Abstract
Purpose
To evaluate the long-term safety and effectiveness of the Preserflo MicroShunt in Japanese primary open-angle glaucoma (POAG) patients.
Study design
Single-site, nonrandomized observational study.
Patients and methods
Eight eyes of 7 POAG patients were included. The surgical complications and interventions were monitored. The preoperative and postoperative intraocular pressures (IOPs), numbers of antiglaucoma medications, logarithm of the minimum angle of resolution visual acuity (VA), mean deviation (MD) slope, and corneal endothelial cell density (CECD) were compared retrospectively.
Results
The mean follow-up period was 68.9 months (range, 48–76 months). The baseline IOP of 17.9 ± 3.5 mmHg and the number of glaucoma medications of 3.5 ± 0.5 were significantly reduced at subsequent follow-up visits. At 1, 2, 3, 4, 5, and 6 years postoperatively, the IOPs were 13.8 ± 2.9, 12.8 ± 2.3, 12.1 ± 3.2, 12.6 ± 2.5, 12.3 ± 1.0, and 13.5 ± 3.1 mmHg, respectively, with the use of 1.6 ± 1.4, 1.6 ± 1.6, 1.5 ± 1.4, 1.5 ± 1.4, 1.9 ± 1.3, and 2.0 ± 1.1 medications. Postoperative transient hyphema occurred in 1 eye. Postoperative needling was required in 5 eyes, 12 times in total. No eyes showed significant VA decline, except for 1 eye with a severe central visual field defect that existed preoperatively. The preoperative MD slope of − 1.6 ± 1.2 dB/year improved significantly, to − 0.3 ± 0.2 dB/year (P = 0.023), postoperatively. The baseline CECD decreased from 2595 ± 292 to 2478.4 ± 255 postoperatively.
Conclusion
The microshunt surgical procedure is safe and effective for Japanese POAG patients.
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Acknowledgements
This work was supported by the Japan Society for the Promotion of Science (JSPS), grant number 19K09965 (to M.H.) and Kakenhi grant number 20H03839 (to M.A.). The sponsor or funding organization had no role in the design of this research nor in how the research was conducted. The Preserflo MicroShunt was provided without financial compensation by InnFocus MicroShunt (Santen).
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T. Ahmed, None; M. Honjo, None; R. Sakata, None; T. Fujishiro, None; S. Shirato, None; M. Aihara, None.
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Ahmed, T., Honjo, M., Sakata, R. et al. Long-term results of the safety and effectiveness of a novel microshunt in Japanese patients with primary open-angle glaucoma. Jpn J Ophthalmol 66, 33–40 (2022). https://doi.org/10.1007/s10384-021-00893-x
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DOI: https://doi.org/10.1007/s10384-021-00893-x