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Twelve-month efficacy and safety of glaucoma filtration device for surgery in patients with normal-tension glaucoma

  • Clinical Investigation
  • Published:
Japanese Journal of Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To assess the efficacy and safety of filtration surgery using the EX-PRESS glaucoma filtration device in patients with normal-tension glaucoma (NTG).

Study design

Prospective, single-arm, multicenter interventional case series.

Methods

Eyes with NTG underwent EX-PRESS implantation with or without cataract surgery. The efficacy and safety were assessed at 1 day; 1 and 2 weeks; and 1, 3, 6, and 12 months after surgery. The main outcome measure was reduction in intraocular pressure (IOP) from baseline at 3, 6, and 12 months after surgery. Safety assessments included adverse event incidence, postoperative inflammation, and corneal endothelial cell density.

Results

Thirty-two Japanese patients (37 eyes) with NTG were enrolled. The mean IOP decreased from 14.8 ± 2.3 mmHg at baseline to 10.0 ± 3.1 mmHg at 12 months after surgery (mean reduction 4.9 ± 4.2 mmHg [31.1%]; P < .0001). IOP-lowering medication use decreased from a mean of 3.3 medications per eye before surgery to 0.1 medications per eye at 12 months after surgery. IOP reductions > 20% were achieved by 61.5% of the eyes at 12 months. Adverse events were typical for filtration procedures, and none was deemed device-related. Postoperative inflammation was mild and self-limiting. The mean corneal endothelial cell density had decreased by 3.3% at 12 months after surgery.

Conclusion

The EX-PRESS glaucoma filtration device is safe and effective for filtration surgery in patients with NTG, providing mean IOP reduction consistent with recommendations based on the Collaborative NTG Study.

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Author information

Authors and Affiliations

  1. Department of Ophthalmology, University of Tokyo School of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Makoto Aihara

  2. Fukushima Eye Clinic, Fukushima, Japan

    Yasuaki Kuwayama

  3. Miyata Ophthalmic Hospital, Miyazaki, Japan

    Kazunori Miyata

  4. Kagoshima Miyata Eye Clinic, Kagoshima, Japan

    Shinichiro Ohtani

  5. Ideta Eye Hospital, Kumamoto, Japan

    Ryuichi Ideta

  6. Shinseikai Toyama Hospital, Toyama, Japan

    Yoshihiro Hashimoto

  7. Alcon Japan, Tokyo, Japan

    Noriyuki Sasaki

  8. Yotsuya-Shirato Eye Clinic, Tokyo, Japan

    Shiroaki Shirato

Authors
  1. Makoto Aihara
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  2. Yasuaki Kuwayama
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  3. Kazunori Miyata
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  4. Shinichiro Ohtani
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  5. Ryuichi Ideta
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  6. Yoshihiro Hashimoto
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  7. Noriyuki Sasaki
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  8. Shiroaki Shirato
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Corresponding author

Correspondence to Makoto Aihara.

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Conflicts of interest

M. Aihara, Research fee (Alcon), Support for Study design/Manuscript preparation/ Statistical analysis (Alcon), Financial support (Alcon Pharma, AMO, CREWT medical systems, Glaukos, Kowa Pharmaceutical, Nitten, Novartis, Ono, Otsuka, Pfizer, Santen, Senju, TOMEY, Wakamoto), Consultant fee (Alcon Pharma, CREWT medical systems, Glaukos, HOYA, InnFocus, Iridex, Kowa, Ono, Otsuka, Pfizer, Santen, Senju, Wakamoto), Lecture fee (Alcon Pharma, AMO Japan, Canon, Carl Zeiss Meditec, CREWT medical systems, Glaukos, HOYA, InnFocus, Iridex, Ivantis, Kowa Pharmaceutical, NIDEK, Nitten, Novartis, Ono, Otsuka, Pfizer, Santen, Senju, TOMEY, Alcon), Travel fee (Alcon Pharma, AMO Japan, Canon, Carl Zeiss Meditec, CREWT medical systems, Glaukos, HOYA, InnFocus, Iridex, Ivantis, Kowa Pharmaceutical, NIDEK, Nitten, Novartis, Ono, Otsuka, Pfizer, Santen, Senju, TOMEY) Grant (Alcon); Y. Kuwayama, Research fee (Alcon), Lecture fee (Alcon Pharma, Glaukos Japan, Kowa, Otsuka, Pfizer, Santen, Senju), Consultant fee (Kowa, Otsuka, Pfizer, Santen, Senju, Aerie Pharmaceuticals, Wakamoto); K. Miyata, Research fee (Alcon), Lecture Fee (Alcon, AMO, HOYA, Senju, Santen, Wakamoto, Kowa, Otsuka, Chuosangio, TOMEY, Staar), Grant (AMO, HOYA, Senju, Shionogi, Santen, Novartis, Wakamoto, Kissei, Sucampo Pharma); S. Ohtani, Research fee (Alcon) ; R. Ideta, Lecture fee (Alcon Pharma, Otsuka, Pfizer, Santen, Wakamoto); Y. Hashimoto, None; N. Sasaki, Employee (Alcon); S. Shirato, Research fee (Alcon), Lecture fee (Alcon).

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Corresponding author: Makoto Aihara

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Aihara, M., Kuwayama, Y., Miyata, K. et al. Twelve-month efficacy and safety of glaucoma filtration device for surgery in patients with normal-tension glaucoma. Jpn J Ophthalmol 63, 402–409 (2019). https://doi.org/10.1007/s10384-019-00682-7

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  • DOI: https://doi.org/10.1007/s10384-019-00682-7

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