Gedde Steven J, Vinod Kateki, Bowden Eileen C, Kolomeyer Natasha N, Chopra Vikas, Challa Pratap, Budenz Donald L, Repka Michael X, Lum Flora
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Department of Ophthalmology, Icahn School of Medicine at Mount Sinai and New York Eye and Ear Infirmary of Mount Sinai, New York, New York.
Ophthalmology. 2025 Feb;132(2):141-153. doi: 10.1016/j.ophtha.2024.07.030. Epub 2024 Aug 8.
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%. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
微创青光眼手术（MIGS）是指一组通常以内路入路为特征的手术，对眼组织的创伤极小，疗效中等，安全性极佳，恢复迅速。MIGS手术的数量持续增加，并且在青光眼和白内障专科医生中已广泛应用。MIGS研究中方法学的标准化以及临床终点的报告有助于不同研究之间的解读和比较。手术干预的评估不仅应考虑统计学意义，还应考虑结果对患者是否有意义。最小临床重要差异（MCID）被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改变的最小变化。专家共识是确定MCID的一种公认方法。美国眼科学会青光眼首选实践模式®委员会是一个专家小组，负责制定确定优质眼部护理特征和组成部分的指南。该委员会建议，在MIGS研究中，使用Kaplan-Meier生存分析得出的2年手术成功率的累积概率作为主要疗效终点。该委员会建议，单独MIGS手术成功的定义为眼压（IOP）为21 mmHg或更低，且较基线降低20%或更多，同时不增加青光眼药物使用、不进行额外的激光或切开性青光眼手术、无光感视力丧失或低眼压。单独MIGS手术2年成功累积概率的提议MCID为50%。该小组建议，MIGS联合白内障摘除及人工晶状体植入术（CE-IOL）手术成功的定义为青光眼药物治疗较基线减少1种或更多，且眼压不升高，或眼压为21 mmHg或更低，较基线降低20%或更多，同时不增加青光眼药物使用、不进行额外的激光或切开性青光眼手术、无光感视力丧失或低眼压。MIGS联合CE-IOL手术2年成功累积概率的建议MCID为65%。财务披露：本文末尾的脚注和披露中可能会有专有或商业披露信息。
