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Long-Term Clarity of High-Water-Content Hydrophobic Acrylic Intraocular Lens: A 3-Year Randomized Comparison with a Hydrophobic Lens of Similar Material and Design

  • Open Access
  • 15.05.2025
  • ORIGINAL RESEARCH
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Abstract

Introduction

This randomized prospective study aimed to quantitatively evaluate 3-year visual function, glistenings, and surface light scattering following the implantation of high-water-content hydrophobic acrylic intraocular lenses (IOLs).

Methods

One-piece high-water-content IOLs (Clareon® SY60WF; group C) and control hydrophobic acrylic IOLs (Vivinex XY1; group V) were randomly implanted in 120 Japanese participants (120 eyes). Subsequently, the corrected distance visual acuity (CDVA), contrast sensitivity, glistening-derived microvacuoles (MVs), and surface light scattering were examined up to 3 years postoperatively. EPCO software was used to confirm the absence of postoperative capsule opacification to ensure that it did not influence the outcomes. MVs within a 15 × 4 mm area were counted using a slit-lamp microscope. Surface light scattering was evaluated using densitometry. Finally, outcomes were compared among the groups.

Results

Overall, 116 eyes were compared (58 eyes each in groups C and V). No differences in the CDVA, contrast sensitivity, and MVs were observed between the groups. The mean densitometry value in group C was significantly higher (P = 0.027) than in group V, increasing significantly from the values recorded at 1–4 weeks, although the change was clinically small (0.29%).

Conclusion

This randomized comparative study confirmed non-inferiority in visual function of eyes with Clareon IOLs. A 3-year comparison indicated no difference in glistening suppression, CDVA, or contrast sensitivity, whereas a slight increase was observed in surface light scattering.

Trial Registration

Registered in the Japan Registry for Clinical Trials (identifier jRCTs032190093).
Prior Presentation: The 42nd Congress of the European Society of Cataract and Refractive Surgeons, Barcelona, September 2024.
Key Summary Points
Why carry out this study?
Sustaining the clarity of implanted hydrophobic acrylic intraocular lenses (IOLs) is important. The clarity of eyes with high-water-content hydrophobic acrylic IOLs (Clareon® Alcon, Fort Worth, TX) was examined, and their clinical performance was evaluated for 1–3 years postoperatively.
No quantitative evaluation of glistening and surface light scattering has been reported. Although glistenings have been assessed using a grading system, more precise and quantitative measures of glistening-derived microvacuoles (MVs) are required for evaluating concurrent IOLs.
Comparison with one-piece hydrophobic acrylic IOLs of similar materials, fabrication, and design under randomized assignment is desirable for fair evaluation.
What was learned from the study?
In this 3-year randomized prospective study involving quantitative evaluation of corrected distance visual acuity, numbers of MVs, surface light scattering, and contrast sensitivity, no differences were observed in corrected distance visual acuity, glistenings, and contrast sensitivity in eyes with high-water-content hydrophobic acrylic IOL.
At 3 years postoperatively, surface light scattering increased, and the impact on visual function was smaller than that of predecessor IOLs.

Introduction

Optical clarity of implanted intraocular lenses (IOLs) is a critical determinant of visual quality following cataract surgery [1]. IOL clarity may be degraded by inhomogeneities on the IOL surface and within the bulk material, including surface haze caused by roughness [1, 2], glistenings caused by microvacuoles (MVs) [3], and surface light scattering [4, 5] due to subsurface nano-glistenings (SSNG) [6, 7]. Sustaining IOL clarity over long postoperative periods is desirable. Although such inhomogeneities have been observed during postoperative slit-lamp examinations, their prominent impacts on visual function remain rare [6].
Glistenings are MVs that form within voids of hydrophobic acrylic material [3, 6, 8]. They typically appear at approximately 3 months postoperatively and remain stable for up to 3 years. Surface light scattering has been observed in a particular hydrophobic acrylic IOL manufactured using the cast-molding process [1, 7, 9]. Nanometer-sized water aggregates form within the surface layer of the IOL, leading to surface light scattering. An increase in surface light scattering is observed after 3 years or later, with the intensity progressively rising over time.
The Clareon® SY60WF (Alcon, Fort Worth, TX) is an innovative lens made from a hydrophobic acrylic material in which hydroxyethyl methacrylate (HEMA) is used instead of phenylethyl methacrylate. Consequently, the water content increases, which resists the glistening formation [3]. Furthermore, using an improved cast-molding process, SSNG formation can be suppressed [9]. Experimental verification has confirmed the transparency of the Clareon® material [1]. Clinical evaluations of eyes with Clareon monofocal IOLs demonstrated a reduction in glistenings and surface light scattering [1013]. However, long-term evaluations for 3 years are limited [14, 15], although such degradations typically occur in 2–3 years or later. A 3-year multinational cohort study of Clareon® monofocal IOLs [14] assessed postoperative corrected distance visual acuity (CDVA) as well as glistenings using Miyata’s gradings [16]. For IOLs resistant to glistenings [14], a more precise and quantitative measure of MV development is required. Additionally, a quantitative and fair comparison of the newly developed IOL with similar hydrophobic acrylic IOLs is essential.
This randomized prospective study aimed to evaluate long-term IOL clarity in eyes with Clareon® SY60WF for 3 years postoperatively, compared with one-piece hydrophobic acrylic IOLs of similar materials, fabrication, and design (Vivinex® XY1, Hoya, Tokyo, Japan).

Methods

Participants

The study protocol was approved by the SHOWA University Clinical Research Review Board as a specified clinical trial and registered in the Japan Registry for Clinical Trials (jRCTs032190093; https://jrct.niph.go.jp/latest-detail/jRCTs032190093). Written informed consent was obtained from each patient. The study adhered to the tenets of the Declaration of Helsinki and Clinical Trials Act (Act No. 16 of April 14, 2017) of Japan. Written informed consent was obtained from each patient.
In total, 120 patients with senile cataracts were recruited from two sites. The inclusion criteria were IOL implantation in capsules, no disease influencing postoperative vision except for cataract, anticipated postoperative CDVA of 20/25 (0.097 logMAR) or better, and age ≥ 20 years. The exclusion criteria were eye diseases such as uveitis, retinal detachment, iris neovascularization, and corneal degeneration; a history of ocular surgery such as corneal surgery and IOL implantation; and requirement of complicated surgery due to zonular rupture, posterior capsule rupture, vitreous prolapse, and hyphema.

Sample Size

The primary endpoint of this long-term study was to examine the non-inferiority of changes in CDVA from 1–4 weeks to 3 years postoperatively compared with those of control IOLs. To detect the difference in CDVA change between the IOLs with a margin of 0.2 logMAR (corresponding to two steps in the Landolt chart), 23 eyes per group were required for a significance level of 0.05 and detection power of 0.85, with an expected standard deviation (SD) of 0.3 logMAR for CDVA [17]. Similarly, for detecting non-inferiority in CDVA at 3 years postoperatively, 32 eyes were required. Considering the rate of eyes achieving 20/25 (0.097 logMAR) or better (approximately 95%) CDVA, assuming a 30% dropout rate during the 3 years, the total sample size was determined to be 120 eyes (120 participants).

Intraocular Lenses and Implantation

Table 1 shows the properties of the materials of implanted IOLs. Clareon® SY60WF is a one-piece hydrophobic acrylic IOL with an optic diameter of 6 mm and a length of 13 mm, provided with an automated preload delivery system (CNA0T0). Its water content is relatively high (1.5% at 35 °C), with the lower glass transition temperature and the posterior edge designed as a sharp rectangle. A one-piece hydrophobic acrylic IOL (XY1) of similar materials and design with the same optical diameter and length and a sharp posterior edge was used as a control. Both IOLs were fabricated using a cast-molding process and yellow-tinted to suppress blue light transmittance. The posterior surface of the XY1 IOL was modified with active oxygen to facilitate biological adhesion [18]. Previous evaluations of XY1 have reported the superior resistance to MV formation and posterior capsule opacification (PCO) suppression compared with AcrySof® IOLs (Alcon Laboratories) [8, 19].
Table 1
Properties of materials and haptics of implanted IOLs
 
Group C
Group V
IOL
Clareon® SY60WF (Alcon)
Vivinex® XY1 (Hoya)
Fabrication
Cast-molding
Cast-moulding
Material
Hydrophobic acrylic: copolymer of PEA and HEMA, cross-linked with butanediol diacrylate
Hydrophobic acrylic: cross-linked copolymer of PEMA and n-butyl acrylate and fluoroalkyl methacrylate, with UV-ozone surface modification
Glass transition temperature
9.1 °C
11 °C
Water content
1.5%
0.7%
Color
Yellow tinted
Yellow tinted
PEA 2-phenylethyl acrylate, HEMA 2-hydroxyethyl methacrylate, PEMA 2-phenylethyl methacrylate UV ultra violet
The participants were randomly assigned to receive either SY60WF IOLs (group C) or XY1 IOLs (group V) based on a randomized table generated using the randomizer package Ver.0.22.0 of R Ver 4.0.1 immediately after enrollment.
Preoperative examinations included the assessment of patient demographics, CDVA, corneal endothelial cell density, and conducting slit-lamp microscopy to eliminate anterior segment abnormalities. The IOL power calculation formula was not specified but was the same as that routinely used at each site. The target refraction was unspecified. After cataract removal via conventional phacoemulsification and aspiration, IOLs were implanted in capsules using injectors specified for the implanted IOLs.

Postoperative Examinations

CDVA was assessed at 1–4 weeks, 6 months, and 1, 2, and 3 years postoperatively using a Landolt ring chart at 5 m, with results converted to the logarithm of the minimum angle of resolution (logMAR) for analysis. To evaluate the influence of IOL clarity only, eyes with PCO were excluded using the Evaluation of Posterior Capsular Opacification (EPCO) 2000 system [20]. Eyes that underwent YAG (yttrium aluminum garnet) posterior capsulotomy during the observation period were excluded.
Glistening formation was evaluated at 6 months and thereafter. The number of MVs was assumed to be less than the lowest level of conventional severity grading (25 MV/mm2) [16]. Therefore, the number of MVs in the center IOL area under slit illumination of 15-mm width, 4-mm length, and 30° angle (corresponding to the area of 51.9 mm2) was counted after mydriasis. Notably, each MV was small and difficult to capture in an image; therefore, the MVs were identified and counted by the physicians (Fig. 1).
Fig. 1
MVs (yellow arrow) observed in the central intraocular lens area under 15 × 4 mm slit illumination
Bild vergrößern
Surface light scattering was evaluated at all visit points, except at 6 months, through densitometry [21]. After mydriasis, a perpendicular image was obtained using a rotating Scheimpflug camera (Pentacam) or its higher-definition model (Pentacam HR, both Oculus Optikgerät GmbH, Wetzlar, Germany). Densitometry of the central anterior IOL surface within a 3-mm diameter and 0.25-mm height was measured (area value, %). Densitometric values calculated using the Pentacam HR were converted to those measured using the Pentacam on the basis of the regression equation previously obtained [22].
Contrast sensitivity was examined at 1 and 3 years postoperatively using an Optec6500 (Stereo Optics, Chicago, IL) system. After distance correction, the contrast sensitivity for spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd) was examined using photopic (85 cd/m2) and mesopic (3.0 cd/m2) illumination with and without glare. Area under contrast sensitivity function (AULSCF) [23] was also calculated for comparing between the groups.

Statistical Analysis

The primary endpoint was the non-inferiority of group C in CDVA change from 1–4 weeks to 3 years postoperatively. Eyes with a CDVA of 20/25 or better at 1–4 weeks and without YAG posterior capsulotomy were selected for analysis. After no difference in the CDVA between the groups at 1–4 weeks postoperatively was confirmed, the non-inferiority of group C at 3 years was examined within a margin of 0.15 logMAR. The non-inferiority of changes in CDVA from 1–4 weeks to 3 years was also examined within a margin of 0.20 logMAR.
Opacification in the retroillumination images was blindly identified. The entire capsulotomy or pupil areas for eyes in older Japanese patients [24] with insufficient mydriasis were identified. Difference in CDVA at 1, 2, and 3 years postoperatively in eyes with no PCO was examined using the Mann–Whitney U test.
The secondary endpoints included glistenings, surface light scattering, and contrast sensitivity. For glistenings, the increase in MVs from 6 months was examined using the Kruskal–Wallis test. MVs at 3 years were compared between the groups. For surface light scattering, increases in densitometry values from 1–4 weeks were examined using the Kruskal–Wallis test, followed by the Dunnett multiple comparison. The degradations at each spatial frequency from 1 to 3 years postoperatively were analyzed using a t test with Holm multiple comparison for contrast sensitivities. Differences between the groups were also examined. The contrast sensitivity of eyes with no PCO at 3 years postoperatively was compared between the groups. Statistical significance was set at P < 0.05.

Results

This study enrolled 120 patients (120 eyes). Four patients (four eyes) dropped out before or during surgery (change in the implanted IOL). Subsequently, 116 participants were eligible for analysis, including 58 eyes each in groups C and V. The mean ages of the groups C and V were 70.9 (SD 7.6) and 71.2 (SD 7.7), respectively, with no significant differences (P = 0.87, t test). The ratio of men and women was 25/33 and 22/36, with no differences (P = 0.54, chi-squared test). All IOLs were implanted in the capsule and completely covered the anterior capsule at the end of the surgery. No intraocular or postoperative complications were reported. The changes in the number of participants from enrollment until the 3-year follow-up are summarized in Fig. 2.
Fig. 2
Changes in participant numbers from enrollment until 3-year follow-up
Bild vergrößern

Visual Acuity

The number of eyes examined at 6 months and 1, 2, and 3 years postoperatively was 56, 56, 55, and 53 in group C and 58, 58, 56, and 55 in group V, respectively. Table 2 lists the mean CDVA at each visiting time, with no differences between the groups (P > 0.44, Mann–Whitney U test). Figure 3 illustrates the distributions of uncorrected distance visual acuity (UDVA), CDVA, manifest refraction spherical equivalent (MRSE), and refractive cylinder at 3 years postoperatively [25]. The mean MRSE and refractive cylinder values were − 0.37 (SD 0.85) and 0.82 (SD 0.61) D in group C and − 0.75 (SD 1.25) and 0.74 (SD 0.52) D in group V, respectively. No differences were observed between the groups (P = 0.06 and 0.49, unpaired t test). The UDVA of group C was slightly better than that of group V owing to a higher rate of emmetropic MRSE.
Table 2
Postoperative mean corrected distance visual acuity, logMAR
 
Group C (IOL: SY60WF)
Group V (IOL: XY1)
P value*
1–4 weeks
− 0.08 (SD 0.08)
− 0.08 (SD 0.09)
0.97
6 months
− 0.08 (SD 0.08)
− 0.08 (SD 0.08)
0.68
1 year
− 0.08 (SD 0.08)
− 0.08 (SD 0.07)
0.82
2 years
− 0.07 (SD 0.09)
− 0.09 (SD 0.07)
0.44
3 years
− 0.06 (SD 0.10)
− 0.07 (SD 0.09)
0.65
logMAR logarithm of the minimum angle of resolution, IOL intraocular lens, SD standard deviation
*Mann–Whitney U test
Fig. 3
Cumulative percentage of eyes achieving monocular uncorrected (UDVA) and corrected (CDVA) distance visual acuities (top), and distributions of manifest refraction spherical equivalent (middle) and postoperative refractive cylinder (bottom) in groups C and V
Bild vergrößern
The primary endpoint was examined in 100 eyes (50 eyes each in both groups). Specifically, CDVA for four eyes was worse than 20/25 at 1–4 weeks, and six eyes (three in each group) had undergone YAG posterior capsulotomy. At 1–4 weeks postoperatively, the mean logMAR CDVAs were − 0.08 (SD 0.07) and − 0.09 (SD 0.06) in groups C and V, respectively, with no significant difference (P = 0.38, Mann–Whitney U test). The mean and 95% confidence interval (95% CI) values at 3 years were − 0.067 (95% CI − 0.094, 0.040) and − 0.087 (95% CI − 0.103, − 0.071) in groups C and V, respectively. The non-inferiority of group C was verified within a margin of 0.15 logMAR (P < 0.001). Between 1–4 weeks and 3 years, the mean change was 0.01 logMAR in both groups, with no significant difference with a margin of 0.2 logMAR (P = 0.44, t test).
Eyes with no PCO were examined between groups C and V. At 2 years postoperatively, 28 and 24 eyes were assessed, and the mean CDVA was − 0.080 and − 0.096 logMAR, respectively. At 3 years, CDVAs of − 0.065 and − 0.086 logMAR were obtained from 12 and 16 eyes, respectively. No significant differences between the groups were observed for both years (P = 0.97 and 0.78).

Glistenings

MVs were observed in six, five, six, and six eyes at 6 months and 1, 2, and 3 years postoperatively, respectively. No significant change was observed from 6 months onward (P = 0.99, the Kruskal–Wallis test). The maximum numbers of MVs observed at 1 year postoperatively were three in 3 of 56 eyes of group C and two in 2 of 58 eyes of group V. Meanwhile, three MVs in 3 of 53 eyes of group C and four MVs in 3 of 55 eyes of group D were observed at 3 years postoperatively. Four MVs corresponded to a density of 0.077 MVs/mm2. No differences in the number of eyes with MVs (P > 0.68, Fisher’s exact test) and the number of MVs (P = 0.60, Mann–Whitney U test) were observed between the groups.

Surface Light Scattering

Densitometry analysis was performed in 58, 56, 55, and 53 eyes at 1–4 weeks and 1, 2, and 3 years postoperatively in group C and 58, 58, 56, and 56 eyes in group V, respectively. Figure 4 shows the mean densitometry values at 1, 2, and 3 years. Although group V showed no significant change over time (P = 0.50, analysis of variance), group C exhibited a significant increase in densitometry between 1–4 weeks and 3 years (P = 0.027, Dunnett’s test for multiple comparisons). Densitometry values at 3 years were significantly higher in group C (P = 0.027, unpaired t test) than in group V, with the mean difference of 0.28%.
Fig. 4
Boxplots of densitometry values indicating surface light scattering on the anterior intraocular lens surfaces in groups C and V. Black diamond denotes mean values. A significant increase was observed in group C at 3-year follow-up (P = 0.027, Dunnett test for multiple comparisons)
Bild vergrößern

Contrast Sensitivity

Photopic and mesopic contrast sensitivity was examined in 113 eyes (55 eyes in group C and 58 eyes in group V) at 1 year and in 105 eyes (51 eyes in group C and 54 in group V) at 3 years. Figure 5 shows the mean logarithmic contrast sensitivities at 3 years postoperatively. No significant differences under photopic and mesopic conditions with and without glare were observed in any spatial frequencies (P > 0.09, t test).
Fig. 5
Mean logarithm contrast sensitivities under photopic (left) and mesopic (right) conditions without and with glare (top and bottom, respectively) 3 years postoperatively of eyes implanted with SY60WF (group C) and XY1 (group V)
Bild vergrößern
Changes from 1 to 3 years were evaluated in the eyes included in the primary endpoint (49 eyes per group). The differences between 1 and 3 years postoperatively were calculated and compared between the groups. No significant difference was observed between the groups (P > 0.21; unpaired t test with Holm’s correction).
For eyes without PCO at 3 years postoperatively (n = 11 and 15 for groups C and V, respectively), no difference was observed in AULCSF between the groups (P > 0.48, Mann–Whitney U test).

Discussion

In this randomized observational 3-year study, the CDVA of group C was not inferior to that of group V at 3 years. Furthermore, no differences were observed in glistenings and contrast sensitivity between the two groups. However, slight increases in surface light scattering due to SSNG were observed at 3 years in group C. Notably, previous clinical evaluations have reported no changes in CDVA and glistenings until 1 year postoperatively [1013]. Table 3 lists previous 3-year randomized and intra-individual observational studies of Clareon and Vivinex IOLs. Aligning with our results, these previous studies reported no differences in CDVA between the two IOL types. Although the evaluation methods for glistenings varied among studies, the occurrence and number of MVs observed were low for both IOL types. Furthermore, our results revealed a lesser number of MVs but high resistance to glistening formation, consistent with previous studies [1, 8]. The increase in surface light scattering of group C has been reported previously [26]. Whereas, to our knowledge, contrast sensitivity of eyes with Clareon IOLs until 3 years postoperatively has not been evaluated.
Table 3
Comparison of 3-year outcomes with the previous studies
Study
IOL
N, eyes/patients
Mean CVDA, logMAR
Glistenings
Nuijts et al. [14]
AcrySof SY60WF
365/183
− 0.032 (SD 0.1137)
All eyes: grade 0a
Leydolt et al. [15]
Clareon CNA0T0
67/67
− 0.03 (SD 0.08)
2 Eyes: < 10–20 MVs in 20 mm2
Vivinex XY1
67/67
− 0.03 (SD 0.08)
9 Eyes: < 20–30 MVs in 20 mm2
Current
Clareon SY60WF
53/53
− 0.06 (SD 0.10)
All eyes: grade 0a
3 Eyes: 1–3 MVs in 51.9 mm2
Vivinex XY1
55/55
− 0.07 (SD 0.09)
All eyes: grade 0a
3 Eyes: 1–4 MVs in 51.9 mm2
IOL intraocular lens, CDVA corrected distance visual acuity, logMAR logarithm of the minimum angle of resolution, SD standard deviation, MV microvacuole
aMiyata’s grade [16]
A slight increase in surface light scattering was observed at 3 years postoperatively in group C, whereas it was reduced by the continuous improvement of the cast-molding process [7]. The current increase between 2 and 3 years postoperatively was 0.13%, similar to the results observed in eyes implanted with the same IOLs with a similar production process [26]. Compared with the increased surface light scattering observed using the AcrySof IOL, surface light scattering was suppressed in the Clareon IOL. However, further investigation is essential to explore the long-term effects associated with the continued use of the current Clareon IOLs.
In the sub-analysis, the influence of IOL clarity was investigated. Visual acuity and contrast sensitivity decrease with PCO, even if PCO development is relatively low [15]. CDVA and contrast sensitivity were analyzed after excluding eyes with any opacification on the posterior IOL surface to avoid such an influence. No differences were observed in the postoperative CDVA and contrast sensitivity between the groups, demonstrating the clarity of the two IOL types. Although the surface light scattering due to SSNG increased in group C, no influences were observed on CDVA and contrast sensitivity at 3-year postoperatively, highlighting that SSNG did not affect visual function. However, further investigation is warranted.
MV formation is associated with the changes in water content [3], and higher water content could resist MV formation. Hence, we anticipated that hydrophobic acrylic material containing hydrophilic polymer such as HEMA would effectively suppress MV formation. MVs normally increase until 3 years; therefore, examinations conducted only within the first year [1013] would be insufficient, and evaluations extending over 3 years are necessary. As observed in experimental studies, Clareon IOLs exhibited the least glistenings [1]. Both the current and previous [15] precise evaluations demonstrated the higher resistance of Clareon IOLs.
The MVs resulting from glistenings are too small, making conventional Miyata’s grading [16] insufficient. More precise grading was developed, where the number of MVs under slit-lamp illumination in a 10 × 2 mm area is counted and graded as follows: < 10, 10–20, 20–30, 30–40, and > 40 corresponding to trace, 1+, 2+, 3+, and 4+, respectively [27]. This grading has been used in a previous study [15]. For evaluating glistenings of current IOLs, counting MVs is necessary for precise assessment.
This study also has some limitations. First, the observation period was insufficient to investigate the impact of SSNG. While SY60WF was manufactured in the predecessor production process, Kinoshita et al. demonstrated the increase in SSNG until 7 years after implantation [26]. The risk of visual function degradation due to increased surface light scattering is likely to be higher after 12 years postoperatively. Second, differences in MRSE existed between the groups, although participants were randomly assigned. This difference of 0.38 D was attributed to the target refraction of emmetropia and slight myopia. Although the ratios of target refractions were occasionally equal, this factor is unlikely to have affected the outcomes, as the current study examined CDVA and contrast sensitivity.

Conclusion

This randomized comparative study quantitatively evaluated the clarity of Clareon IOLs and their influence on long-term visual function. In a 3-year comparison between SY60WF and XY1 IOLs, our findings revealed no differences in the suppression of glistening, CDVA, or contrast sensitivity, although a slight difference was observed in the increase of the SSNG.

Acknowledgements

We thank the participants of the study and Dr. Satoshi Kato for support with the PCO analysis using EPCO software without any financial assistance.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have approved the published version of the manuscript.

Declarations

Conflict of Interest

Akira Miyata reports speaker honorarium from Alcon. Kazunori Miyata reports speaker honorarium from Alcon and Hoya. Keiichiro Minami reports no competing interests.

Ethical Approval

This investigator-initiated study was approved by the SHOWA University Clinical Research Review Board and registered in the Japan Registry for Clinical Trials (jRCTs032190093; https://jrct.niph.go.jp/latest-detail/jRCTs032190093). The study was conducted in accordance with the tenets of the Declaration of Helsinki and the Clinical Trials Act of Japan (Act No. 16, 2017). Written informed consent was obtained from each patient.
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Titel
Long-Term Clarity of High-Water-Content Hydrophobic Acrylic Intraocular Lens: A 3-Year Randomized Comparison with a Hydrophobic Lens of Similar Material and Design
Verfasst von
Akira Miyata
Kazunori Miyata
Keiichiro Minami
Publikationsdatum
15.05.2025
Verlag
Springer Healthcare
Erschienen in
Ophthalmology and Therapy / Ausgabe 7/2025
Print ISSN: 2193-8245
Elektronische ISSN: 2193-6528
DOI
https://doi.org/10.1007/s40123-025-01165-4
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