Chen Shida, Lv Jianhua, Fan Sujie, Zhang Hong, Xie Lin, Xu Ling, Jiang Bing, Yuan Huipin, Liang Yuanbo, Li Shuning, Chen Pingyan, Zhang Xiulan, Wang Ningli
Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-sen University, 54 South Xianlie Road, Guangzhou, People's Republic of China.
Hebei Provincial Eye Hospital, Xingtai City, Hebei, People's Republic of China.
Trials. 2017 Mar 17;18(1):130. doi: 10.1186/s13063-017-1860-4.
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.
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 χ test. Logistic regression analysis will be performed to account for the central effect.
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.
ClinicalTrials.gov, NCT02613013 . Registered on 24 November 2015. In fact, the study was due to start in late October 2015, however, there were no patients recruited in October, and when we registered at ClinicalTrials.gov on 5 November 2015, we received suggestions on the English translation of our protocol from the PRS Team at Clinicaltrial.gov, so the final successful registration date was on 24 November 2015.
在全球范围内，中国原发性闭角型青光眼（PACG）的负担最为沉重。房角关闭的机制复杂，包括瞳孔阻滞和非瞳孔阻滞。目前，人们认为单纯激光周边虹膜切开术（LPI）不足以预防疾病进展。激光周边虹膜成形术（LPIP）是一种扩大原发性房角关闭（PAC）患眼房角隐窝的有效替代方法。然而，对于具有多种机制的PAC（MAC），联合使用LPI和LPIP是否能带来更大益处尚不清楚。因此，本研究的目的是基于超声生物显微镜（UBM）分类，证明联合使用LPI和LPIP在控制具有多种机制的PAC进展方面是否比单纯LPI更有效。次要目的是确定这是否会减少药物使用和/或延长至抗青光眼手术的时间。
这项多机制房角关闭研究将是一项为期3年的多中心、随机、平行组、开放标签的优效性试验，旨在评估LPI联合LPIP与LPI治疗PAC的安全性和有效性。预计将从中国的10个眼科中心招募240名被诊断为PAC的成年人（房角关闭机制将通过UBM评估，并确定是否涉及多种机制）。参与者将被随机分配接受单纯LPI或LPI联合LPIP治疗。参与者评估将旨在测试疾病进展率，并对其进行3年的随访。主要结局将是疾病进展率，并使用Pearson卡方检验对LPI组和LPI联合LPIP组进行比较。将进行逻辑回归分析以考虑中心效应。
如果发现LPI联合LPIP能显著降低PAC进展率，那么这种干预措施可能会成为治疗房角关闭涉及多种机制的PAC的标准疗法。随后，这有可能延缓PAC进展为PACG的速度，并延迟抗青光眼药物给药或小梁切除术的时间。
ClinicalTrials.gov，NCT02613013。于2015年11月24日注册。实际上，该研究原定于2015年10月下旬开始，但10月没有招募到患者，当我们于2015年11月5日在ClinicalTrials.gov注册时，收到了Clinicaltrial.gov的PRS团队关于我们方案英文翻译的建议，所以最终成功注册日期为2015年11月24日。
