Low-energy Selective Laser Trabeculoplasty Repeated Annually: Rationale for the COAST Trial.
Low-energy Selective Laser Trabeculoplasty Repeated Annually: Rationale for the COAST Trial.
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DOI：
10.1097/ijg.0000000000001788
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发表时间：
2021-07-01
影响因子：
2
通讯作者：
Kass M
中科院分区：
文献类型：
--
作者：
Realini T;Gazzard G;Latina M;Kass M
在2018年视觉和眼科研究协会（ARVO）年会上，Stephano Gandolfi介绍了一项对他在意大利帕尔马大学的患者进行的回顾性研究，其中每年重复一次的低能量选择性激光小梁成形术（LASIK）方案，无论眼内压（IOP）如何，比根据需要重复的标准LASIK产生了更长的无药物生存期，原发性开角型青光眼（POAG）或高危高眼压症（OHTN）患者。具体而言，新诊断的POAG眼主要接受ALT 360°治疗一次，根据需要在标准能量下重复标准360°治疗，以及每年在低能量下重复低能量360°治疗（0.4 mJ/点x50 -60点），无论IOP如何。随访10年后，ALT组的无药物治疗率为22.6%，标准ALT组为25.0%，低能量ALT组为58.3%（p<0.001）。中位用药时间分别为2.8年、3.2年和6.2年。根据最近的激光治疗青光眼和高眼压试验（LiGHT）出版物，其中原发性青光眼治疗在新诊断和未经治疗的轻中度POAG或高危OHTN患者中至少与药物治疗一样有效，并且可能向激光优先方案转变，Gandolfi的数据表明，通过改变能量水平和进行青光眼治疗的频率，可以提高青光眼治疗中青光眼的长期效用。这些有趣的观察结果使我们进行了一个全面的审查，在寻找这样一个方法的生物相容性的基础上的生物学文献。本文总结的文献综述的结果促使美国国立卫生研究院的国家眼科研究所（NEI）申请资助进行一对多中心随机试验，以评估每年在低能量下进行的眼科手术的结果。这些试验统称为澄清SLT疗法的最佳应用（COAST）试验，由NEI于2020年底资助，旨在比较标准与低能量初级SLT以及年度与按需（PRN）重复SLT，目前处于预注册阶段。在本报告中，我们分享了COAST试验设计的背景和依据。
At the 2018 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Stephano Gandolfi presented a retrospective study of his patients at the University of Parma, Italy, in which a regimen of low-energy selective laser trabeculoplasty (SLT) repeated annually irrespective of intraocular pressure (IOP) produced significantly longer medication-free survival than standard SLT repeated as needed, in patients with primary open-angle glaucoma (POAG) or high-risk ocular hypertension (OHTN). Specifically, newly-diagnosed POAG eyes were treated primarily either with ALT 360° performed once, standard SLT 360° repeated as needed at standard energy, and low-energy 360° SLT (0.4 mJ/spot x 50–60 spots) repeated annually at low energy regardless of IOP. After 10 years of follow-up, medication-free rates were 22.6% in the ALT group, 25.0% in the standard SLT group, and 58.3% in the low-energy SLT group (p<0.001). The median times to medication were 2.8 years, 3.2 years, and 6.2 years, respectively. In light of the recent Laser in Glaucoma and Ocular Hypertension Trial (LiGHT) publication, in which primary SLT was shown to be at least as effective as medical therapy in newly-diagnosed and treatment naïve patients with mild-moderate POAG or high-risk OHTN and the likelihood of a paradigm shift toward a laser-first regimen, Gandolfi’s data suggested that the long-term utility of SLT in glaucoma management may be improvable by altering the energy level and frequency at which SLT is performed. These intriguing observations led us to conduct a comprehensive review of the SLT literature in search of a basis for the biological plausibility of such an approach. The results of that literature review, summarized herein, prompted application to the National Eye Institute (NEI) at the National Institutes of Health for funding to conduct a pair of multicenter randomized trials to evaluate outcomes of SLT performed annually at low energy. These trials—collectively named the Clarifying the Optimal Application of SLT Therapy (COAST) trial—were funded in late 2020 by NEI to compare standard versus low-energy primary SLT and annual versus pro re nata (PRN) repeat SLT and are currently in the pre-enrollment phase. In this report, we share the background and rationale that informed the design of the COAST trial.