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Mid-term real world outcomes of the Hydrus® Microstent in open angle glaucoma

Eye (2024)Cite this article

Subjects

Abstract

Purpose

To evaluate the mid-term clinical results and the safety aspects of the Hydrus® Microstent (Ivantis, Inc, Irvine, CA) in a real-life setting.

Design

Retrospective case series.

Methods

Hydrus® Microstent was implanted in phakic eyes (88 eyes, 87.1%) and in pseudophakic eyes (13 eyes, 12.9%), respectively. Mean follow-up time was 16 ± 9 months with 27 eyes having a follow-up time of more than 24 months.

Main outcome measures

The primary endpoint was reduction in IOP compared to baseline. Target IOP levels were set at ≤20 mmHg, ≤18 mmHg and ≤15 mmHg. Kaplan–Meier survival was defined as a reduction in IOP of ≥20% compared to baseline. Secondary endpoints were reduction in number of glaucoma medications and safety assessments addressing visual acuity, adverse events, re-surgery rate and identification of factors that made the implantation more difficult.

Result

101 eyes underwent Hydrus® implantation. The mean preoperative IOP was 21.60 mmHg (SD 6.6) on 2.18 (SD 1.3) medications. After a mean follow up time of 16 months, the mean IOP was reduced to 14.61 ± 3.7 mmHg on 1.12 (SD 1.1) medication classes (p < 0.001). Mean decrease in IOP was 26.7%. Analysis of the target IOP levels showed that in 29%, 34% and 35% of cases an IOP of ≤15 mmHg, ≤18 mmHg and ≤20 mmHg respectively could be achieved. BCVA improved from 0.56 ± 0.3 at baseline to 0.85 ± 0.3 more than 24 months after surgery (p < 0.001). The rate of re-operation was low at <3%. Adverse events occurred in 4 eyes (<4%).

Conclusion

This study underlines the effectiveness and the safety of the Hydrus® Microstent in an elective setting, but it also demonstrates certain limits and risk factors of this procedure.

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Fig. 1: Average medicated IOP development.
Fig. 2: Kaplan Meier curves on IOP.
Fig. 3: IOP in phacic and pseudohacic eyes.

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Data availability

The data that support the findings of this study are available on request from the corresponding author V. Prokosch. The data are not publicly available due to privacy restrictions.

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Funding

Ivantis, Inc. provided the Hydrus® Microstent devices used free of charge. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Author information

Author notes

  1. These authors contributed equally: Katrin Lorenz, Verena Prokosch.

Authors and Affiliations

  1. Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany

    David Kiramira, Urs Voßmerbäumer, Norbert Pfeiffer, Katrin Lorenz & Verena Prokosch

  2. Department of Periodontology and Operative Dentistry, University Medical Center, Johannes Gutenberg-University, Mainz, Germany

    David Kiramira & Lea K. M. Linnerth-Braun

  3. Frankfurt Hoechst Eye Hospital, Frankfurt, Germany

    Urs Voßmerbäumer

  4. Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany

    Verena Prokosch

Authors
  1. David Kiramira
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  5. Katrin Lorenz
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Contributions

DK, KL and VP conceived and designed the analysis and wrote the paper. DK and LL-B performed the analysis. VP, UV and NP contributed data.

Corresponding author

Correspondence to Verena Prokosch.

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Competing interests

The data from this study were made available to Ivantis Inc. before the publication. However, no restrictions from the manufacturer were exerted nor accepted concerning the manuscript body.

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Kiramira, D., Voßmerbäumer, U., Pfeiffer, N. et al. Mid-term real world outcomes of the Hydrus® Microstent in open angle glaucoma. Eye (2024). https://doi.org/10.1038/s41433-023-02920-2

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