Scarinci Fabio, De Simone Giovanna, Ciancimino Chiara, Caggiano Claudio, Pocobelli Giulio, Di Masi Alessandra
Ophthalmology, San Giovanni-Addolorata Hospital, Via Santo Stefano Rotondo, 6, 00184 Rome, Italy.
Department of Sciences, Section of Biomedical Sciences and Technologies, Roma Tre University, Viale Marconi 446, 00146 Rome, Italy.
J Clin Med. 2025 Jan 3;14(1):245. doi: 10.3390/jcm14010245.
: Diabetes is a well-recognised factor inducing a plethora of corneal alterations ranging from dry eye to reduced corneal sensibility, epithelial defects, and reduced cicatrisation. This cohort study aimed to assess the efficacy of a novel ophthalmic solution combining cross-linked hyaluronic acid (CHA), chondroitin sulfate (CS), and inositol (INS) in managing diabetes-induced corneal alterations. Specifically, it evaluated the solution's impact on the tear breakup time (TBUT), the ocular surface disease index (OSDI), and corneal sensitivity after three months of treatment. Additionally, the solution's potential to promote wound healing was examined. : Two different populations were retrieved from the database; the first one was composed of 20 diabetic subjects treated for three months with the ophthalmic CAH-CS (OPHTAGON srl, Rome, Italy), while the second group was composed of 20 diabetic subjects who did not want to use any eye lubricant or other treatment. The outcome measures were the TBUT, the OSDI score, and the corneal sensitivity measured using a Cochet-Bonnet aesthesiometer. To investigate the wound-healing properties, in vitro tests were conducted using two cell lines, comparing the results of scratch tests with and without the solution. : The results indicate that CHA-CS significantly improved the tear film stability, as evidenced by an increased TBUT and a reduction in dry eye symptoms reflected by lower OSDI scores. Moreover, the solution was associated with an enhanced corneal sensitivity in treated patients. In wound-healing assays, CHA-CS promoted cell motility, suggesting a supportive role in tissue repair compared to untreated cells. : Collectively, the results suggest that CHA-CS could serve as an innovative tool for the treatment of diabetic patients with corneal alterations and delayed corneal sensitivity. Clinical trial registration number: Clinical Trial.gov NCT06573606.
糖尿病是一个公认的诱发多种角膜改变的因素，这些改变包括从干眼症到角膜敏感性降低、上皮缺损以及瘢痕形成减少。这项队列研究旨在评估一种新型眼科溶液（结合了交联透明质酸（CHA）、硫酸软骨素（CS）和肌醇（INS））在管理糖尿病诱发的角膜改变方面的疗效。具体而言，它评估了该溶液在治疗三个月后对泪膜破裂时间（TBUT）、眼表疾病指数（OSDI）和角膜敏感性的影响。此外，还研究了该溶液促进伤口愈合的潜力。
从数据库中检索出两个不同的人群；第一组由20名糖尿病患者组成，他们用眼科CAH-CS（OPHTAGON srl，罗马，意大利）治疗了三个月，而第二组由20名不想使用任何眼部润滑剂或其他治疗的糖尿病患者组成。结果测量指标为TBUT、OSDI评分以及使用Cochet-Bonnet麻醉计测量的角膜敏感性。为了研究伤口愈合特性，使用两种细胞系进行了体外试验，比较了有和没有该溶液时划痕试验的结果。
结果表明，CHA-CS显著改善了泪膜稳定性，这表现为TBUT增加以及OSDI评分降低所反映的干眼症状减轻。此外，该溶液与治疗患者角膜敏感性增强有关。在伤口愈合试验中，CHA-CS促进了细胞运动，表明与未处理的细胞相比，其在组织修复中具有支持作用。
总体而言，结果表明CHA-CS可作为治疗有角膜改变和角膜敏感性延迟的糖尿病患者的一种创新工具。临床试验注册号：ClinicalTrial.gov NCT06573606。
