Hyaluronic Acid Hydrogel as a Retinal Patch in the Treatment of Rhegmatogenous Retinal Detachment: A Multicenter Randomised Parallel‐Controlled Trial

医学 视网膜脱离 视网膜 眼科 多中心研究 随机对照试验 多中心试验 透明质酸 外科 解剖
作者
Boshi Liu,Manqiao Wang,Liangzhang Tan,Emmanuel Eric Pazo,Lili Yuan,Qingli Shang,Jingxue Ma,Jianmin Wang,Xiang Ma,Cong Ma,Qinghuai Liu,Jiangdong Ji,Yao Lu,Yong Tao,L Chen,Peiquan Zhao,Jiao Lyn,Qiang Lu,Yan Shao,Xinjun Ren
出处
期刊:Clinical and Experimental Ophthalmology [Wiley]
卷期号:53 (8): 946-955 被引量:4
标识
DOI:10.1111/ceo.14570
摘要

BACKGROUND: To evaluate the efficacy and safety of a linearly cross-linked sodium hyaluronic acid (HA) hydrogel used as a retinal patch in the treatment of rhegmatogenous retinal detachment (RRD). METHODS: This multicenter, randomised, parallel-controlled trial included 313 participants diagnosed with RRD classified as PVR grade A or B, excluding those with giant retinal tears (defined as tears spanning more than one quadrant). Participants were randomly assigned to either an experimental group or a control group. Following laser photocoagulation to retinal breaks, the experimental group received intraocular tamponade with a combination of linearly cross-linked sodium HA hydrogel and sterile air, whereas the control group received intraocular tamponade with perfluoropropane gas (C3F8). According to the intention-to-treat (ITT) principle, the final analysis included 155 subjects in the experimental group and 158 in the control group. The primary outcome measure was the retinal reattachment rate within 24 weeks postoperatively. RESULTS: At 24 weeks, retinal reattachment rates were 91.8% in the experimental group and 91.4% in the control group (p = 0.903), with no statistically significant differences at any follow-up time point. Additionally, there were no significant differences between the two groups regarding best-corrected visual acuity (BCVA), intraocular pressure (IOP), or postoperative complications. CONCLUSIONS: The application of linearly cross-linked sodium HA hydrogel as a retinal patch demonstrated effectiveness comparable to traditional gas tamponade in the treatment of RRD. Furthermore, this method exhibited a favourable safety profile. The technique obviates the need for postoperative prone positioning, significantly improving the patient's postoperative comfort and quality of life. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000037030.
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