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Observational Study
. 2024 Nov;262(11):3661-3670.
doi: 10.1007/s00417-024-06508-8. Epub 2024 May 21.

Intermediate-term impact on corneal endothelial cells and efficacy of Preserflo MicroShunt implantation in patients with open-angle glaucoma - a prospective study over two years

Caroline J Gassel  1 , Daniel A Wenzel  2 , Emil Nasyrov  2 , Torsten Strasser  2   3 , Bogomil Voykov  2
Affiliations
Observational Study

Intermediate-term impact on corneal endothelial cells and efficacy of Preserflo MicroShunt implantation in patients with open-angle glaucoma - a prospective study over two years

Caroline J Gassel et al. Graefes Arch Clin Exp Ophthalmol. 2024 Nov.

Abstract

Introduction: Preserflo MicroShunt is a novel microinvasive bleb forming device for the treatment of primary open-angle glaucoma. The intermediate- and long-term success and the impact of this procedure on corneal endothelial cell density remain to be investigated.

Methods: In this prospective observational study, 62 eyes of 55 glaucoma patients (mean age ± SD: 67.0 ± 15.0 years) receiving a Preserflo MicroShunt were included. Corneal endothelial cell density, intraocular pressure and best corrected visual acuity were assessed preoperatively and at 3, 6, 9, 12, 18 and 24 months postoperatively. Success rates, bleb revision rates and complications were analysed. Complete success was defined as an intraocular pressure reduction of ≥ 20% and achieving a target pressure of ≤ 18, ≤ 15 or ≤ 12 mmHg without antiglaucoma medication. Qualified success indicated that the criteria were reached with or without medication.

Results: Corneal endothelial cells showed no significant decline over 24 months (p > 0.05). Intraocular pressure showed a substantial reduction postoperatively (p < 0.001), decreasing from 29.6 ± 8,3 mmHg to 13.0 ± 4.3 mmHg after 24 months (p < 0.001). Complete and qualified success with a target pressure ≤ 15 mmHg was achieved in 52.9% and 54.6% of cases after 24 months, respectively. Best corrected visual acuity did not change after 24 months.

Conclusion: Preserflo MicroShunt had no negative side effects on corneal endothelial cells and showed favourable success rates after 2 years in patients with open-angle glaucoma.

Keywords: Corneal endothelial cells; Glaucoma surgery; Microinvasive bleb surgery; Open-angle glaucoma; Preserflo MicroShunt.

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Conflict of interest statement

Declarations. The study adhered to the principles of the Declaration of Helsinki of 1964. Prior to surgery, all patients provided informed consent, along with additional written consent for study participation. Ethical approval was granted by the local institutional ethics committee of the University of Tübingen (project number: 037/2021BO2). Conflict of interest: CG, DW, EN and TS certify that they have no affiliations with or involvement in any organization or entity with any financial interest, or non-financial interest in the subject matter or materials discussed in this manuscript. BV has received speaker honoraria and advisory board compensation fees from AbbVie Deutschland GmbH, Novartis and Santen GmbH.

Figures

Fig. 1
Fig. 1
Scatterplot of IOP values preoperatively vs 12 months and 24 months after PMS implantation, respectively. Cut-off IOP levels of ≤ 12 mmHg, ≤ 15 mmHg and ≤ 18 mmHg are depicted. The grey dotted line marks no change in IOP pre- to postoperatively. The grey solid line indicates a 20% reduction in IOP
Fig. 2
Fig. 2
Mean and SD BCVA at all study follow-up time points
Fig. 3
Fig. 3
Boxplots showing median, first quartile, third quartile, minimum and maximum ECD at baseline and 3, 6, 9, 12, 18 and 24 months after PMS implantation. The mean values are shown graphically as a line. Differences were not statistically significant
Fig. 4
Fig. 4
Kaplan–Meier survival plot illustrating the probability of success after PMS implantation in the entire study population. The probabilities of “complete success” and “qualified success” with a target IOP ≤ 18 mmHg (a), ≤ 15 mmHg (b), and ≤ 12 mmHg (c) are shown
Fig. 5
Fig. 5
Kaplan–Meier survival plots illustrating the probability of success after PMS implantation for eyes with “previous surgery” and eyes with “no previous surgery”. a, c and e display the probabilities of “complete success” which was defined as an IOP reduction of ≥ 20% and achievement of the respective target IOP without IOP-lowering medication. b, d and f display the probabilities of “qualified success” with the respective target IOP. The survival probabilities with a target IOP ≤ 18 mmHg, ≤ 15 mmHg and ≤ 12 mmHg are shown. Differences were not statistically significant (p > 0.05)
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