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)
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...
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BMJ Publishing Group
2022-07-01
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| author | Keith Barton Tin Aung Ling Jin Ping Lu Xiulan Zhang Robert N Weinreb Yi Zhang Li Tang Guangxian Tang Hengli Zhang Aiguo Lv Huiping Yuan Yunhe Song Fengbin Lin DENNIS S C LAM Lin Xie Kun Hu Xiaohong Liang Yingzhe Zhang Wulian Song Xiaomin Zhu Xinbo Gao Sujie Fan Yuying Peng Mengfei Liao Xin Nie Ki-Ho Park |
| author_facet | Keith Barton Tin Aung Ling Jin Ping Lu Xiulan Zhang Robert N Weinreb Yi Zhang Li Tang Guangxian Tang Hengli Zhang Aiguo Lv Huiping Yuan Yunhe Song Fengbin Lin DENNIS S C LAM Lin Xie Kun Hu Xiaohong Liang Yingzhe Zhang Wulian Song Xiaomin Zhu Xinbo Gao Sujie Fan Yuying Peng Mengfei Liao Xin Nie Ki-Ho Park |
| author_sort | Keith Barton |
| collection | DOAJ |
| description | 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 interno 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 interno 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 IOP-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.Trial registration number NCT05163951. |
| format | Article |
| id | doaj-art-d9051fb3bdfa406786ecdd6660ccd0eb |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
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| spelling | doaj-art-d9051fb3bdfa406786ecdd6660ccd0eb2025-01-31T14:25:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-062441Efficacy 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)Keith BartonTin Aung0Ling Jin1Ping Lu2Xiulan Zhang3Robert N Weinreb4Yi Zhang5Li Tang6Guangxian Tang7Hengli Zhang8Aiguo Lv9Huiping Yuan10Yunhe Song11Fengbin Lin12DENNIS S C LAM13Lin Xie14Kun Hu15Xiaohong LiangYingzhe Zhang16Wulian Song17Xiaomin Zhu18Xinbo Gao19Sujie Fan20Yuying Peng21Mengfei Liao22Xin Nie23Ki-Ho ParkOphthalmology & Visual Sciences Academic Clinical Program (EYE-ACP), Duke-NUS Medical School, Singapore1 Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, Guangzhou, Guangdong, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, 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, ChinaViterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA2Gilead Sciences Inc, 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, China2 Department of Ophthalmology, 1st Hospital of Shijiazhuang, Shijiazhuang, 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, 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, China4 The International Eye Research Institute, the Chinese University of Hong Kong (Shenzhen), Shenzhen, ChinaDepartment of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, 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, 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, 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, Handan City Eye Hospital (The Third Hospital of Handan), Handan, Hebei, 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, People`s Hospital of Chongqing, Chongqing, ChinaDepartment of Ophthalmology, People`s Hospital of Chongqing, Chongqing, ChinaIntroduction 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 interno 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 interno 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 IOP-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.Trial registration number NCT05163951.https://bmjopen.bmj.com/content/12/7/e062441.full |
| spellingShingle | Keith Barton Tin Aung Ling Jin Ping Lu Xiulan Zhang Robert N Weinreb Yi Zhang Li Tang Guangxian Tang Hengli Zhang Aiguo Lv Huiping Yuan Yunhe Song Fengbin Lin DENNIS S C LAM Lin Xie Kun Hu Xiaohong Liang Yingzhe Zhang Wulian Song Xiaomin Zhu Xinbo Gao Sujie Fan Yuying Peng Mengfei Liao Xin Nie Ki-Ho Park 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/7/e062441.full |
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