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

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机构: [1]Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, China [2]Shanxi Eye Hospital, Taiyuan, Shanxi Province, China [3]Department of Ophthalmology, The Second Hospital of Hebei Medical University, Shijiazhuang, China [4]Department of Ophthalmology, The First Affiliated Hospital of Dalian Medical University, Dalian, China [5]Department of Ophthalmology, Jiangsu Province Hospital, the First Affiliated Hospital With Nanjing Medical University, Jiangsu Women and Children Health Hospital, Nanjing, Jiangsu, China [6]Department of Ophthalmology, Key Laboratory of Vision Loss and Restoration, Ministry of Education, Peking University Third Hospital, Beijing, China [7]The Department of Ophthalmology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China [8]Department of Ophthalmology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [9]Shanghai Haohai Biological Technology Co. Ltd., Shanghai, China
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关键词: clinical trial linearly cross-linked sodium HA hydrogel prone positioning rhegmatogenous retinal detachment

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BackgroundTo 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).MethodsThis 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.ResultsAt 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.ConclusionsThe 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 RegistrationChinese Clinical Trial Registry: ChiCTR2000037030

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大类 | 2 区 医学
小类 | 2 区 眼科学
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大类 | 2 区 医学
小类 | 2 区 眼科学
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出版当年[2023]版:
Q1 OPHTHALMOLOGY
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Q1 OPHTHALMOLOGY

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第一作者机构: [1]Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, China
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