Lin Tong, Wang Wushuang, Lu Yang, Gong Lan
Department of Ophthalmology, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.
NHC Key Laboratory of Myopia (Fudan University), Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China.
Front Med (Lausanne). 2021 Nov 18;8:769448. doi: 10.3389/fmed.2021.769448. eCollection 2021.
Punctal/intracanalicular plugs on the market nowadays are all designed before clinical use in treating dry eye disease (DED). To provide an individualized lacrimal drainage system occlusion method and reduce the complications, we developed a "liquid plug" strategy by intracanalicular injection of hydroxybutyl chitosan (HBC) solution, a thermosensitive, phase-changing biomaterial. This study evaluated the efficacy and safety of the HBC plug in treating dry eye disease by comparing it with the VisiPlug absorbable intracanalicular plug. A monocenter, randomized, controlled clinical trial was performed. Fifty patients with DED were randomized 1:1 to undergo either the HBC injection treatment or the VisiPlug treatment. Ocular Surface Disease Index (OSDI) questionnaire, tear break-up time (TBUT), corneal fluorescence staining (CFS), tear meniscus height (TMH), and phenol red thread test were evaluated at Day 0 (baseline, before treatment) and Weeks 1, 4, and 12. The two groups had a balanced baseline of age, gender, and DED-related characteristics. Both occlusion methods could relieve the symptoms and signs of DED. Significant improvement was found in OSDI, phenol red thread test, and tear meniscus height ( < 0.05 compared to baseline) but not in corneal fluorescence staining and tear break-up time ( > 0.05). There is no statistically significant difference between HBC injection and VisiPlug at Weeks 1 and 4 ( > 0.05). However, at week 12, the HBC injection was not as effective as the VisiPlug in maintaining phenol red thread test (HBC: 5.35 ± 3.22 mm, VisiPlug: 8.59 ± 4.35 mm, = 0.009) and tear meniscus height (HBC: 206.9 ± 47.95 μm, VisiPlug: 242.59 ± 60.30 μm, = 0.041). The numbers of ocular adverse events were relatively low in both groups. The HBC injection showed similar efficacy and safety compared to VisiPlug. The intracanalicular injection of HBC solution proves to be a promising, individualizing method to treat DED. This study is registered with the Chinese Clinical Trial Registry (https://www.chictr.org.cn/enindex.aspx), Identifier: ChiCTR1800016603.
目前市面上的泪点/泪小管栓子都是在临床用于治疗干眼症（DED）之前设计的。为了提供一种个性化的泪液引流系统阻塞方法并减少并发症，我们开发了一种“液体栓子”策略，即通过泪小管注射羟丁基壳聚糖（HBC）溶液，这是一种热敏性、相变生物材料。本研究通过将HBC栓子与VisiPlug可吸收泪小管栓子进行比较，评估了HBC栓子治疗干眼症的疗效和安全性。进行了一项单中心、随机、对照临床试验。50例干眼症患者按1:1随机分组，分别接受HBC注射治疗或VisiPlug治疗。在第0天（基线，治疗前）以及第1、4和12周评估眼表疾病指数（OSDI）问卷、泪膜破裂时间（TBUT）、角膜荧光素染色（CFS）、泪河高度（TMH）和酚红棉线试验。两组在年龄、性别和与DED相关的特征方面基线均衡。两种阻塞方法均可缓解DED的症状和体征。OSDI、酚红棉线试验和泪河高度均有显著改善（与基线相比<0.05），但角膜荧光素染色和泪膜破裂时间无显著改善（>0.05）。在第1周和第4周，HBC注射与VisiPlug之间无统计学显著差异（>0.05）。然而，在第12周，HBC注射在维持酚红棉线试验（HBC：5.35±3.22mm，VisiPlug：8.59±4.35mm，P = 0.009）和泪河高度（HBC：206.9±47.95μm，VisiPlug：242.59±60.30μm，P = 0.041）方面不如VisiPlug有效。两组眼部不良事件的数量相对较少。与VisiPlug相比，HBC注射显示出相似的疗效和安全性。泪小管注射HBC溶液被证明是一种有前景且个性化的治疗DED的方法。本研究已在中国临床试验注册中心（https://www.chictr.org.cn/enindex.aspx）注册，标识符：ChiCTR1800016603。
