Pars plana vitrectomy for retinal detachment using perfluoro-n-octane as intraoperative tamponade:a multicenter,randomized,non-inferiority trial  

作　　者：Xin Shi Wei-Jun Wang Ying Fan Hai-Yun Liu Hong Wang Yu-Hui Chen Ao Rong Zhi-Feng Wu Xun Xu Kun Liu 

机构地区：[1]Department of Ophthalmology,Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine,National Clinical Research Center for Eye Diseases,Shanghai Key Laboratory of Ocular Fundus Diseases,Shanghai Engineering Center for Visual Science and Photomedicine,Shanghai Engineering Center for Precise Diagnosis and Treatment of Eye Diseases,Shanghai 200085,China [2]Shanghai Jieshi Medical Technology Co.Ltd.,Shanghai 201201,China [3]Department of Ophthalmology,Tongji Hospital,School of Medicine,Tongji University,Shanghai 200065,China [4]Department of Ophthalmology,Wuxi No.2 People’s Hospital(Jiangnan University Medical Center,JUMC),Wuxi 214002,Jiangsu Province,China

出　　处：《International Journal of Ophthalmology(English edition)》2024年第1期82-91,共10页国际眼科杂志（英文版）

基　　金：Supported by the Program of Shanghai Academic/Technology Research Leader(No.21XD1402700);the Clinical Research Plan of Shenkang Hospital Development Center of Shanghai(No.SHDC2022CRD001).

摘　　要：AIM:To evaluate the efficacy and safety of perfluoro-n-octane(PFO)for ophthalmic surgery versus F-Octane as an intraoperative tamponade in pars plana vitrectomy(PPV)in management of retinal detachment.METHODS:This multicenter,prospective,randomized,double-masked,parallel-controlled,non-inferiority trial was conducted in three ophthalmology clinical centers in China.Patients with retinal detachment,who were eligible for PPV were consecutively enrolled.Participants were assigned to PFO for ophthalmic surgery or F-Octane for intraocular tamponade in a 1:1 ratio.Best-corrected visual acuity(BCVA),intraocular pressure(IOP)measurement,and dilated fundus examination were performed preoperatively and at 1,7±1,28±3d postoperatively.The primary outcome was complete retinal reattachment rate at postoperative day one.The non-inferiority margin was set at 9.8%.The secondary outcomes included intraoperative retinal reattachment rate,and mean changes in IOP and BCVA from baseline to 1,7±1,28±3d postoperatively,respectively.Safety analyses were presented for all randomly assigned participates in this study.RESULTS:Totally 124 eligible patients completed the study between Mar.14,2016 and Jun.7,2017.Sixty of them were randomly assigned to the PFO for ophthalmic surgery group,and 64 were assigned to the F-Octane group.Baseline characteristics were comparable between the two groups.Both groups achieved 100%retinal reattachment at postoperative day one(difference 0,95%CI:-6.21%to 5.75%,P=1).The pre-defined noninferiority criterion was met.No significant difference was observed in intraoperative retinal reattachment rate(difference 1.77%,P=0.61),mean changes in IOP(difference 0.36,-0.09,2.22 mm Hg at 1,7±1,28±3d postoperatively,with all P>0.05)and BCVA(difference 0.04,-0.02,0.06 logMAR at 1,7±1,28±3d postoperatively,all P>0.05)between the two groups.No apparent adverse events related to the utilization of PFO were reported.CONCLUSION:In patients with retinal detachment undergoing PPV,PFO for ophthalmic surgery is non-inferior

关 键 词：perfluoro-n-octane vitreoretinal surgery intraocular tamponade ophthalmic surgery retinal detachment 

分 类 号：R779.6[医药卫生—眼科]