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Clinical impact of intraocular lens tilt and decentration: a cross-sectional study

Abstract

Purpose

To assess the impact of intraocular lens (IOL) tilt and decentration on visual performance within a clinical setting. Additionally, to explore the correlation between the capsulorhexis characteristics and IOL tilt and decentration.

Methods

This is a prospective study where patients who underwent uneventful cataract surgery and implanted with IOL Clareon CNA0T0 were evaluated with at least three months of follow-up. Best distance corrected visual acuity (BDCVA) and distance corrected intermediate visual acuity (DCIVA) were evaluated. Also, an anterior swept-source optical coherence tomography (OCT) was used to measure the IOL centration and tilt. The capsulorhexis characteristics were described by the area, perimeter, main semi-axes and roundness.

Results

A total of 246 eyes from 123 patients, 52 males and 71 females, were included in this study. The mean age was 73.75 ± 8.27 years old. The mean tilt was 5.31 ± 1.42 degrees and mean value of decentration was 0.27 ± 0.16 mm. Monocular BDCVA and DCIVA were 0 ± 0.05 and 0.37 ± 0.12 LogMAR respectively. The mean capsulorhexis area was 25.36 ± 6.42 mm2 and the mean roundness score was 0.93 ± 0.05. The correlation index between IOL tilt and BDCVA was 0.02 (p = 0.78). IOL tilt was not correlated with DCIVA (p = 0.1).

Conclusions

The tilt and decentration measured for this IOL in this single-arm study were consistent with previously reported ranges, but no direct comparisons were performed. BCDVA and DCIVA are low correlated with those parameters and similarly, the shape and regularity of the capsulorhexis have no significant correlation with the tilt and decentration.

Peer Review reports

Introduction

Cataract surgery is one of the most frequent surgeries worldwide, its methods and the technology of intraocular lens (IOL) are evolving rapidly [1,2,3,4,5]. As a result, the patient´s vision performance after this surgery is subsequently improving through the years [6, 7]. This improvement is explained by the emergence of new IOL formulas, which imply different approaches to calculate the effective lens position (ELP), but also the commercialization of new IOL designs.

It is well known that ELP is a crucial parameter in the IOL calculation, an error in this variable leads to a myopic or hyperopic residual refraction. Nevertheless, more variables regarding the IOL position have a role to play in the visual performance. A perfect centration of the IOL in the visual axis is not always possible and even if that circumstance were to occur, mild IOL rotation and decentration are frequent in the early postoperative cataract surgery [8, 9]. A normal value for this type of decentering can be around 0.20 mm [10]but it is a variable that is associated with the IOL haptics design, axial length or using capsular tension ring [11,12,13]. IOL tilt is another forced inconvenience that we should consider, indeed there have been numerous publications on this topic in recent years that not only try to measure but also to predict [14,15,16]. A normal value of the IOL tilt is around 5–6° inferotemporal. A normal IOL tilt value is approximately 5–6° in the inferotemporal direction. This tilt has been found to correlate with both axial length and preoperative crystalline lens thickness [17,18,19].

IOL decentration has an impact on the visual quality of the final image projected on the retina. It is well known that decentration in any lens produces a prismatic effect described by the Prentice’s rule [20]. Various studies concluded that higher rates of IOL decentration are associated with higher amounts of astigmatism and coma [21, 22]. Similarly, IOL tilt was early associated with residual astigmatism [23]and subsequently, this topic was studied more extensively using optical software. It seems that IOL tilt has a repercussion in the residual astigmatism but also in the coma-like aberrations [24, 25]. Nevertheless, IOL design could mitigate the image degradation resulted by decentration and tilt [26, 27].

The purpose of this study is to analyze the correlation between tilt, decentration and BDCVA and DCIVA. This paper aims to determine whether these parameters impact vision or refraction. Furthermore, we explore the characterization of the capsulorhexis and its correlation with IOL tilt and decentration.

Materials and methods

Settings

This cross-sectional study was conducted at the Ophthalmology Department of Fundación Jiménez Díaz Hospital between November 2023 and June 2024. The local institutional review board (Comité de Etica de la Investigación Fundación Jimenez Diaz. Code: PIC204-23) approved the study protocol, which complies with the tenets of the Declaration of Helsinki. Informed consent was obtained from all subjects following an explanation of the nature and possible consequences of the study. Patients and the public were not involved in the design, conduct, reporting, or dissemination of this research.

Patient eligibility and IOL model

Patients who underwent uneventful cataract surgery of both eyes and implanted with Clareon® CNAT0 with a minimum follow up of 3 months were included. Inclusion criteria comprehend patients with low preoperative astigmatism (keratometric readings below 1D) and axial length between 22- and 26-mm. Patients with ocular pathologies that could affect vision were discarded such as amblyopia, retinal or corneal diseases. Also, pathologies that could affect the zonular integrity such as Marfan syndrome or others related with collagen. We decided to exclude those patients with Nd-YAG capsulotomy because of possible interactions with IOL position or capsulorhexis interaction. Pseudoexfoliation syndrome was not specifically excluded, as the study was designed to reflect real-life clinical conditions. No cases with documented pseudoexfoliation were identified in the surgical records.

The Clareon® CNA0T0 intraocular lens (Alcon, USA) used in this study is a single-piece, monofocal, hydrophobic acrylic IOL based on the AcrySof® platform, but manufactured with a novel copolymer material. This new generation of hydrophobic IOL has been shown to offer excellent optical clarity with minimal glistening formation and low straylight, while preserving the mechanical stability and refractive predictability of its predecessors [28,29,30].

Surgical technique and clinical examination

All procedures were performed under topical anesthesia by experienced anterior segment surgeons using a standardized technique. A self-sealing clear corneal incision (2.4 mm) was made at the 12 o’clock position using a single-bevelled steel blade. Paracentesis was performed at 2–3 o’clock to facilitate surgical manoeuvres. An ophthalmic viscosurgical device (OVD) (ProVisc®, Alcon, USA) was injected into the anterior chamber to maintain space and protect intraocular tissues. A continuous curvilinear capsulorhexis (CCC) was performed using either a cystotome needle or capsulorhexis forceps. CCC was targeted at 5.5 mm to ensure 360° overlap with the 6.0-mm IOL optic, nevertheless intraoperative CCC diameter was not measured [31, 32]. This was followed by standard hydrodissection, phacoemulsification, and irrigation/aspiration of the cortical material. After reinjection of the OVD, an intraocular lens (Clareon® CNA0T0) was implanted into the capsular bag using an automated delivery system (AutonoMe®, Alcon, USA). The orientation of the haptics during implantation was not standardized and was left to the surgeon’s discretion. However, IOL centration was carefully verified at the end of the procedure. Special attention was given to ensuring adequate overlap of the anterior capsulorhexis over the optic edge, in order to promote proper IOL stability. When necessary, centration was fine-tuned by gently manipulating the optic or optic–haptic junction with a Drysdale spatula through the side port. Four follow‑up visits were scheduled at 24 h, 10 days, three weeks and three months postoperatively.

An experienced optometrist (ASL) performed the manifest refraction for the entire subject group and assessed BDCVA using an ETDRS device situated 6 m from the patient. The DCIVA was evaluated using a calibrated test for 40 cm and then recalculated for 60 cm [33]. IOL tilt, decentration, pupil diameter, and pupil position were assessed with anterior segment optical coherence tomography (AS-OCT; CASIA II, Tomey, Nagoya, Japan; software v50.6B.07), a commercially available device for volumetric imaging of the anterior segment. Measurements of IOL tilt and decentration were derived from AS-OCT scans using the device’s standard analysis tools and a device-defined reference axis. A biometrical test was performed using the IOL Master 700 (Carl Zeiss Meditec, AG, Jenna, Germany, version 1.90.33.04) to measure the axial length (AL). Two ophthalmologists took photographs of the capsulorhexis using the slit-lamp, and then those images were analyzed with ImageJ software. Pupil diameter was used to determine the ratio mm/pixel to calculate the area, perimeter, the length of the mayor and minor axis for a fitted ellipse, and a circumference and skewness score [34] for more information see Fig. 1.

Fig. 1
figure 1

Illustrative example of assessing a patient’s capsulorhexis features using imageJ software

Data analysis, conventions and notation

To calculate the correlation avoiding eye laterality bias, we performed the partial correlation considering the covariance of right and left eyes. Prescription data was converted into power vectors notation M, J0 and J45 for analysis of the aggregate data [35]. CASIA II reports the tilt as a positive vector, where the magnitude is the amount of deviation in degrees from the meridional IOL plane (XY plane) and the orientation is referenced to the IOL edge farthest from the cornea. E.g. given a right eye tilt of 5° at 175°, we can assume that the temporal area is more depressed compared to the nasal area. This result can be expressed as −5° at 355°, in this case the negative value indicates that nasal area rises from the meridional IOL plane and the distance to the cornea is shorter. CASIA II expressed the pupil position in Cartesian coordinates (X, Y), we calculate the chord mu length and angle (polar coordinates) using regular mathematical expression for conversion.

To check the normality of the variables we used the Saphiro Wilk. To explore correlation between variables, we conducted a Spearman correlation test (two-sided) setting the statistical threshold in α = 0.05. To compare the components of the vector values, the Wilcoxon test was used. For the data analysis, the software programing language Python (v 3.9.18) using the library Pandas (v 1.5.2) and statistical test was performed using the Pingouin library (v 0.5.4).

Results

A total of 246 eyes (50% right eyes, 50% left eyes) from 123 patients (42% males, 58% females) were assessed, the mean age was 73 ± 8 years old and the follow up period 269 ± 127 days. No adverse events were reported throughout the study. Ocular features derived from the CASIA II and capsulorhexis characteristics are described in Table 1.

Table 1 Postoperative ocular features grouped by corneal and capsulorhexis measurements. The mean keratometry value is denoted by Km, and the anterior chamber depth by ACD

The use of capsular tension rings was not applied in any of the eyes in the sample. Twenty-nine eyes (12%) of the sample showed mild anterior capsular contraction syndrome [36]. The capsulorhexis characterization was available for 141 eyes (58%).

Vision & refraction

The uncorrected monocular distance visual acuity (UDVA) was 0.13 ± 0.13, range [−0.1, 0.6] LogMAR while the monocular BDCVA was 0 ± 0.06 [−0.12, 0.16] LogMAR. Binocular BDCVA was superior to monocular one with a mean of −0.03 ± 0.05 [−0.12, 0.1] LogMAR (p < 0,001). One hundred and fifty-seven eyes (63,82%) achieved monocular BCDVA of 20/20 or better, two hundred and forty eyes (97.56%) had better than 20/25 and the whole sample had better than 20/30. One hundred patients (81.3%) have equal or better binocular vision than 20/20 while the whole study population was equal or better than 20/30. Monocular DCIVA was 0.37 ± 0.12 [−0.02, 0.7] LogMAR and binocular DCIVA was 0.34 ± 0.12 [−0.02, 0.68] LogMAR, this improvement was statistically significant (p < 0.001).

In terms of residual refraction, the mean sphere equivalent (M) was − 0.12 ± 0.38 D and the astigmatism components J0 and J45 were − 0.23 ± 0.26 D and − 0.02 ± 0 0.22 D respectively. The interval distribution of residual M is represented in Fig. 2.

Fig. 2
figure 2

Cumulative intervals of best-corrected and uncorrected vision are shown in the top left and right panels, respectively. In the bottom row, the left panel displays the distribution of residual spherical equivalent by refractive segments, while the right panel shows the cumulative intervals in absolute values

No correlations were found between BDCVA and IOL tilt or IOL decentration, (Spearman test) r = 0.02, 95% CI [−0.11, 0.14], p = 0.78 and r = 0.07, [−0.05, 0.2], p = 0.25 respectively. Similar values were found when testing the correlation between the former variables and DCIVA, for the IOL tilt correlation index was r= −0.11, [−0.23, 0.02], p = 0.10 and for the IOL decentration r=−0.06, [−0.18, 0.07], p = 0.35. BCDVA showed a statistically significant correlation with capsulorhexis area (r=−0.20, [−0.36 −0.04], p = 0.02), perimeter (r=−0.20, [−0.36 −0.03], p = 0.02), mayor axis (r= −0.20, [−0.36 −0.04], p = 0.02) and minor axis (r=−0.19, [-−0.34, 0.02], p = 0.03).

IOL tilt and decentration

The magnitude of the IOL tilt was 5.31 ± 1.42, range [1.3, 11.9] °. For the right eyes, this value was 5.23 ± 1.36 °, while the left eyes showed higher tilt with 5.39 ± 1.48 ° (p = 0.03). Mirror symmetry was found for the IOL tilt, for both eyes the nasal IOL edge was shifted towards the cornea compared to the temporal edge. The IOL tilt frequency distribution was 12 eyes (4.88%) within (0–3] °, 174 eyes (70.73%) within (3–6] °, 58 eyes (23.58%) within (6–9] °, 2 eyes (0.81%) within (9–12] °. The distribution of the two-dimensional tilt vector is represented in Fig. 3.

Fig. 3
figure 3

Double angle vector diagrams for left eyes (left panel), the entire dataset (center panel), and right eyes (right panel), respectively. Each subfigure includes data on the centroid and the 95% confidence ellipse radii

IOL decentration was 0.27 ± 0.16, range [0.03- 1] mm for the whole sample, there was no difference between right and left eyes (p = 0.98), 0.27 ± 0.16 and 0.27 ± 0.15 respectively. The frequency distribution was 168 (68.29%) eyes within (0- 0.3] mm, 66 (26.83%) eyes within (0.30–0.60] mm, 11 (4.47%) eyes within (0.60–0.90] mm, 1 (0.41%) eye within (0.90–1.20] mm. Bivariate analysis for IOL tilt, decentration and pupil position is illustrated in Table 2..

Table 2. Description of the vectorial components (x,y) of the variables with magnitude and direction. The column p-value shows the statistical comparison between left and right eyes, using the Wilcoxon signed ranked test

In one eye of the sample (eye number 6), the temporal haptic of the IOL was positioned over the capsulorhexis. Subsequently, the capsulorhexis features were not measured. The UDVA for that eye was 0.14 LogMAR and the refraction was − 0.25, 0.75 × 95 for a BDCVA − 0.1 LogMAR. For that particular case, the measured IOL tilt was 1.8° at 4° and the IOL decentration was 0.54 mm at 176°.

IOL tilt showed a moderately low correlation with the mu chord distance r = 0.30, [0.18, 0.41], p < 0.001 and with AL r=−0,33, [−0.44, −0.21], p < 0.001. It was also negatively correlated with some capsulorhexis variables such as capsulorhexis perimeter (r=−0.21, [−0.36, −0.04], p = 0.01), area (r=−0.20, [−0.35, −0.04], p = 0.02) and the ellipse axis length (major axis r=−0.21, [−0.36 −0.04], p = 0.02 and minor axis r=−0.19, [−0.34, −0.02], p = 0.03). Contrarily, it was not correlated with the capsulorhexis roundness score r = 0.05, [−0.11, 0.22], p = 0.53 or the skewness of the capsulorhexis r=−0.08, [−0.24, 0.09], p = 0.369. IOL decentration was not statistically significantly correlated with any other variables collected in this study.

Capsulorhexis size and shape

For the features related with the size, the mean area was 25.36 ± 6.42. range [10.03, 40.01] mm2 mean perimeter was 17.87 ± 2.30, [11.31, 22.83] mm, the mean mayor axis was 5.86 ± 0.75 [3.76, 7.30] mm and the minor axis was 5.42 ± 0.74, [3.4, 7.13] mm. Regarding the shape, the mean skewness score was 0.77 ± 0.71, [−1.22, 4.4] and the roundness score was 0.93 ± 0.05, [0.73, 0.99].

Discussion

The IOL model studied here exhibits low values of tilt and decentration in normal patients. There was no correlation between these parameters and the patient’s best corrected visual acuity at distance and intermediate ranges. The aberrations induced by these parameters likely translate into incremental changes in sphero-cylindrical prescriptions. However, the impact of high-order aberrations (spherical or coma), in this context, on visual acuity is likely minimal and can probably be disregarded. Additionally, we used a unique method for characterizing in vivo the area, perimeter, axis, and shape of the capsulorhexis. While the roundness or skewness of the capsulorhexis does not appear to correlate with IOL tilt or decentration, the area, perimeter, and diameter of the capsulorhexis do show a negative correlation with IOL tilt. This tendency suggests that cases with high values of IOL tilt showed low values in the capsulorhexis features, such as perimeter, area and diameter. Furthermore, we explore a singular method to characterize in vivo the area, perimeter, axis and shape of the capsulorhexis. Roundness and skewness of the capsulorhexis were not correlated with IOL tilt or decentration, nevertheless the capsulorhexis area, perimeter or diameter seems to be correlated with the IOL tilt. This idea suggests the capsulorhexis size is more important than shape. Consequently, an expert surgeon performing a manual capsulorhexis should have similar results compared to those performed assisted by femtosecond laser.

The mean IOL tilt and decentration of the CNAOT0 Clareon were consistent with the values reported in the literature [9, 13, 19, 37]. However, we observed higher values in IOL tilt compared to those of Baumeistier et al. [37]likely due to our larger sample size. Schartmüller et al. [13]also reported lower values, but their study involved plate-haptic IOL and capsular tension rings. The IOL tilt and decentration values observed in our study align with the finding from Wang et al. [19]or Veronika et al. [38]who studied IOL with C-loop haptics and had similar sample sizes. Additionally, we observed mirror symmetry between right and left eyes, as shown in Fig. 3.

In this study, the mean capsulorhexis size (5.6 mm) was larger compared to other studies [39,40,41]. Srinivasan set the diameter between 5 and 5.5 mm, although some studies reported larger capsulorhexis sizes [32]. One major concern for large capsulorhexis sizes is the potential association with the development of posterior capsular opacification (PCO), probably because the IOL optical zone is not properly covered [42]. Although the material and the edge design of the IOL also play a significant role, the IOL model used in this study has been associated with low rates of PCO [42]. Another potential issue is that the IOL haptic may be positioned closer to the anterior capsule, as is the case of eye number six of our sample. Consistent with Okada et al. [39]we found no correlation between capsulorhexis roundness and decentration. Although Findl et al. [43] reported high rates of decentration in eyes with severely malformed capsulorhexis, this was not observed in our data.

Several of the previously mentioned studies utilized an OCT device to measure the IOL tilt, but the automatic edge detection in these devices is not always perfect, representing potential limitation of the technic. In contrast, we used CASIA II, which allows for manual adjustment of edge detection and recalculation of the IOL tilt. A key strength of our study is that we manually checked and recalculated every single tomography image to ensure accurate measurements. However, a limitation of our study was the analysis of the capsulorhexis, where only 58% of the sample could be calculated. Difficulties arose due to insufficient mydriatic effect in a way that part of the edge of the capsulorhexis was covered by the iris. Nevertheless, we were able to analyze 141 eyes, which still represents a substantial portion of the sample. Although we cannot fully exclude the possibility of selection bias, there were no relevant differences in biometric parameters or surgical notes between included and excluded cases. This supports the representativeness of the analyzed subgroup.

Our findings indicate no correlation between IOL tilt or decentration and corrected visual acuity, suggesting that these parameters have minimal impact on visual outcomes with the IOL model studied. We also observed favorable visual results in patients implanted with this IOL model. To our knowledge, no prior reports directly correlate capsulorhexis area, perimeter, or principal axis with BCDVA or DCIVA; this statement is based on a PubMed (MEDLINE) search performed at the time of submission using predefined term combinations. Given that IOL tilt is influenced by multiple factors, future work should prospectively collect preoperative crystalline lens metrics, including size, position and tilt, using standardized imaging such as AS-OCT or optical biometry. These variables should then be incorporated into multivariable analyses to quantify their contribution to postoperative IOL tilt. We aim to confirm these findings in a multicenter study to strengthen generalizability.

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

Not applicable.

Funding

This study was supported by an investigation-initiated study grant from Alcon healthcare (IIT#78232309).

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Authors

Contributions

GVR, NAA and MFR designed the study.ASL, LST, LMR and LGO participated in the data collection and clinical examinations.GVR and MFR did the statistical tests.GVR wrote the manuscript.NAA, MFR and LGO reviewed the manuscript.

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Correspondence to Gonzalo Velarde-Rodriguez.

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Ethics approval and consent to participate

This study, which complies with the tenets of the Declaration of Helsinki, was approved by the Research Ethics Committee of the Fundación Jiménez Díaz on September 12, 2023 (reference: PIC204-23-FJD). All participants received and signed an informed consent form prior to their inclusion in the study.

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The authors declare no competing interests.

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Velarde-Rodriguez, G., Garcia-Onrubia, L., Sánchez-Lozano, A. et al. Clinical impact of intraocular lens tilt and decentration: a cross-sectional study. BMC Ophthalmol 25, 585 (2025). https://doi.org/10.1186/s12886-025-04396-y

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