Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC)
Introduction Acute primary angle closure (APAC) is a common ophthalmic emergency for Chinese patients causing potential visual disabilities. According to current guidelines published by developed countries, a stepwise protocol (medication laser or paracentesis surgery) is recommended for emergency m...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open Ophthalmology |
| Online Access: | https://bmjophth.bmj.com/content/10/1/e001934.full |
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| author | Jing Jiang Qing Zhang Bo Qu Chao Dai Mingguang He Ye Zhang Ning-Li Wang Shuning Li Guangxian Tang Su Jie Fan Zhi Li Chi Liu Xinqi Chang Yanyan Cheng |
| author_facet | Jing Jiang Qing Zhang Bo Qu Chao Dai Mingguang He Ye Zhang Ning-Li Wang Shuning Li Guangxian Tang Su Jie Fan Zhi Li Chi Liu Xinqi Chang Yanyan Cheng |
| author_sort | Jing Jiang |
| collection | DOAJ |
| description | Introduction Acute primary angle closure (APAC) is a common ophthalmic emergency for Chinese patients causing potential visual disabilities. According to current guidelines published by developed countries, a stepwise protocol (medication laser or paracentesis surgery) is recommended for emergency management of APAC. However, patients with APAC in China and developed countries differ in disease characteristics as the Chinese have longer attack duration and lower success rate in breaking the attack with solely medication or laser therapy. It has been proved that long attack duration is a risk factor for failed medical or laser therapies in subsiding APAC. Since prompt and effective treatment is pivotal in preserving visual function as well as avoiding APAC-induced blindness, direct trabeculectomy may largely benefit long-attacking patients with APAC in China.Purpose The Long-Attacking Acute Angle Closure study aims to compare long-term visual function and safety after different initial treatment strategies: direct surgery (trabeculectomy) or stepwise protocol for patients with APAC with attack duration longer than 72 hours.Methods and analysis This is a pragmatic, multicentre, randomised controlled trial targeting Chinese patients with APAC duration longer than 72 hours. Eligible participants will be identified at either emergency department or glaucoma clinics, then randomised into stepped treatment group or trabeculectomy group using a computer central randomisation service. The patients will be followed up for 1 year after initial treatment.Main outcomes and measures The primary outcome is logMAR BCVA 1 year post initial treatment. Secondary outcomes consist of complete success rate in breaking the attack, intraocular pressure value, mean deviation on Humphrey visual field testing and vision-related quality of life collected using the National Eye Institute Visual Function Questionnaire (25 items) 1 year post initial treatment.Trial registration number ChiCTR2200057289. |
| format | Article |
| id | doaj-art-84bb764a43a74e5bb01c8e551e58f119 |
| institution | Kabale University |
| issn | 2397-3269 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Ophthalmology |
| spelling | doaj-art-84bb764a43a74e5bb01c8e551e58f1192025-02-07T05:30:09ZengBMJ Publishing GroupBMJ Open Ophthalmology2397-32692025-02-0110110.1136/bmjophth-2024-001934Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC)Jing Jiang0Qing Zhang1Bo Qu2Chao Dai3Mingguang He4Ye Zhang5Ning-Li Wang6Shuning Li7Guangxian Tang8Su Jie Fan9Zhi Li10Chi Liu11Xinqi Chang12Yanyan Cheng132 State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, ChinaHealth Management Center, Tianjin Medical University General Hospital, Tianjin, ChinaInstitute for International Health Professions Education and Research, China Medical University, Shenyang, Liaoning, China1 Division of Rheumatology, Department of Medicine, University of Virginia, Charlottesville, Virginia, USAThe Hong Kong Polytechnic University, Hong Kong, ChinaBeijing Tongren Hospital CMU, Beijing, China1 Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University; Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing, China1 Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology & Visual Science Key Lab, Capital Medical University, Beijing, ChinaDepartment of Ophthalmology, 1st Hospital of Shijiazhuang, Shijiazhuang, Hebei, ChinaDepartment of Ophthalmology, Handan City Eye Hospital, Handan, Hebei, China2 Department of Infectious Diseases, Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, ChinaFaculty of Data Science, City University of Macau, Macao SAR, ChinaAnyang Eye Hospital, Anyang, ChinaHebei Eye Hospital, Xingtai, Hebei, ChinaIntroduction Acute primary angle closure (APAC) is a common ophthalmic emergency for Chinese patients causing potential visual disabilities. According to current guidelines published by developed countries, a stepwise protocol (medication laser or paracentesis surgery) is recommended for emergency management of APAC. However, patients with APAC in China and developed countries differ in disease characteristics as the Chinese have longer attack duration and lower success rate in breaking the attack with solely medication or laser therapy. It has been proved that long attack duration is a risk factor for failed medical or laser therapies in subsiding APAC. Since prompt and effective treatment is pivotal in preserving visual function as well as avoiding APAC-induced blindness, direct trabeculectomy may largely benefit long-attacking patients with APAC in China.Purpose The Long-Attacking Acute Angle Closure study aims to compare long-term visual function and safety after different initial treatment strategies: direct surgery (trabeculectomy) or stepwise protocol for patients with APAC with attack duration longer than 72 hours.Methods and analysis This is a pragmatic, multicentre, randomised controlled trial targeting Chinese patients with APAC duration longer than 72 hours. Eligible participants will be identified at either emergency department or glaucoma clinics, then randomised into stepped treatment group or trabeculectomy group using a computer central randomisation service. The patients will be followed up for 1 year after initial treatment.Main outcomes and measures The primary outcome is logMAR BCVA 1 year post initial treatment. Secondary outcomes consist of complete success rate in breaking the attack, intraocular pressure value, mean deviation on Humphrey visual field testing and vision-related quality of life collected using the National Eye Institute Visual Function Questionnaire (25 items) 1 year post initial treatment.Trial registration number ChiCTR2200057289.https://bmjophth.bmj.com/content/10/1/e001934.full |
| spellingShingle | Jing Jiang Qing Zhang Bo Qu Chao Dai Mingguang He Ye Zhang Ning-Li Wang Shuning Li Guangxian Tang Su Jie Fan Zhi Li Chi Liu Xinqi Chang Yanyan Cheng Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC) BMJ Open Ophthalmology |
| title | Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC) |
| title_full | Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC) |
| title_fullStr | Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC) |
| title_full_unstemmed | Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC) |
| title_short | Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC) |
| title_sort | trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration study design and protocol for a multicentre randomised controlled trial laaac |
| url | https://bmjophth.bmj.com/content/10/1/e001934.full |
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