Purpose

To investigate the efficacy and safety of a newly developed pinhole soft contact lens (Eyelike Pinhole II; Koryo Eyetech Co. Ltd.) for presbyopia correction.

Methods

This prospective clinical study enrolled 29 patients with presbyopia between October 2018 and December 2018. All participants wore the Eyelike Pinhole II in the non-dominant eye for >3 h/day for a period of 1 week. Binocular and monocular uncorrected near visual acuities, distance-corrected near visual acuity (DCNVA), uncorrected distance visual acuity, and corrected distance visual acuity (CDVA) were measured before and after the intervention. All visual acuities were measured in logarithm of the minimal angle of resolution (logMAR) units. In addition, binocular defocus curves were generated, and contrast sensitivity values were obtained under photopic and mesopic conditions before and after lens wear.

Results

The mean DCNVA of the treated eye and the mean binocular DCNVA improved from 0.34 ± 0.12 to 0.15 ± 0.14 (P < 0.001) and 0.31 ± 0.13 to 0.11 ± 0.10 (P < 0.001) logMAR, respectively, after pinhole contact lens wear. Although the mean CDVA of the treated eye deteriorated from −0.04 ± 0.05 to 0.02 ± 0.11 logMAR (P = 0.015), there was no significant change in the mean binocular CDVA (P = 0.79). The binocular defocus curve showed a significant improvement from −5.0 dioptres (D) to −1.0 D after pinhole contact lens wear.

Conclusions

The newly developed Eyelike Pinhole II soft contact lens showed safe and effective outcomes; thus, it could be a promising option for the treatment of presbyopia.

中文翻译：

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一种新型小孔径矫正老花眼软性隐形眼镜的临床结果。

目的

研究新开发的针孔软性隐形眼镜（Eyelike Pinhole II；Koryo Eyetech Co. Ltd.）用于矫正老花眼的功效和安全性。

方法

这项前瞻性临床研究在 2018 年 10 月至 2018 年 12 月期间招募了 29 名老花眼患者。 所有参与者在非优势眼中佩戴 Eyelike Pinhole II 超过 3 小时/天，持续 1 周。干预前后分别测量双眼和单眼未矫正近视力、远距矫正近视力（DCNVA）、未矫正远视力和矫正远视力（CDVA）。所有视力均以最小分辨率角 (logMAR) 单位的对数进行测量。此外，还生成了双眼散焦曲线，并在镜片佩戴前后获得了明视和中视条件下的对比敏感度值。

结果

佩戴针孔隐形眼镜后，治疗眼的平均 DCNVA 和平均双眼 DCNVA 从 0.34 ± 0.12 改善至 0.15 ± 0.14 (P < 0.001) 和 0.31 ± 0.13 至 0.11 ± 0.10 (P < 0.001) logMAR。尽管治疗眼的平均 CDVA 从 -0.04 ± 0.05 恶化到 0.02 ± 0.11 logMAR (P = 0.015)，但平均双眼 CDVA (P = 0.79) 没有显着变化。佩戴针孔隐形眼镜后，双眼散焦曲线显示出从 -5.0 屈光度 (D) 到 -1.0 D 的显着改善。

结论

新开发的 Eyelike Pinhole II 软性隐形眼镜安全有效；因此，它可能是治疗老花眼的一个有希望的选择。