Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study)
Introduction Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate across Asia. The first-line treatment of PACG is surgery, and phacotrabeculectomy remains the mainstream surgery for advanced PACG. However, it may cause vision-threatening complications with long learning cur...
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BMJ Publishing Group
2021-12-01
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| Online Access: | https://bmjopen.bmj.com/content/11/12/e056876.full |
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| author | Xiulan Zhang Xi Zhang Yi Zhang Li Tang Guangxian Tang Hengli Zhang Aiguo Lv Huiping Yuan Yunhe Song Lin Xie Lan Lu Kun Hu Xiaohong Liang Xiaowei Yan Yingzhe Zhang Wulian Song Meichun Xiao Xiaohuan Zhao Xiaomin Zhu Xinbo Gao Minwen Zhou Sujie Fan |
| author_facet | Xiulan Zhang Xi Zhang Yi Zhang Li Tang Guangxian Tang Hengli Zhang Aiguo Lv Huiping Yuan Yunhe Song Lin Xie Lan Lu Kun Hu Xiaohong Liang Xiaowei Yan Yingzhe Zhang Wulian Song Meichun Xiao Xiaohuan Zhao Xiaomin Zhu Xinbo Gao Minwen Zhou Sujie Fan |
| author_sort | Xiulan Zhang |
| collection | DOAJ |
| description | Introduction Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate across Asia. The first-line treatment of PACG is surgery, and phacotrabeculectomy remains the mainstream surgery for advanced PACG. However, it may cause vision-threatening complications with long learning curve. Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed. Therefore, this study aimed to conduct a multicentre, non-inferiority randomised controlled clinical trial to compare the efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced PACG.Methods and analysis This is a non-inferiority multicentre randomised controlled trial and will be conducted at eight ophthalmic departments and institutes in China. 124 patients with advanced PACG will be enrolled and randomised to undergo phacotrabeculectomy or phacogoniotomy. Comprehensive ophthalmic examinations will be performed before and after the surgery. The primary outcome is the change of intraocular pressure at 12 months after surgery compared with the baseline intraocular pressure. An extended follow-up period of 36 months will be required. Cumulative success rate of surgery, intraoperative and postoperative complications, and number of anti-glaucomatous medications will also be compared between the groups as secondary outcomes.Ethics and dissemination Ethical approval has been obtained from the ethical committee of Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ090) and all subcentres. All the participants will be required to provide written informed consent. The results will be disseminated through scientific meetings and published in peer-reviewed journals.Trial registration number NCT04878458. |
| format | Article |
| id | doaj-art-633b1538439643bc91043bf0cdea0dbc |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-633b1538439643bc91043bf0cdea0dbc2024-12-08T11:05:13ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-056876Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study)Xiulan Zhang0Xi Zhang1Yi Zhang2Li Tang3Guangxian Tang4Hengli Zhang5Aiguo Lv6Huiping Yuan7Yunhe Song8Lin Xie9Lan Lu10Kun Hu11Xiaohong Liang12Xiaowei Yan13Yingzhe Zhang14Wulian Song15Meichun Xiao16Xiaohuan Zhao17Xiaomin Zhu18Xinbo Gao19Minwen Zhou20Sujie Fan21State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, ChinaState Key Laboratory of Trauma and Chemical Poisoning, Chongqing Key Clinical Specialty, Chongqing Key Laboratory of Hematology and Microenvironment, Chongqing, Chongqing, China1Gilead Sciences, Foster City, CA, USA1 Department of Nephrology, First Medical Center of Chinese PLA General Hospital, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney, Beijing, ChinaDepartment of Ophthalmology, 1st Hospital of Shijiazhuang, Shijiazhuang, Hebei, ChinaDepartment of Ophthalmology, 1st Hospital of Shijiazhuang, Shijiazhuang, Hebei, ChinaDepartment of Ophthalmology, Handan 3rd Hospital, Handan, Hebei, ChinaDepartment of Ophthalmology, The second Affiliated Hospital, Harbin Medical University, Harbin, Heilongjiang, China1 State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, ChinaSchool of Medicine, Hangzhou Normal University, Hangzhou, Zhejiang, ChinaDepartment of Ophthalmology, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China1 Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USAState Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Ophthalmology, Shijiazhuang People’s Hospital, Shijiazhuang, Hebei Province, ChinaState Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, Guangdong, ChinaDepartment of Ophthalmology, The second Affiliated Hospital, Harbin Medical University, Harbin, Heilongjiang, ChinaDepartment of Ophthalmology, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, ChinaDepartment of Ophthalmology, Shanghai General Hospital (Shanghai First People’s Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China1 State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, ChinaDepartment of Ophthalmology, Shanghai General Hospital (Shanghai First People’s Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaHandan City Eye Hospital, Handan, ChinaIntroduction Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate across Asia. The first-line treatment of PACG is surgery, and phacotrabeculectomy remains the mainstream surgery for advanced PACG. However, it may cause vision-threatening complications with long learning curve. Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed. Therefore, this study aimed to conduct a multicentre, non-inferiority randomised controlled clinical trial to compare the efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced PACG.Methods and analysis This is a non-inferiority multicentre randomised controlled trial and will be conducted at eight ophthalmic departments and institutes in China. 124 patients with advanced PACG will be enrolled and randomised to undergo phacotrabeculectomy or phacogoniotomy. Comprehensive ophthalmic examinations will be performed before and after the surgery. The primary outcome is the change of intraocular pressure at 12 months after surgery compared with the baseline intraocular pressure. An extended follow-up period of 36 months will be required. Cumulative success rate of surgery, intraoperative and postoperative complications, and number of anti-glaucomatous medications will also be compared between the groups as secondary outcomes.Ethics and dissemination Ethical approval has been obtained from the ethical committee of Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ090) and all subcentres. All the participants will be required to provide written informed consent. The results will be disseminated through scientific meetings and published in peer-reviewed journals.Trial registration number NCT04878458.https://bmjopen.bmj.com/content/11/12/e056876.full |
| spellingShingle | Xiulan Zhang Xi Zhang Yi Zhang Li Tang Guangxian Tang Hengli Zhang Aiguo Lv Huiping Yuan Yunhe Song Lin Xie Lan Lu Kun Hu Xiaohong Liang Xiaowei Yan Yingzhe Zhang Wulian Song Meichun Xiao Xiaohuan Zhao Xiaomin Zhu Xinbo Gao Minwen Zhou Sujie Fan Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study) BMJ Open |
| title | Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study) |
| title_full | Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study) |
| title_fullStr | Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study) |
| title_full_unstemmed | Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study) |
| title_short | Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study) |
| title_sort | efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle closure glaucoma study protocol for a multicentre non inferiority randomised controlled trial pvp study |
| url | https://bmjopen.bmj.com/content/11/12/e056876.full |
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