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, Li Chen, Peiquan Zhao, Jiao Lyn, Qiang Lu, Yan Shao, Xinjun Ren, Xiaorong Li
{"title":"透明质酸水凝胶作为视网膜贴片治疗孔源性视网膜脱离：一项多中心随机平行对照试验。","authors":"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, Li Chen, Peiquan Zhao, Jiao Lyn, Qiang Lu, Yan Shao, Xinjun Ren, Xiaorong Li","doi":"10.1111/ceo.14570","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2000037030.</p>","PeriodicalId":55253,"journal":{"name":"Clinical and Experimental Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.9000,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Hyaluronic Acid Hydrogel as a Retinal Patch in the Treatment of Rhegmatogenous Retinal Detachment: A Multicenter Randomised Parallel-Controlled Trial.\",\"authors\":\"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, Li Chen, Peiquan Zhao, Jiao Lyn, Qiang Lu, Yan Shao, Xinjun Ren, Xiaorong Li\",\"doi\":\"10.1111/ceo.14570\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2000037030.</p>\",\"PeriodicalId\":55253,\"journal\":{\"name\":\"Clinical and Experimental Ophthalmology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2025-07-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Experimental Ophthalmology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/ceo.14570\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Experimental Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/ceo.14570","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Hyaluronic Acid Hydrogel as a Retinal Patch in the Treatment of Rhegmatogenous Retinal Detachment: A Multicenter Randomised Parallel-Controlled Trial.
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.
期刊介绍：
Clinical & Experimental Ophthalmology is the official journal of The Royal Australian and New Zealand College of Ophthalmologists. The journal publishes peer-reviewed original research and reviews dealing with all aspects of clinical practice and research which are international in scope and application. CEO recognises the importance of collaborative research and welcomes papers that have a direct influence on ophthalmic practice but are not unique to ophthalmology.
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