Minimally invasive glaucoma surgery (MIGS) refers to a group of procedures generally characterized by an ab interno approach, minimal trauma to ocular tissue, moderate efficacy, an excellent safety profile, and rapid recovery. The number of MIGS procedures continues to increase, and their use has become widespread among glaucoma and cataract specialists. Standardization of the methodology and reporting of clinical endpoints in MIGS investigations enhances interpretation and comparison across different studies. The assessment of surgical interventions not only should consider statistical significance, but also whether the outcome is meaningful to patients. Minimal clinically important difference (MCID) is defined as the smallest change in a treatment outcome that is considered beneficial for an individual patient and prompts a change in their clinical management. Expert consensus is an accepted approach to determine the MCID. The American Academy of Ophthalmology’s Glaucoma Preferred Practice Pattern® Committee is an expert panel that develops guidelines identifying characteristics and components of quality eye care. The Committee recommends that the cumulative probability of surgical success at 2 years with Kaplan–Meier survival analysis be used as the primary efficacy endpoint in MIGS studies. The Committee suggests that surgical success for standalone MIGS be defined as intraocular pressure (IOP) of 21 mmHg or less and reduced by 20% or more from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The proposed MCID for the cumulative probability of success of standalone MIGS at 2 years is 50%. The panel recommends that surgical success for MIGS combined with cataract extraction with intraocular lens implantation (CE-IOL) be defined as a decrease in glaucoma medical therapy of 1 medication or more from baseline without an increase in IOP or IOP of 21 mmHg or less and reduced by 20% or more from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The suggested MCID for the cumulative probability of success for MIGS combined with CE-IOL at 2 years is 65%.

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特别评论：报告微创青光眼手术研究的临床终点


微创青光眼手术 （MIGS） 是指一组手术，通常具有 ab interno 入路、对眼组织创伤最小、疗效适中、安全性好和恢复快等特点。MIGS 手术的数量不断增加，它们的使用在青光眼和白内障专家中已得到广泛应用。MIGS 调查中临床终点的方法学和报告的标准化增强了不同研究之间的解释和比较。手术干预的评估不仅应考虑统计学意义，还应考虑结果是否对患者有意义。最小临床重要差异 （MCID） 定义为治疗结果中被认为对个体患者有益并促使其临床管理发生变化的最小变化。专家共识是确定 MCID 的公认方法。美国眼科学会的青光眼首选实践模式委员会是一个专家小组，负责制定指南，®确定优质眼科护理的特征和组成部分。委员会建议将 Kaplan-Meier 生存分析在 2 年时手术成功的累积概率用作 MIGS 研究的主要疗效终点。委员会建议将独立 MIGS 的手术成功定义为眼压 （IOP） 为 21 mmHg 或更低，并且较基线降低 20% 或更多，而没有增加青光眼药物、额外的激光或切口青光眼手术、光知觉丧失或低眼压。独立 MIGS 在 2 年时累积成功概率的拟议 MCID 为 50%。 专家组建议将 MIGS 联合白内障摘除术联合人工晶状体植入术 （CE-IOL） 的手术成功定义为青光眼药物治疗从基线减少 1 种或更多药物，而眼压增加或 IOP 不超过 21 mmHg，并且比基线减少 20% 或更多，而青光眼药物没有增加， 额外的激光或切口青光眼手术、光知觉视力丧失或低眼压。MIGS 联合 CE-IOL 在 2 年时的累积成功概率的建议 MCID 为 65%。