特别评论: 报道临床终点在研究的微创性玻璃眼外科手术
Steven J Gedde1, Kateki Vinod2, Eileen C Bowden3
1Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Ophthalmology
|August 10, 2024
概括
标准化对最小侵入性玻璃眼手术 (MIGS) 的结果至关重要. 专家一致认为,独立MIGS的成功率为50%,MIGS与白内障手术相结合的成功率为65%,在两年内.
科学领域:
- 眼科医生 眼科 眼科
- 手术创新 在外科创新.
- 临床试验设计 临床试验设计
背景情况:
- 最少侵入性玻璃眼手术 (MIGS) 提供了一种安全有效的治疗选择.
- 越来越多地使用MIGS需要标准化的结果测量来进行可靠的比较.
- 定义超出统计学意义的临床意义的结果对于患者的利益至关重要.
研究的目的:
- 建立专家对MIGS手术临床重要差异最小值 (MCID) 的共识.
- 为MIGS临床研究推标准化初级疗效终点.
- 确定独立MIGS和与白内障手术结合的MIGS手术成功的标准.
主要方法:
- 来自美国眼科医生学会眼科医生青光眼偏好实践模式委员会®的专家共识.
- 建议使用卡普兰-梅尔生存分析来计算2年后成功的累积概率.
- 定义手术成功标准,包括眼内压力 (IOP) 降低和药物改变.
主要成果:
- 建议在2年内独立MIGS成功的MCID为50%.
- 建议MIGS与白内障提取 (CE-IOL) 结合的MCID在2年后的成功率为65%.
- 定义的成功指标包括内血压≤21mmHg,内血压降低≥20%,不增加药物或进一步手术.
结论:
- 标准化终点和MCID增强了对MIGS研究结果的解释.
- 拟议的MCID值为评估MIGS结果的意义提供了基准.
- 这些建议支持基于证据的采用和推进MIGS程序.
相关概念视频
01:28Angle Closure Glaucoma: Treatment
459
Angle-closure glaucoma, or closed-angle glaucoma, is an eye condition where the iris bulges out and blocks the iridocorneal angle, resulting in a buildup of aqueous humor and increased intraocular pressure. Immediate medical attention is necessary due to the sudden onset of symptoms. The treatment for angle-closure glaucoma includes short-term and long-term approaches. Short-term treatment involves using eye drops like pilocarpine to lower intraocular pressure by increasing aqueous humor...
459
01:25Glaucoma: Overview
530
Glaucoma is an eye condition characterized by increased intraocular pressure that damages the retina and optic nerve, leading to irreversible blindness if left untreated. The human eye has various components, including the cornea, iris, pupil, lens, and optic nerve. Aqueous humor is secreted by the epithelium of the ciliary body in the posterior chamber and flows through the trabecular meshwork and canal of Schlemm, maintaining normal intraocular pressure. The trabecular meshwork and the canal...
530
01:27Open Angle Glaucoma: Treatment
413
In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...
Drugs such as carbonic anhydrase inhibitors, α2- and...
413