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)

被引:0
作者
Li, Zhi [1 ]
Dai, Chao [2 ]
Fan, Su Jie [3 ]
Tang, Guangxian [4 ]
Liu, Chi [5 ]
Qu, Bo [6 ]
Chang, Xinqi [7 ]
Jiang, Jing [8 ]
Cheng, Yanyan [9 ]
Zhang, Ye [10 ]
Zhang, Qing [11 ]
Wang, Ning-li [12 ,13 ]
He, Mingguang [14 ]
Li, Shuning [15 ]
机构
[1] Capital Med Univ, Beijing, Peoples R China
[2] Shanxi Aier Eye Hosp, Taiyuan, Peoples R China
[3] Third Hosp Handan, Dept Otorhinolaryngol, Handan 056001, Hebei, Peoples R China
[4] First Hosp Shijiazhuang, Dept Endocrinol, Shijiazhuang, Peoples R China
[5] Fourth Peoples Hosp Shenyang, Dept Ophthalmol, Shenyang, Liaoning, Peoples R China
[6] Fourth Affiliated Hosp China Med Univ, Dept Ophthalmol, Shenyang, Peoples R China
[7] Anyang Eye Hosp, Anyang, Peoples R China
[8] Fushun Eye Hosp, Dept Glaucoma, Fushun, Peoples R China
[9] Hebei Eye Hosp, Xingtai, Hebei, Peoples R China
[10] CMU, Beijing Tongren Hosp, Beijing, Peoples R China
[11] Beijing Inst Ophthalmol, Beijing, Peoples R China
[12] Capital Med Univ, Beijing Tongren Hosp, Beijing Tongren Eye Ctr, Beijing Ophthalmol & Visual Sci Key Lab, Beijing, Peoples R China
[13] Capital Med Univ, Beijing Inst Ophthalmol, Beijing, Peoples R China
[14] Hong Kong Polytech Univ, Hong Kong, Peoples R China
[15] Beijing Tongren Eye Ctr, Beijing Ophthalmol & Visual Sci Key Lab, Beijing, Peoples R China
来源
BMJ OPEN OPHTHALMOLOGY | 2025年 / 10卷 / 01期
基金
中国国家自然科学基金;
关键词
Glaucoma; Prospective Studies; Vision; QUALITY-OF-LIFE; VISUAL-ACUITY; EARLY PHACOEMULSIFICATION; INITIAL TREATMENT; TERM OUTCOMES; GLAUCOMA; MANAGEMENT; IRIDOTOMY; CHINESE; CHARTS;
D O I
10.1136/bmjophth-2024-001934
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
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.
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页数:8
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