0.45 ± 0.35 (−1.13, 0.25) | −0.05 ± 0.25 (−0.50, 0.63) | −0.29 ± 0.25 (−1.00, 0.00) | <.001*** |
| Post-CDVA (logMAR) | 0.04 ± 0.07 (−0.10, 0.20) | 0.04 ± 0.07 (−0.10, 0.20) | 0.05 ± 0.05 (−0.10, 0.10) | 0.04 ± 0.06 (−0.10, 0.10) | 0.04 ± 0.06 (−0.10, 0.20) | .954 |
| IOL tilt (degrees) | 4.45 ± 1.47 (1.10, 9.00) | 4.87 ± 1.38 (1.80, 8.10) | 4.99 ± 1.26 (2.80, 7.60) | 4.67 ± 1.53 (1.90, 7.20) | 5.08 ± 0.68 (3.30, 6.60) | .233 |
| IOL decentration (mm) | 0.18 ± 0.12 (0.01, 0.60) | 0.18 ± 0.13 (0.03, 0.56) | 0.23 ± 0.13 (0.03, 0.48) | 0.21 ± 0.10 (0.02, 0.45) | 0.17 ± 0.09 (0.04, 0.35) | .410 |
ACD = anterior chamber depth; AL = axial length; LT = lens thickness; SE = spherical equivalent; WTW = white to white
Values are presented as mean ± SD unless otherwise indicated
***P < .001
Figure 1 illustrates the distribution of IOL tilt and decentration among the 5 IOL groups. The mean value of IOL tilt was 4.78 ± 1.33 degrees (median, 4.70 degrees; IQR, 3.80 to 5.63 degrees). The mean tilt axis tended toward the inferotemporal direction. The average value of IOL decentration was 0.19 ± 0.11 mm (median, 0.17 mm; IQR, 0.11 to 0.24 mm), and the decentration axis could appear at any direction without any tendency. There were no statistically significant differences in the magnitude of IOL tilt (F = 1.40, P = .233) or decentration (F = 1.00, P = .410) among 5 IOL groups.
Figure 1.
The orientations and values of the IOL tilt (degrees) (A) and decentration (mm) (B) of 5 presbyopia-correcting IOLs.
Impact of IOL Tilt on Visual Quality
For subgroup analysis, each IOL group was categorized into T1 group (<5.63 degrees) and T2 group (≥5.63 degrees) based on the third quartile (Q3) value of tilt.
Figure 2 compares intraocular aberrations under a 5 mm pupil between 2 subgroups for each IOL group. In the ZFR00V and TFNT00 group, total HOAs (ZFR00V: 0.46 ± 0.05 vs 0.62 ± 0.15, P = .020; TFNT00: 0.31 ± 0.06 vs 0.46 ± 0.07, P = .006), coma (ZFR00V: 0.21 ± 0.06 vs 0.30 ± 0.08, P = .014; TFNT00: 0.09 ± 0.04 vs 0.17 ± 0.05, P = .016), and spherical aberration (ZFR00V: 0.33 ± 0.08 vs 0.42 ± 0.08, P = .024; TFNT00: 0.06 ± 0.02 vs 0.10 ± 0.02, P = .014) were significantly higher in the T2 subgroup. For ZMB00, total HOAs (0.39 ± 0.07 vs 0.49 ± 0.09, P < .001) and coma (0.18 ± 0.10 vs 0.27 ± 0.14, P = .010) were significantly greater in the T2 subgroup. No significant differences were observed between tilt subgroups in the Vivity and ZXR00 subgroups (all P > .05). Comparisons of whole-eye and corneal aberrations between the tilt subgroups are presented in Supplemental Table 1 (available at http://links.lww.com/JRS/B547).
Figure 2.
Comparison of the aberrations between the 2 tilt subgroups within each IOL group. Error bars represent standard errors of the mean. RMS = root mean square; THOA = total HOA. *P < .05; **P < .01; ***P < .001.
Supplemental Table 2 presents the comparison of objective and subjective visual quality between tilt subgroups across different IOL types. In the ZFR00V group, the T2 subgroup exhibited lower CS at 18 cpd under photopic, mesopic, and mesopic-with-glare conditions (all P < .05). In the TFNT00 group, CS at 18 cpd under photopic conditions was significantly lower in the T2 subgroup compared with the T1 subgroup (1.04 ± 0.32 vs 0.67 ± 0.14, P = .001). In the ZMB00 group, CS at 6 cpd under photopic glare conditions was reduced in the T2 subgroup (1.88 ± 0.27 vs 1.75 ± 0.21, P = .037). No significant differences in CS were observed between tilt subgroups for the Vivity and ZXR00 groups (all P > .05). There were no significant differences among tilt subgroups across all 5 IOL types in the area under the MTF curve, SR, patient satisfaction, or Catquest-9SF questionnaire scores (all P > .05).
Impact of IOL Decentration on Visual Quality
For subgroup analysis, each IOL type was categorized into D1 group (<0.24 mm) and D2 group (≥0.24 mm) based on the Q3 value of decentration.
Figure 3 compares intraocular aberrations under a 5 mm pupil between 2 decentration subgroups for each IOL type. In the ZFR00V and ZMB00 group, total intraocular HOAs (ZFR00V: 0.46 ± 0.05 vs 0.61 ± 0.14, P = .009; ZMB00: 0.40 ± 0.08 vs 0.47 ± 0.10, P = .008) and coma (ZFR00V: 0.20 ± 0.06 vs 0.31 ± 0.05, P < .001; ZMB00: 0.18 ± 0.09 vs 0.30 ± 0.14, P = .002) were significantly greater in the D2 subgroup than in the D1 subgroup. No significant differences in intraocular aberrations were observed between subgroups in the ZFR00V, ZXR00, Vivity, and TFNT00 groups (all P > .05). Supplemental Table 3 (available at http://links.lww.com/JRS/B547) summarizes the comparisons of whole-eye and corneal aberrations between the decentration subgroups.
Figure 3.
Comparison of the aberrations between the 2 decentration subgroups within each IOL group. Error bars represent standard errors of the mean. RMS = root mean square; THOA = total HOA. *P < .05; **P < .01; ***P < .001.
Supplemental Table 4 presents the comparison of objective and subjective visual quality between decentration subgroups across different IOL types. In the ZFR00V group, the D2 subgroup showed reduced CS at 18 cpd under photopic (1.15 ± 0.40 vs 0.82 ± 0.12, P = .004) and mesopic conditions (1.07 ± 0.41 vs 0.72 ± 0.25, P = .013) with glare. In the ZMB00 group, the area under the MTF curve was significantly lower in the D2 subgroup compared with the D1 subgroup (58.75 ± 16.83 vs 45.81 ± 10.11, P < .001). In the TFNT00 group, patient satisfaction was significantly lower in the D2 subgroup (3.85 ± 0.37 vs 3.25 ± 0.46, P = .008).
DISCUSSION
To the authors' knowledge, this is the first study to evaluate and compare the tolerance of 5 PC-IOLs to tilt and decentration using CASIA2, including a full RoF IOL (ZFR00V) and an EDOF IOL (Vivity). The authors found that Vivity and ZXR00 demonstrated the highest tolerance to both tilt and decentration. ZFR00V was more susceptible to IOL misalignment, as reflected in increased intraocular aberrations and reduced CS compared with ZMB00, TFNT00, Vivity, and ZXR00.
PC-IOLs seem to be more susceptible to tilt and decentration than monofocal IOLs. Under comparable degrees of misalignment, TFNT00 has been shown to exhibit poorer MTF at distance compared with the monofocal IOL (SN60WF).4 This difference is primarily attributed to variations in optical design.9 When IOL position changed, the optical zones of PC-IOLs become misaligned with the pupil, disrupting the distribution of light across multiple focal points and thereby reducing clarity and CS at various distances.24 The impact of positional changes also differs among PC-IOL designs.9 For instance, previous studies have shown that under 0.2 mm decentration, refractive bifocal IOLs exhibit lower MTF compared with diffractive bifocal IOLs.7 With the increasing adoption of newly developed IOLs in clinical practice, evaluating and comparing their tolerance to misalignment is essential for informed IOL selection.
In this study, when tilt is ≥5.63 degrees, the full RoF IOLs (ZMB00, TFNT00, and ZFR00V) showed increased intraocular total HOAs and coma, as well as reduced CS. By contrast, neither the nondiffractive EDOF IOL (Vivity) or the diffractive EDOF IOL (ZXR00) was significantly affected by tilt. A previous study using the OPD-Scan III reported that the trifocal IOL (839 MP) was more susceptible to tilt in CS than ZXR00.5 However, the OPD-Scan III estimates IOL tilt indirectly by analyzing intraocular tilt aberrations. In our study, we found that HOAs in ZXR00 IOLs had no significant differences in tilt subgroups, which is in line with previous findings showing no correlation between HOAs and tilt when measured using OPD-Scan III.11 Taken together, our findings suggest that both nondiffractive and diffractive EDOF IOLs exhibit greater tolerance to tilt compared with full RoF IOLs.
This study found that when decentration is ≥0.24 mm, ZMB00 and TFNT00 exhibited poorer objective and subjective visual quality, whereas the EDOF IOLs (Vivity and ZXR00) were not significantly affected by decentration. A previous study reported that when IOL decentration is >0.25 mm, MTF and point spread function values significantly deteriorated for ZMB00, but not for ZXR00.10 However, that studies relied on OPD measurements, which assess IOL decentration using 2-dimensional imaging through specialized image-processing software.15–17 Furthermore, the authors' previous research demonstrated that ZMB00 was more sensitive to preoperative crystalline lens decentration than ZXR00.25 Overall, these findings suggest that the nondiffractive EDOF IOL and the diffractive EDOF IOL exhibit greater tolerance to decentration compared with multifocal IOLs.
To date, no study has directly compared the tolerance to tilt and decentration among ZFR00V, Vivity, and ZXR00. The findings indicate that compared with ZXR00 and Vivity, CS under mesopic with glare conditions was more susceptible to IOL tilt and decentration in ZFR00V. This may be attributed to the optical design principles. Unlike diffractive IOLs that concentrate light energy at fixed foci through diffractive rings, Vivity extends the focal range using X-wave technology, which provides tolerance to IOL misalignment comparable with that of monofocal IOLs.26 Compared with ZFR00V, ZXR00 features fewer diffractive rings and a larger central ring diameter, which may contribute to its reduced sensitivity to IOL misalignment.
Several limitations of this study should be addressed. First, this study evaluated the tolerance to tilt and decentration among 5 PC-IOLs at 3 months postoperatively; therefore, longer-term follow-up is needed to determine whether these outcomes remain consistent over time. Second, this was a single-center study, which may restrict the generalizability of the findings. Third, the sample sizes for some IOL subgroups were relatively small. Further studies with larger sample sizes, longer follow-up periods, and multicenter designs are necessary to confirm and expand on our findings.
In conclusion, compared with full RoF IOLs, the EDOF IOLs demonstrated greater tolerance to tilt and decentration, making them more suitable for patients with higher risk of IOL misalignment, such as those with high myopia, a history of pars plana vitrectomy, or pseudoexfoliation syndrome.
WHAT WAS KNOWN
IOL tilt and decentration could affect postoperative visual quality in patients undergoing cataract surgery.
Different types of presbyopia-correcting IOLs exhibit varying tolerance to tilt and decentration, and related research remains limited.
WHAT THIS PAPER ADDS
Compared with full range of field IOLs, the EDOF IOLs seem to exhibit better tolerance to tilt and decentration.
Footnotes
This study was supported by the National Natural Science Foundation of China (Grant Nos. 82571189 and 82571188), the Natural Science Foundation of Guangdong Province (Grant No. 2025A1515012910), and the Guangzhou Major Difficult and Rare Diseases project (Grant No. 2024MDRD05).
X. Hu and J. Zhang contributed equally to this work.
Disclosures: None of the authors have any financial or proprietary interest in any material or method mentioned.
First author:
Xiaofei Hu, MD
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Vision Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, Guangdong, China
Contributor Information
Xiaofei Hu, Email: huxf23@mail2.sysu.edu.cn.
Jiaqing Zhang, Email: zhangjiaqing@gzzoc.com.
Yu Zhang, Email: wantutu52@163.com.
Wenlu Yu, Email: yuwenlu1106@163.com.
Haorui Yuan, Email: yuanhr5@mail2.sysu.edu.cn.
Xiaozhang Qiu, Email: 625215149@qq.com.
Shengsong Huang, Email: hshengs@mail.sysu.edu.cn.
Zhenzhen Liu, Email: liuzhenzhen@gzzoc.com.
Weirong Chen, Email: chenwr_q@aliyun.com.
Lixia Luo, Email: luolixia@gzzoc.com.
Xuhua Tan, Email: tanxh6@mail.sysu.edu.cn.
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