Majtanova Nora, Takacova Adriana, Kurilova Veronika, Hejsek Libor, Majtan Juraj, Kolar Petr
Department of Ophthalmology, Slovak Medical University and University Hospital in Bratislava, Antolska 11, 851 07, Bratislava, Slovakia.
Department of Ophthalmology, Faculty of Medicine in Hradec Kralove, Charles University and University Hospital Hradec Kralove, 500 05, Hradec Kralove, Czech Republic.
Ophthalmol Ther. 2025 Jan;14(1):153-167. doi: 10.1007/s40123-024-01074-y. Epub 2024 Nov 22.
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.
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.
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.
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.
本研究旨在比较PreserFlo微型分流器（PMS）植入联合丝裂霉素C（MMC）经球结膜下注射与传统MMC浸泡海绵应用的疗效和安全性。
这项回顾性的1年队列研究纳入了100例青光眼患者的100只眼睛，这些患者接受了PMS植入联合MMC（0.4mg/ml）治疗，MMC通过球结膜下注射（50只眼）或浸泡海绵（50只眼）给药。1年时的主要结局指标是眼压降低，完全成功定义为眼压降低≥20%且在不使用药物的情况下达到目标眼压≤21或18mmHg。评估并比较两组的次要结局，包括角膜内皮细胞密度（CECD）损失、用药数量和并发症。
在1年的随访中，两组平均眼压均持续降低，两组间无显著差异。1年后目标眼压≤21mmHg时，海绵组的完全成功率为19.3%，注射组为26.4%。海绵组和注射组的合格成功率分别为59.0%和87.4%。当眼压低于21mmHg时，注射组的生存率高于海绵组。两组从基线到术后各随访时间点，平均CECD均显著降低（P<0.01）。术后1年，海绵组CECD总损失百分比为8.1%，注射组为8.0%。然而，两组间平均CECD值、用药数量或不良事件无显著差异。
PMS植入联合球结膜下注射MMC在疗效和安全性方面与传统MMC浸泡海绵给药相当。然而，注射组的成功率显著高于海绵组。
