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

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-11-22 DOI:10.1007/s40123-024-01074-y

Nora Majtanova, Adriana Takacova, Veronika Kurilova, Libor Hejsek, Juraj Majtan, Petr Kolar

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引用次数: 0

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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PreserFlo MicroShunt 使用腱膜下注射与海绵注射丝裂霉素 C 一年后的疗效和安全性比较。

简介本研究旨在比较通过腱膜下注射丝裂霉素 C（MMC）植入 PreserFlo 微分流术（PMS）与通过浸泡过 MMC 的海绵进行传统植入的疗效和安全性：这项为期 1 年的回顾性队列研究纳入了 100 名青光眼患者的 100 只眼睛，他们都接受了 PMS 植入术，并通过腱膜下注射（50 只眼睛）或浸泡海绵（50 只眼睛）使用了丝裂霉素 C（0.4 毫克/毫升）。1年的主要结果是眼压降低，完全成功的定义是眼压降低≥20%，并在不使用药物的情况下达到目标眼压≤21或18 mmHg。对包括角膜内皮细胞密度（CECD）损失、用药次数和并发症在内的次要结果进行了评估和组间比较：结果：在为期一年的随访中，两组患者的平均眼压均持续下降，组间无显著差异。1年后目标眼压≤21 mmHg的完全成功率，海绵组为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 21 mmHg 时，注射组的存活率高于海绵组。CECD 平均值明显降低（P腱膜下注射 MMC 的 PMS 植入术在疗效和安全性方面与传统的通过浸泡海绵输送 MMC 的方法相当。不过，注射组的成功率明显高于海绵组。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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