One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge

Abstract Introduction This study was performed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) applied by sub-tenon injection versus conventional application by MMC-soaked sponges. Methods This retrospective, 1-year cohort study included 100 eyes...

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Main Authors: Nora Majtanova, Adriana Takacova, Veronika Kurilova, Libor Hejsek, Juraj Majtan, Petr Kolar
Format: Article
Language:English
Published: Adis, Springer Healthcare 2024-11-01
Series:Ophthalmology and Therapy
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Online Access:https://doi.org/10.1007/s40123-024-01074-y
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author Nora Majtanova
Adriana Takacova
Veronika Kurilova
Libor Hejsek
Juraj Majtan
Petr Kolar
author_facet Nora Majtanova
Adriana Takacova
Veronika Kurilova
Libor Hejsek
Juraj Majtan
Petr Kolar
author_sort Nora Majtanova
collection DOAJ
description Abstract Introduction This study was performed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) applied by sub-tenon injection versus conventional application by MMC-soaked sponges. Methods This retrospective, 1-year cohort study included 100 eyes of 100 patients with glaucoma who underwent PMS implantation with MMC (0.4 mg/ml) delivered either by sub-tenon injection (50 eyes) or via soaked sponges (50 eyes). The primary outcome measure at 1 year was intraocular pressure (IOP) reduction, with complete success defined as an IOP reduction of ≥ 20% and achieving a target IOP of ≤ 21 or 18 mmHg without the use of medication. Secondary outcomes, including corneal endothelial cell density (CECD) loss, the number of medications, and complications, were assessed and compared between the groups. Results Sustained reductions in mean IOP were observed in both groups over the 1-year follow-up, with no significant differences between the groups. The complete success rate, with a target IOP of ≤ 21 mmHg after 1 year, was 19.3% in the sponge group and 26.4% in the injection group. The qualified success rate was 59.0% and 87.4% in the sponge and injection groups, respectively. A longer survival rate was observed in the injection group than in the sponge group when IOP was below 21 mmHg. The mean CECD significantly decreased (P < 0.01) from baseline to each postoperative follow-up time point in both groups. At 1 year postoperatively, the percentage of total CECD loss was 8.1% in the sponge group and 8.0% in the injection group. However, no significant differences in mean CECD values, the number of medications, or adverse events were found between the groups. Conclusions PMS implantation with sub-tenon injection of MMC was comparable in terms of efficacy and safety to traditional MMC delivery via soaked sponges. However, the injection group demonstrated a significantly higher success rate than the sponge group.
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spelling doaj-art-11a1da50e64c4a83bb5020e2e9fdc6c42025-01-12T12:10:43ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282024-11-0114115316710.1007/s40123-024-01074-yOne-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus SpongeNora Majtanova0Adriana Takacova1Veronika Kurilova2Libor Hejsek3Juraj Majtan4Petr Kolar5Department of Ophthalmology, Slovak Medical University and University Hospital in BratislavaDepartment of Ophthalmology, Slovak Medical University and University Hospital in BratislavaDepartment of Ophthalmology, Slovak Medical University and University Hospital in BratislavaDepartment of Ophthalmology, Faculty of Medicine in Hradec Kralove, Charles University and University Hospital Hradec KraloveInstitute of Molecular Biology, Slovak Academy of SciencesDepartment of Ophthalmology, Slovak Medical University and University Hospital in BratislavaAbstract Introduction This study was performed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) applied by sub-tenon injection versus conventional application by MMC-soaked sponges. Methods This retrospective, 1-year cohort study included 100 eyes of 100 patients with glaucoma who underwent PMS implantation with MMC (0.4 mg/ml) delivered either by sub-tenon injection (50 eyes) or via soaked sponges (50 eyes). The primary outcome measure at 1 year was intraocular pressure (IOP) reduction, with complete success defined as an IOP reduction of ≥ 20% and achieving a target IOP of ≤ 21 or 18 mmHg without the use of medication. Secondary outcomes, including corneal endothelial cell density (CECD) loss, the number of medications, and complications, were assessed and compared between the groups. Results Sustained reductions in mean IOP were observed in both groups over the 1-year follow-up, with no significant differences between the groups. The complete success rate, with a target IOP of ≤ 21 mmHg after 1 year, was 19.3% in the sponge group and 26.4% in the injection group. The qualified success rate was 59.0% and 87.4% in the sponge and injection groups, respectively. A longer survival rate was observed in the injection group than in the sponge group when IOP was below 21 mmHg. The mean CECD significantly decreased (P < 0.01) from baseline to each postoperative follow-up time point in both groups. At 1 year postoperatively, the percentage of total CECD loss was 8.1% in the sponge group and 8.0% in the injection group. However, no significant differences in mean CECD values, the number of medications, or adverse events were found between the groups. Conclusions PMS implantation with sub-tenon injection of MMC was comparable in terms of efficacy and safety to traditional MMC delivery via soaked sponges. However, the injection group demonstrated a significantly higher success rate than the sponge group.https://doi.org/10.1007/s40123-024-01074-yGlaucomaGlaucoma surgeryMIBSIntraocular pressureCorneal endothelial cells
spellingShingle Nora Majtanova
Adriana Takacova
Veronika Kurilova
Libor Hejsek
Juraj Majtan
Petr Kolar
One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge
Ophthalmology and Therapy
Glaucoma
Glaucoma surgery
MIBS
Intraocular pressure
Corneal endothelial cells
title One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge
title_full One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge
title_fullStr One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge
title_full_unstemmed One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge
title_short One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge
title_sort one year comparison of efficacy and safety of preserflo microshunt with mitomycin c applied by sub tenon injection versus sponge
topic Glaucoma
Glaucoma surgery
MIBS
Intraocular pressure
Corneal endothelial cells
url https://doi.org/10.1007/s40123-024-01074-y
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