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Introduction <p>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).</p> Methods <p>One-piece high-water-content IOLs (Clareon® SY60WF; group&#xa0;C) and control hydrophobic acrylic IOLs (Vivinex XY1; group&#xa0;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&#xa0;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&#xa0;mm area were counted using a slit-lamp microscope. Surface light scattering was evaluated using densitometry. Finally, outcomes were compared among the groups.</p> Results <p>Overall, 116 eyes were compared (58 eyes each in groups&#xa0;C and V). No differences in the CDVA, contrast sensitivity, and MVs were observed between the groups. The mean densitometry value in group&#xa0;C was significantly higher (<i>P</i> = 0.027) than in group&#xa0;V, increasing significantly from the values recorded at 1–4&#xa0;weeks, although the change was clinically small (0.29%).</p> Conclusion <p>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.</p> Trial Registration <p>Registered in the Japan Registry for Clinical Trials (identifier jRCTs032190093).</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月15日

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  • Akira Miyata,
  • Kazunori Miyata,
  • Keiichiro Minami

摘要

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).