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Effects of kallidinogenase in patients undergoing vitrectomy for diabetic macular edema

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Abstract

Purpose

To evaluate the effectiveness of the combination of vitrectomy with kallidinogenase for diabetic macular edema (DME).

Methods

This study was designed as a prospective, randomized, multicenter study comparing 19 eyes of 19 patients who received 150 units of kallidinogenase administered a day for 52 weeks from the day after vitrectomy (study group) with 20 eyes of 20 patients who received no kallidinogenase (control group). The main outcome measurements included logMAR visual acuity and central foveal thickness (CFT) before surgery and at 3, 6, 9, and 12 months after vitrectomy.

Results

During follow-up, 11 patients dropped out (six in the study group and five in the control group), leaving 28 eyes in 28 patients for analysis (13 in the study group and 15 in the control group). Visual acuity improved significantly at 12 months in both groups compared with before surgery. The degree of improvement did not differ significantly between the groups. At 12 months, the mean CFT decreased significantly in both groups, with no significant difference in the rate of change between the two groups. In the study group, the visual acuity and CFT significantly improved from 3 to 12 months and from 6 to 12 months, whereas these parameters did not continue to improve in the control group after 6 months (for visual acuity) or 3 months (for CFT).

Conclusion

After vitrectomy for DME, visual acuity and CFT improved significantly in both groups, but only patients treated with kallidinogenase continued to have significant improvement throughout the study period.

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Acknowledgements

The authors would like to thank Enago (www.enago.jp) for the English language review.

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Authors and Affiliations

  1. Department of Ophthalmology, Saneikai Tsukazaki Hospital, 68-1 Aboshiku Waku, Himeji, 671-1227, Japan

    Yuki Yoshizumi, Zaigen Ohara, Hitoshi Tabuchi, Hitomi Sumino & Yukiko Maeda

  2. Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan

    Yuki Yoshizumi, Zaigen Ohara, Hideki Mochizuki, Ken Yamane & Yoshiaki Kiuchi

Authors
  1. Yuki Yoshizumi
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Corresponding author

Correspondence to Yuki Yoshizumi.

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The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Yoshizumi, Y., Ohara, Z., Tabuchi, H. et al. Effects of kallidinogenase in patients undergoing vitrectomy for diabetic macular edema. Int Ophthalmol 39, 1307–1313 (2019). https://doi.org/10.1007/s10792-018-0945-8

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  • DOI: https://doi.org/10.1007/s10792-018-0945-8

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