With improvements in intraocular lens (IOL) design and surgical technique, cataract surgery has developed into a form of refractive surgery. Aspheric IOL provides better contrast sensitivity and fewer higher-order aberrations (HOAs) after cataract surgery.1–3 However, malposition of the aspheric IOL in the capsular bag including decentration and tilt can lead to increased HOAs, postoperative glare, halos, and finally worsen visual quality.1,3–6 As premium IOLs such as multifocal IOL, toric IOL, and toric multifocal IOL have gained acceptance, a higher IOL stability is needed to achieve a good visual outcome.7,8

Primary posterior continuous curvilinear capsulorhexis (PPCCC) is widely used in pediatric cataract surgery as a conventional procedure to prevent later obscuration of the visual axis.9 Several studies have also reported that PPCCC was safe and effective in lowering posterior capsule opacification (PCO) in adult cataract surgery and also produced better postoperative refractive stability and IOL centrality.10–14

It has been suggested that IOL–capsule adhesion is crucial to IOL stability, including tilt and decentration, after surgery.15–17 In our previous study, we found that PPCCC resulted in earlier IOL optic–posterior capsule adhesion and better axial stability with implantation of 1-piece 360-degree square-edged hydrophobic IOL.13 At 1 week postoperatively, 71.74% of eyes in the PPCCC group were observed to have complete adhesion between IOL optic and posterior capsule vs 34.78% in the control group. However, few studies have further investigated IOL performance and malposition in the process of capsular reconstruction after cataract surgery with PPCCC, and, to our knowledge, no pair-eye clinical study has assessed IOL tilt, decentration, and consequent visual quality after cataract surgery with PPCCC.12

Currently, Scheimpflug imaging, Purkinje imaging, and OPD-Scan III (Nidek Co., Ltd.) are used to assess IOL position.1,18,19 Among these techniques, OPD-Scan III has the ability to directly provide retroillumination images and optical quality data such as HOAs, modular transfer function (MTF), and point spread function (PSF) at 1 scan, lending convenience and reliability to IOL tilt and decentration measurements.7,18 Using OPD-Scan III, we conducted a prospective randomized intraindividual clinical trial to evaluate IOL tilt and decentration and their effects on optical performance after cataract surgery with and without PPCCC.

METHODS Participants

In this randomized, intraindividual, prospective study, we enrolled 64 eyes of 32 patients with age-related cataract who underwent bilateral cataract surgery between April 2020 and October 2020. The study was conducted at Fujian Provincial Hospital (Fujian, China), was approved by its institutional review board, and was conducted in accordance with the tenets of the Declaration of Helsinki. All potential participants were informed of possible benefits and risks and provided written consent. Inclusion criteria were as follows: (1) a diagnosis of bilateral age-related cataract, (2) corneal astigmatism <1.5 diopters, (3) axial length between 22 mm and 26 mm, (4) implantation of a 1-piece 360-degree square-edge acrylic IOL (TECNIS ZCB00, Abbott Medical Optics, Inc.), (5) and a planned surgical interval of 2 eyes within 1 month. Patients with a history of trauma, uveitis, glaucoma, pseudoexfoliation syndrome, strabismus, dilated pupil diameter <5.0 mm, or previous ocular surgery or laser treatment were excluded. Before enrollment, all patients underwent a series of ophthalmologic examinations including uncorrected distance visual acuity (UDVA; logMAR), slitlamp microscopy, noncontact tonometry, optical biometry, and fundus examination. Some of these data from this cohort were published previously.13 The patients of 2 studies were from the same consecutive patient series but enrolled by different inclusion criteria, where only patients with implantation of the TECNIS ZCB00 IOL in both eyes were enrolled in this study for eliminating the potential effect of IOL design. All data in this study, except for a portion of the demographics and visual acuity, have not been published elsewhere. The data that support the findings of this study are available from the corresponding author on reasonable request.

Randomization

Preoperatively, surgery allocation was achieved when the data analyst randomly selected 1 from the 2 envelopes containing either the PPCCC or NPCCC assignment, which determined the surgical method to be performed on the first operative eye, and the surgical method of the contralateral eye was then determined. Throughout the research study, patients and examiners were masked to treatment assignment, and the surgeon was blinded to the group allocation until surgery commenced.

Surgical Technique

All surgeries were performed by 1 individual (W.J.W.) using a surgical procedure that has been described previously.13 A 2.4 mm temporal clear corneal incision was made using a 2.4 mm keratome. Nuclear removal, cortical aspiration, and posterior capsular polishing were performed within a well-centered 5.5 mm anterior continuous curvilinear capsulorhexis, and subsequent procedures were performed according to group allocation.

In the PPCCC group, the posterior capsule was punctured centrally using a 22-gauge needle to create an approximately 2 mm fissure. Next, an ophthalmic viscosurgical device (sodium hyaluronate 15 mg/mL, Shanghai Qisheng Biological Preparation Co., Ltd.) was injected into the capsular bag. A round and well-centered posterior continuous curvilinear capsulorhexis was then created with a diameter of around 4 mm using the same process for anterior continuous curvilinear capsulorhexis. After the removal of the central capsule flap, a 1-piece 360-degree square-edge acrylic TECNIS ZCB00 IOL was inserted into the capsule bag, and no IOL optic was subluxated through the posterior rhexis. In the NPCCC group, IOL implantation was followed by cataract removal and capsular polishing. The IOL was rotated to be positioned vertically in both groups. Finally, the residual ophthalmic viscosurgical device, including that posterior to the IOL, was aspirated, and incisions were hydrated.

Postoperatively, all patients received routine follow-up at 1 day, 1 week, 1 month, and 3 months. The examinations included UDVA, corrected distance visual acuity (CDVA), auto refractometer, slitlamp microscopy, noncontact tonometry, and OPD-Scan III.

Parameters

IOL tilt, decentration, HOAs, MTF, and PSF were evaluated using OPD-Scan III. Measurements were obtained under dilated pupil greater than 6 mm. In the retroillumination analysis mode, the visual axis position was recorded automatically by the instrument, and the IOL center was identified as the midpoint of the line linking the 2 distal points of its haptics. IOL decentration was determined to be the distance between the IOL center and the visual axis. IOL tilt data were obtained directly from the internal tilt in the wavefront mode. Based on sixth-order Zernike coefficients, both ocular and internal root mean square of HOAs, coma, trefoil, and spherical aberration (SA) were recorded.

MTF and PSF were analyzed in terms of visual quality. The MTF metric was the area ratio value, and the PSF was the Strehl ratio value. For eliminating the effect of the residual mydriatic eyedrop, we analyzed pupil size data at 1 week after surgery. The mean pupil size was 3.2 mm under the photopic condition and 4.6 mm under the mesopic condition. Therefore, all aberrations and visual quality measurements were analyzed at 3 mm and 5 mm pupil size for visual outcomes under photopic and mesopic conditions, respectively.

Statistical Analysis

Descriptive data are presented as mean ± SD. Repeated measures analysis of variance (ANOVA) was used to detect significance within individual participants at different time points. For normal data, between-group difference was determined using the paired t test. For non-normal data, the Mann-Whitney U test was used. Pearson correlation coefficients were calculated for normally distributed data, whereas Spearman correlation coefficients represented non-normal data. All statistical analyses were performed with SPSS (v. 24, SPSS, Inc.). A P value <0.05 was considered statistically significant.

RESULTS Demographic Data and Visual Acuity

During 3 months of follow-up, 4 patients were unable to complete their scheduled follow-ups; the retroillumination images of 2 patients were of poor quality, and IOL decentration could not be calculated. As a result, 52 eyes of 26 patients were available for the final analysis (Figure S1 in the Supplementary Material, https://links.lww.com/JRS/A815). The mean age was 71.96 ± 5.47 years; 7 (26.92%) were male, and 19 (73.08%) were female. There was no significant ocular difference between the 2 study groups in the axial length, IOL power, pupil size, and intraocular pressure (Table 1). During the study, no intraoperative or postoperative complications, including IOL dislocation or subluxation, retinal detachment, or anterior hyaloid rupture, were detected in any eye. The comparison of logMAR CDVA between the 2 groups is depicted in Table 2. There was no difference between the 2 groups in the mean logMAR CDVA at any postoperative follow-up (P > .05, Mann-Whitney U test).

Parameter PPCCC group Mean ± SD NPCCC group Mean ± SD P value n 26 Age (y) 71.96 ± 5.47 PPCCC (left eye/right eye) 11/15 Sex (M/F) 7/19 IOL (D) 21.92 ± 2.20 22.02 ± 1.87 .58 AL (mm) 23.40 ± 0.83 23.38 ± 0.79 .33 Photopic pupil size (mm) 3.23 ± 0.57 3.26 ± 0.33 .85 Mesopic pupil size (mm) 4.55 ± 0.75 4.58 ± 0.42 .89 IOP (mm Hg) 15.54 ± 2.40 16.84 ± 1.87 .05

AL = axial length; NPCCC = no posterior continuous curvilinear capsulorhexis; PPCCC = primary posterior continuous curvilinear capsulorhexis

Table 2. - Visual acuity, IOL tilt, and decentration Parameters PPCCC group Mean ± SD NPCCC group Mean ± SD P value CDVA (logMAR)  1 d 0.05 ± 0.07 0.06 ± 0.10 .86  1 wk 0.04 ± 0.09 0.03 ± 0.09 .91  1 mo 0.03 ± 0.08 0.04 ± 0.08 .59  3 mo 0.03 ± 0.08 0.03 ± 0.07 .87 Overall decentration (mm)  1 d 0.19 ± 0.09 0.25 ± 0.13 .07  1 wk 0.17 ± 0.09 0.22 ± 0.11 .07  1 mo 0.22 ± 0.12 0.26 ± 0.17 .20  3 mo 0.19 ± 0.10 0.30 ± 0.16 <.01* Intraocular tilt (3 mm) (RMS)  1 d 0.11 ± 0.07 0.11 ± 0.08 .92  1 wk 0.09 ± 0.05 0.13 ± 0.11 .10  1 mo 0.09 ± 0.05 0.11 ± 0.07 .26  3 mo 0.09 ± 0.05 0.10 ± 0.05 .63 Intraocular tilt (5 mm) (RMS)  1 d 0.43 ± 0.22 0.39 ± 0.21 .44  1 wk 0.34 ± 0.18 0.47 ± 0.33 .07  1 mo 0.36 ± 0.22 0.36 ± 0.20 .96  3 mo 0.38 ± 0.20 0.41 ± 0.26 .51

NPCCC = no posterior continuous curvilinear capsulorhexis; PPCCC = primary posterior continuous curvilinear capsulorhexis; RMS = root mean square

*Statistically significant

IOL Tilt and Decentration

The box plot shows decentration measurements over time (Figure 1, A). Three months postoperatively, overall IOL decentration remained stable in the PPCCC group (P > .05, repeated measures ANOVA) but significantly increased in the NPCCC group (P < .05, repeated measures ANOVA). The mean overall decentration value was significantly lower in the PPCCC group vs NPCCC group 3 months postoperatively (0.19 ± 0.10 mm vs 0.30 ± 0.16 mm, P < .001, paired t test) (Table 2). However, there was no between-group difference in the overall decentration value at 1 day, 1 week, and 1 month after surgery (P > .05, paired t test). In the NPCCC group, the IOL moved downward during 3 months of follow-up. In the PPCCC group, the IOL moved from an inferonasal to supertemporal direction during 1 month after surgery and returned to the inferonasal position at 3 months (Figure 1, B). There was no obvious tendency of IOL decentration toward each quadrant (Figure 2, A).

Figure 1.:

A: The mean IOL decentration value changes in the PPCCC group and the NPCCC group at 1 day, 1 week, 1 month, and 3 months. B: Mean shift of the IOL centers in the PPCCC group and the NPCCC group over time. NPCCC = no posterior continuous curvilinear capsulorhexis; PPCCC = primary posterior continuous curvilinear capsulorhexis. *Statistically significant

Figure 2.:

A: Distribution of IOL decentration in the PPCCC group and the NPCCC group at 3 months. B: Comparison of the mean internal tilt between the PPCCC group and the NPCCC group at 1 day, 1 week, 1 month, and 3 months. NPCCC = no posterior continuous curvilinear capsulorhexis; PPCCC = primary posterior continuous curvilinear capsulorhexis

Figure 2, B shows the changes in internal tilt in both groups under a 3 mm pupil size. Under both 3 mm and 5 mm pupil, less internal tilt was observed in the PPCCC group at all postoperative visits, although this difference did not reach statistical significance (all P > .05, paired t test and Mann-Whitney U test) (Table 2). Furthermore, no significant change in the internal tilt value was found in either group at all postoperative visits (P > .05, repeated measures ANOVA).

HOAs and Correlation With Tilt and Decentration

Figure 3 provides a between-group comparison of ocular and internal aberrations under a 3 mm and 5 mm pupil size. With respect to internal aberrations, internal SA 1 day after surgery and coma 1 week after surgery were significantly lower in the PPCCC group compared with the NPCCC group under 3 mm pupil (0.15 ± 0.10 μm vs 0.30 ± 0.21 μm, P < .001, Mann-Whitney U test; and 0.34 ± 0.18 μm vs 0.47 ± 0.31 μm, P = .03, paired t test, respectively). In terms of ocular aberrations, no significant between-group difference was found under both 3 mm and 5 mm pupil (all P > .05, paired t test and Mann-Whitney U test).

Figure 3.:

Comparison of the mean ocular (A, C, E, and G) and internal (B, D, F, and H) aberrations between the PPCCC group and the NPCCC group under 3 mm and 5 mm pupil size at 1 day, 1 week, 1 month, and 3 months. NPCCC = no posterior continuous curvilinear capsulorhexis; PPCCC = primary posterior continuous curvilinear capsulorhexis; RMS = root mean square; SA = spherical aberration. * Statistically significant

Under 3 mm pupil, internal tilt was correlated with internal HOAs (R = 0.216, P < .001), internal coma (R = 0.714, P < .001), internal trefoil aberration (R = 0.087, P < .001), and internal SA (R = 0.06307, P = .001). There was no correlation between IOL decentration and any aberration under 3 mm pupil (all P > .05). IOL decentration had a significant correlation with ocular and internal coma (R = 0.083, P < .001, and R = 0.099, P < .001, respectively), ocular and internal SA (R = 0.650, P = .001, and R = 0.613 P = .001, respectively), and internal HOAs (R = 0.418, P = .003) at 5 mm pupil, whereas a significant correlation was found between internal tilt and all aberrations (HOAs, coma, trefoil aberration, and SA), (R = 0.213, R = 0.277, R = 0.764, R = 0.077, and R = 0.072, respectively, all P < .001).

MTF Area Ratio and SRs

At all time points, neither MTF area ratios nor SRs showed a significant difference between the 2 study groups under both 3 mm and 5 mm pupil (all P > .05, paired t test and Mann-Whitney U test) (Figure 4).

Figure 4.:

Comparison of the mean MTF area ratios (A) and Strehl ratios (B) between the PPCCC group and the NPCCC group under 3 mm and 5 mm pupil size at 1 day, 1 week, 1 month, and 3 months. MTF = modulation transfer function; NPCCC = no posterior continuous curvilinear capsulorhexis; PPCCC = primary posterior continuous curvilinear capsulorhexis; RMS = root mean square

DISCUSSION

With the broad application of small-incision phacoemulsification and aspheric IOLs, patients have increased demands for better postoperative visual outcomes. Malposition of the IOL in the capsular bag, such as decentration and tilt, can impair visual quality.1,4,7 Furthermore, the visual quality of sophisticated IOLs, such as multifocal IOL and toric multifocal IOL, is more sensitive to IOL malposition, which requires high stability to preserve a good visual outcome after surgery.6,7 In our previous study, we found earlier optic-posterior capsular adhesion and good axial stability in eyes with PPCCC.13 Therefore, we proposed that PPCCC might provide better IOL centration to lessen aberrations and improve visual quality. In this prospective intraindividual study, we evaluated IOL tilt and decentration and their effects on HOAs after cataract surgery with and without PPCCC based on a 1-piece 360-degree square-edge acrylic IOL, which might become the most popular design mode of the premium IOL in the future.

Traditionally, IOL decentration is measured more frequently using Scheimpflug photography or Purkinje imaging, in which the pupillary axis is made as reference.19,20 However, these methods are influenced by angle κ.19 According to the study by Harrer et al., even if angle κ was in the average range, more HOAs were observed in eyes due to the discrepancy between the pupil axis and the visual axis.21 In our study, we used the visual axis and IOL geometric center to identify IOL decentration with OPD-Scan III, which can detect IOL malposition and reveal its influence on visual quality.7,22 Furthermore, less human factors were involved in our measurements because our methods do not require the use of image-processing software, which is needed for the Scheimpflug and Purkinje methods.22 In addition, OPD-Scan III can provide IOL tilt, HOAs, and optical quality data directly at a single scan, simplifying the examination procedure. Compared with other methods, OPD-Scan III was more accurate and comprehensive when studying both IOL position and visual quality.7,18

In our study, the overall decentration value in the PPCCC group was more stable at the 3-month visit. Theoretically, myofibroblastic transformation of residual lens epithelial cells (LECs) is obviated when the IOL optic is in firm contact with the residual posterior capsule, blocking the process of capsular fibrosis.23–25 Given our previous results that observed an earlier and firmer adhesion between the IOL optic and the posterior capsule in PPCCC eyes, we conjecture that PPCCC may lead to better IOL stability resulting from the earlier and firm capsule–IOL complex formation.13 Similarly, Kim et al. pointed out that IOL displacement attributable to capsular contraction was reduced when cataract surgery involved PPCCC; however, in contrast with our results, no significant between-group difference in IOL decentration was found.12 It should be noted that Kim's study was not intraindividual, and IOL decentration was evaluated with respect to the pupil and limbus, which limited its validity. Furthermore, the 2 studies used differing IOL designs, which might also contribute to this discrepancy.

Several studies have analyzed the movement of IOL decentration over time.12,26 In this study, the IOL centers in the PPCCC group showed a tendency to shift from inferonasal to supertemporal decentration during 1 month after surgery and then returned to the inferonasal direction at 3 months, as also reported by Kim et al.12 In their study, IOL movement was driven by capsular fibrosis and shrinkage of the capsulorhexis opening, consistent with the study by Ding et al.26 With faster adhesion, remnant LECs are minimally exposed to cytokines in the aqueous humor, inhibiting consequent epithelial–mesenchymal transition, thus capsular fibrosis and shrinkage.17,27,28 Therefore, lower decentration values in the PPCCC group might be due to weakened capsular fibrosis because of faster adhesion between the optic and capsule. However, more mechanical proofs are still needed to support this assumption.

In the NPCCC group, the IOL moved downward during 3 months of follow-up, which was also observed by Zhu et al.18 In their study, inferior IOL decentration was observed in both emmetropic and myopic eyes. They suggested that larger inferior decentration values in myopic eyes might be related to their relatively larger capsular bag. Therefore, the slight sink of the IOL in our study might be attributed to the pull of gravity, as well as the incompatibility between the capsular bag and IOL in the NPCCC group.

Incomplete IOL optic adhesion is considered a causative factor in IOL tilt.26 Although differences in internal tilt values in the 2 groups did not reach statistical significance, the mean internal tilt values under 3 mm pupil in the PPCCC group were generally lower than in the NPCCC group. We also found that internal tilt stabilized in the PPCCC group 1 week postoperatively, whereas stability did not occur in the NPCCC group until 1 month after surgery. These findings are consistent with our previous study, in which 71.74% of eyes attained 360-degree optic–posterior capsule adhesion in the PPCCC group at 1 week after surgery vs 34.78% in the NPCCC group.13 Likewise, Zhu et al. also found that 32% of eyes with implantation of the ZCB00 IOL achieved posterior capsule adhesion at 1 week, which increased to nearly 80% at 1 month.29 Thus, we hypothesized that stability of IOL tilt values in PPCCC might be also contributed to earlier optic–posterior capsule adhesion.

The optical performance of the IOL is closely related to its centrality after surgery.1,6,7 In this study, IOL decentration correlated with ocular and internal coma, ocular and internal SA, and internal HOAs under 5 mm pupil, in agreement with the study by Lawu et al.1 In the present study, PPCCC resulted in decreased internal SA 1 day postoperatively and internal coma 1 week postoperatively under 3 mm pupil, which might indicate better visual outcomes in the early postoperative phase under a photopic lighting condition. However, either MTF area ratio or Strehl ratio showed no significant difference between the 2 groups. According to the study by Tandogan et al., the MTF area ratio of the aspheric IOL was decreased by 10% when the IOL decentration exceeded 1 mm.8 In our study, the maximum decentration value in the 2 groups was 0.56 mm, which was obviously less than the critical level. Therefore, no significant degradation of visual quality in eyes with the aspheric IOL design was anticipated. However, in those eyes with the sophisticated IOL optic design, the postoperative visual quality was more sensitive to tilt and decentration.6,7 An IOL decentration of 0.5 to 0.75 mm could lead to a significant reduction of the MTF area ratio for multifocal IOLs.8 Although postoperative visual quality did not differ between the 2 groups with monofocal aspheric IOLs, equal decentration values might significantly reduce the optical performance of multifocal IOLs. Further studies with multifocal IOLs may be beneficial.

The biggest strength of this study is the prospective, double-blinded randomized controlled intraindividual study design, which offers optimal comparability and validity to this study. However, there are still some potential limitations to this study. First, the population enrolled in this study was relatively small, so a randomized multicenter study with a large sample may be necessary to confirm our findings. Second, it is an inherent limitation that PPCCC could not be blind for the surgeon during the operation. Given that the surgeon did not participate in the subsequent examination and data analysis, a minor possibility of bias might exist in the randomization. In addition, the intraindividual study design may still help to minimize the risk of bias. Finally, we chose the time point of 3 months based on the outcomes of our previous study, where it was observed that posterior capsule–optic adhesion was well formed in most eyes in either the PPCCC group (100%) or the NPCCC group (96%) at 3 months after surgery.13 However, a longer follow-up should be performed for exploring the long-term performance.

In conclusion, less IOL decentration was observed in PPCCC eyes at 3 months after surgery, indicating that PPCCC may result in better IOL centrality. Considering the additional advantages including the tolerance for PCO, better axial stability, and thus better refractive predictability, PPCCC could be regarded as a promising option for cataract surgery. Studies with a longer follow-up time and more types of IOL are needed to assess the long-term effect of PPCCC and its impact on premium IOLs.WHAT WAS KNOWN Primary posterior continuous curvilinear capsulorhexis (PPCCC) is effective and safe in adult cataract surgery to prevent later obscuration of the visual axis. PPCCC could result in earlier IOL optic–posterior capsule adhesion and better axial stability with implantation of a 1-piece 360-degree square-edged hydrophobic IOL.

WHAT THIS PAPER ADDS Using OPD-Scan III, better IOL centrality and less HOAs were observed in eyes after cataract surgery with PPCCC during 3-month follow-up. Acknowledgments

The authors thank Caron Modeas for editorial assistance.

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