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A 50% vs 30% Dose of Verteporfin (Photodynamic Therapy) for Acute Central Serous Chorioretinopathy One-Year Results of a Randomized Clinical Trial
Zhao, Mingwei1,2,3; Zhang, Feng4; Chen, Youxin5; Dai, Hong6; Qu, Jinfeng1,2,3; Dong, Chongya7; Kang, Xiaoping7; Liu, Yuling8; Yang, Liu9; Li, Yibin10; Zhou, Peng1,2,3; Pan, Chung-ting1,2,3; Zhang, Lijuan1,2,3; Liu, Peipei1,2,3; Zhou, Haiying4; Jiao, Xuan4; Xiong, Ying4; Tian, Rong5; Lu, Yingyi6; Yu, Xiaobing6; Li, Xiaoxin1,2,3
刊名JAMA OPHTHALMOLOGY
2015-03-01
DOI10.1001/jamaophthalmol.2014.5312
133期:3页:333-340
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Ophthalmology
资助者Capital Health Research and Development of Special Funding grant ; National Science and Technology Major Project grant ; Capital Health Research and Development of Special Funding grant ; National Science and Technology Major Project grant
研究领域[WOS]Ophthalmology
关键词[WOS]INDOCYANINE GREEN ANGIOGRAPHY ; TERM-FOLLOW-UP ; CYSTOID RETINAL DEGENERATION ; OPTICAL COHERENCE TOMOGRAPHY ; CHOROIDAL NEOVASCULARIZATION ; LASER PHOTOCOAGULATION ; VISUAL-ACUITY ; RETINOPATHY ; THICKNESS ; FLUENCE
英文摘要

IMPORTANCE A randomized clinical trial is needed to evaluate what is the best photodynamic therapy (PDT) protocol to use for acute central serous chorioretinopathy.

OBJECTIVE To compare the efficacy and safety of a 50% dose of verteporfin (a method of PDT) with the efficacy and safety of a 30% dose for acute central serous chorioretinopathy.

DESIGN, SETTING, AND PARTICIPANTS A multicenter, noninferiority, double-masked, randomized, controlled, clinical trial in which 131 patients (131 eyes) with acute central serous chorioretinopathy for less than 6 months were recruited with a follow-up of 12 months from university-based ophthalmology practices.

INTERVENTIONS Patients were randomly assigned to either a 50% dose of verteporfin (the 50%-dose PDT group) or a 30% dose (the 30%-dose PDT group).

MAIN OUTCOMES AND MEASURES The 2 primary outcome measures were the proportion of eyes with complete absorption of subretinal fluid and the proportion of eyes with complete disappearance of fluorescein leakage at 6 and 12 months. The secondary outcome measures included the subretinal fluid recurrent rate, the fluorescein leakage recurrent rate at 12 months, the mean best-corrected visual acuity, the retinal thickness of the foveal center, and the maximum retinal thickness at each scheduled visit.

RESULTS The noninferiority of the 30%-dose PDT compared with the 50%-dose PDT for the primary outcomes was not demonstrated. The optical coherence tomography-based improvement rate in the 30%-dose PDT group was less than that in the 50%-dose PDT group both at 6 months (73.8% vs 92.9%; alpha = 0.0125, P = .006) and at 12 months (75.4% vs 94.6%; alpha = 0.0125, P = .004). The fluorescein angiography-based improvement rate in the 30%-dose PDT group was less than that in the 50%-dose PDT group both at 6 months (68.9% vs 91.1%; alpha = 0.0125, P = .003) and at 12 months (68.9% vs 92.9%; alpha = 0.0125, P = .001). The subretinal fluid recurrence rate in the 30%-dose PDT group was greater than that in the 50%-dose PDT group (24.0% vs 5.7% at 12 months; P = .010, determined by use of the log-rank test). The fluorescein leakage recurrent rate in the 30%-dose PDT group was significantly higher than that in the 50%-dose PDT group (16.7% vs 3.8% at 12 months; P = .03, determined by use of the log-rank test). No ocular adverse event was encountered in the study.

CONCLUSIONS AND RELEVANCE A 50% dose of verteporfinmay be more effective at resolving subretinal fluid and fluorescein leakage, and with better visual outcomes, than a 30% dose for acute central serous chorioretinopathy.

语种英语
所属项目编号D101100050010026 ; 2011ZX09302-007-02
资助者Capital Health Research and Development of Special Funding grant ; National Science and Technology Major Project grant ; Capital Health Research and Development of Special Funding grant ; National Science and Technology Major Project grant
WOS记录号WOS:000351224200016
引用统计
被引频次:8[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/59360
专题北京大学第二临床医学院_眼科
作者单位1.Minist Educ, Key Lab Vis Loss & Restorat, Beijing, Peoples R China
2.Minist Hlth, Beijing Hosp, Dept Ophthalmol, Beijing, Peoples R China
3.Peking Univ Peoples Hosp, Dept Ophthalmol, Beijing 100044, Peoples R China
4.Beijing Key Lab Diag & Therapy Retinal Choroidal, Beijing, Peoples R China
5.Capital Med Univ, Beijing Tong Ren Hosp, Dept Ophthalmol, Beijing, Peoples R China
6.Beijing Union Med Coll Hosp, Dept Ophthalmol, Beijing 100730, Peoples R China
7.Peking Univ, Sch Publ Hlth, Dept Epidemiol & Biostat, Beijing 100871, Peoples R China
8.Peking Univ, Hosp 3, Dept Ophthalmol, Beijing 100871, Peoples R China
9.Peking Univ, Hosp 1, Dept Ophthalmol, Beijing 100871, Peoples R China
10.Capital Med Univ, Beijing Tong Ren Hosp, Beijing Inst Ophthalmol, Beijing, Peoples R China
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Zhao, Mingwei,Zhang, Feng,Chen, Youxin,et al. A 50% vs 30% Dose of Verteporfin (Photodynamic Therapy) for Acute Central Serous Chorioretinopathy One-Year Results of a Randomized Clinical Trial[J]. JAMA OPHTHALMOLOGY,2015,133(3):333-340.
APA Zhao, Mingwei.,Zhang, Feng.,Chen, Youxin.,Dai, Hong.,Qu, Jinfeng.,...&Li, Xiaoxin.(2015).A 50% vs 30% Dose of Verteporfin (Photodynamic Therapy) for Acute Central Serous Chorioretinopathy One-Year Results of a Randomized Clinical Trial.JAMA OPHTHALMOLOGY,133(3),333-340.
MLA Zhao, Mingwei,et al."A 50% vs 30% Dose of Verteporfin (Photodynamic Therapy) for Acute Central Serous Chorioretinopathy One-Year Results of a Randomized Clinical Trial".JAMA OPHTHALMOLOGY 133.3(2015):333-340.
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