"Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study)"

作者全名："Gao, Xinbo; Lv, Aiguo; Lin, Fengbin; Lu, Ping; Zhang, Yi; Song, Wulian; Zhu, Xiaomin; Zhang, Hengli; Liao, Mengfei; Song, Yunhe; Hu, Kun; Zhang, Yingzhe; Peng, Yuying; Tang, Li; Yuan, Huiping; Xie, Lin; Tang, Guangxian; Nie, Xin; Jin, Ling; Fan, Sujie; Zhang, Xiulan"

作者地址："[Gao, Xinbo; Lin, Fengbin; Song, Yunhe; Hu, Kun; Zhang, Yingzhe; Peng, Yuying; Jin, Ling; Zhang, Xiulan] Sun Yat Sen Univ, Guangdong Prov Clin Res Ctr Ocular Dis, Guangdong Prov Key Lab Ophthalmol & Visual Sci, Zhongshan Ophthalm Ctr,State Key Lab Ophthalmol, Guangzhou, Guangdong, Peoples R China; [Lv, Aiguo; Lu, Ping; Fan, Sujie] Handan City Eye Hosp, Hosp Handan 3, Dept Ophthalmol, Harbin, Peoples R China; [Zhang, Yi; Tang, Li] Sichuan Univ, West China Hosp, Dept Ophthalmol, Chengdu, Sichuan, Peoples R China; [Song, Wulian; Yuan, Huiping] Harbin Med Univ, Affiliated Hosp 2, Dept Ophthalmol, Harbin, Heilongjiang, Peoples R China; [Zhu, Xiaomin; Xie, Lin] Chongqing Med Univ, Affiliated Hosp 3, Dept Ophthalmol, Chongqing, Peoples R China; [Zhang, Hengli; Tang, Guangxian] Shijiazhuang Peoples Hosp, Dept Ophthalmol, Shijiazhuang, Hebei, Peoples R China; [Liao, Mengfei; Nie, Xin] Peoples Hosp Chongqing, Dept Ophthalmol, Chongqing, Peoples R China"

通信作者："Zhang, XL (通讯作者)，Sun Yat Sen Univ, Guangdong Prov Clin Res Ctr Ocular Dis, Guangdong Prov Key Lab Ophthalmol & Visual Sci, Zhongshan Ophthalm Ctr,State Key Lab Ophthalmol, Guangzhou, Guangdong, Peoples R China.; Fan, SJ (通讯作者)，Handan City Eye Hosp, Hosp Handan 3, Dept Ophthalmol, Harbin, Peoples R China."

来源：BMJ OPEN

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000821065900008

JCR分区：Q1

影响因子：2.9

年份：2022

卷号：12

期号：7

开始页：　

结束页：　

文献类型：Article

关键词：　

摘要："Introduction Primary angle-closure glaucoma (PACG) is a major subtype of glaucoma that accounts for most bilateral glaucoma-related blindness globally. Filtering surgery is a conventional strategy for PACG, yet it has a long learning curve and undesirable disastrous complications. Minimally invasive glaucoma surgery (MIGS) plays an increasing role in the management of glaucoma due to its safer and faster recovery profile; cataract surgery-based MIGS is the most commonly performed such procedure in PACG. However, for patients with a transparent lens or no indications for cataract extraction, incorporation of MIGS into PACG treatment has not yet been reported. Therefore, this multicentre, non-inferiority, randomised controlled clinical trial aims to compare the efficacy and safety of trabeculectomy versus peripheral iridectomy plus an ab interne goniotomy in advanced PACG with no or mild cataracts. Methods and analysis This non-inferiority, multicentre, randomised controlled trial will be conducted at seven ophthalmic departments and institutes across China. Eighty-eight patients with no or mild cataracts and advanced PACG will be enrolled and randomised to undergo trabeculectomy or peripheral iridectomy plus ab intern goniotomy. Enrolled patients will undergo comprehensive ophthalmic examinations before and after surgery. The primary outcome is intraocular pressure (IOP) at 12 months postoperatively. The secondary outcomes are cumulative success rate of surgery, surgery-related complications and number of 10P-lowering medications. Participants will be followed up for 36 months postoperatively. Ethics and dissemination The study protocol was approved by the ethical committees of the Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ191) and of all subcentres. All participants will be required to provide written informed consent. The results will be published in peer-reviewed journals and disseminated in international academic meetings."

基金机构："Science and Technology Program of Guangzhou, China (2021); Science and Technology Program of Sichuan Province [2020YJ0289]; National Science Foundation of China [81670860]"

基金资助正文："This research is supported by the Science and Technology Program of Guangzhou, China (2021), the Science and Technology Program of Sichuan Province (2020YJ0289), and the National Science Foundation of China (81670860)."