Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial
机构：[1]Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-sen University, 54 South Xianlie Road, Guangzhou, People’s Republic of China.[2]Hebei Provincial Eye Hospital, Xingtai City, Hebei, People’s Republic of China.[3]Handan Eye Hospital, Handan City, Hebei, People’s Republic of China.[4]Department of Ophthalmology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, People’s Republic of China.华中科技大学同济医学院附属同济医院[5]Department of Ophthalmology, Daping Hospital, The Third Military Medical University, Chongqing, Hubei, People’s Republic of China.[6]Liaoning He University, He Eye Hospital, Shenyang, Liaoning, People’s Republic of China.[7]Department of Ophthalmology, the Second Xiangya Hospital, Central South University, Changsha, Hunan, People’s Republic of China.[8]Department of Ophthalmology, the Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People’s Republic of China.[9]Clinical and Epidemiological Research Center, the Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China.[10]Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology and Visual Science Key Laboratory, No. 1 Dong Jiao Min Xiang Street, Dongcheng District, Beijing, People’s Republic of China.首都医科大学附属北京同仁医院临床科室眼科亦庄院区眼科[11]Department of Biostatistics, School of Public Health and Tropical Medicine, Southern Medical University, Guangzhou, Guangdong, People’s Republic of China.
Background: China has the largest burden of primary angle-closure glaucoma (PACG) worldwide. The mechanism of the angle closure is complex and includes pupillary block and non-pupillary block. Currently, opinion is that laser peripheral iridotomy (LPI) alone is not sufficient to prevent disease progression. Laser peripheral iridoplasty (LPIP) is an alternative and effective way of widening the angle recess in eyes that are affected by primary angle closure (PAC). However, it is not known if greater benefit would be achieved using LPI plus LPIP for PAC with multiple mechanisms (MAC). Thus, the aim of this study is to demonstrate if LPI plus LPIP would be more effective than single LPI in controlling the progression of PAC with multiple mechanisms, based on ultrasound biomicroscopy (UBM) classification. A secondary aim is to determine whether or not this would result in the use of less medication and/or prolong the time to antiglaucoma surgery. Methods: This multiple-mechanism angle-closure study will comprise a 3-year, multicenter, randomized, parallel-group, open-label, superiority trial, the aim of which will be to evaluate the safety and efficacy of LPI plus LPIP versus LPI for PAC. It is anticipated that 240 adults, diagnosed with PAC (the mechanism of angle closure will be assessed by UBM and it will be determined whether or not it involves multiple mechanisms) will be recruited from ten ophthalmic centers in China. Participants will be randomly allocated to receive either single LPI or LPI plus LPIP. Participant assessment will be designed to test the rate of disease progression and who will be followed up for 3 years. The primary outcome will be the disease progression rate and a comparison will be made between the LPI and LPI plus LPIP groups using Pearson's.2 test. Logistic regression analysis will be performed to account for the central effect. Discussion: If the LPI plus LPIP is found to significantly decrease the rate of PAC progression, this intervention could potentially be a standard therapy to be used to treat PAC when multiple mechanisms are involved in angle closure. Subsequently, this would have the potential to delay the rate of PAC progression to PACG and delay the time to the administration of antiglaucoma medication or trabeculectomy surgery.
基金：
This study is supported by Sun Yat-sen University Clinical Research 5010 Program
(2015019), based on the ethically approved study protocol (version 2, 24 November
2015) and the supporting study documents (i.e., the patient information sheet,
consent form, and standard operation procedure sheet). The study protocol was
also reviewed by the “5010 Plan” evaluation committee at Sun Yat-sen University,
Guangzhou, China. Every year the evaluation committee will examine the study
progress and adherence to the study protocol.
第一作者机构：[1]Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-sen University, 54 South Xianlie Road, Guangzhou, People’s Republic of China.
通讯作者：
推荐引用方式(GB/T 7714)：
Chen Shida,Lv Jianhua,Fan Sujie,et al.Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial[J].TRIALS.2017,18:doi:10.1186/s13063-017-1860-4.
APA：
Chen, Shida,Lv, Jianhua,Fan, Sujie,Zhang, Hong,Xie, Lin...&Wang, Ningli.(2017).Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial.TRIALS,18,
MLA：
Chen, Shida,et al."Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial".TRIALS 18.(2017)
