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随机的非劣势试验的直接选择性激光膜整形在开放角度的玻璃眼和眼睛高血压:光荣的

Gus Gazzard¹, Nathan Congdon², Augusto Azuara-Blanco³

¹NIHR Moorfields Biomedical Research Centre, and Moorfields Eye Hospital City Road Campus, London, UK; Institute of Ophthalmology, University College London, London, UK.

|May 11, 2025

概括

直接选择性激光斜视造形术 (DSLT) 在青光眼患者中显示了与传统选择性激光斜视造形术 (SLT) 相似的12个月内眼压 (IOP) 降低. 虽然没有达到6个月的非劣势目标,但DSLT是一种安全有效的第一线治疗选择.

科学领域:

眼科医生眼科眼科
青光眼治疗方法青光眼治疗方法
激光疗法是一种激光疗法.

背景情况:

不坚持局部药物治疗和有限的选择性激光轨道造形术 (SLT) 阻碍了对玻璃眼的有效管理.
直接选择性激光膜整形 (DSLT) 提供了一种自动化的,无镜的,非接触的,图像引导的替代方法来降低眼内压力 (IOP).

研究的目的:

将DSLT与常规SLT的疗效和安全性比较在患有开角玻璃眼 (OAG) 和眼高血压 (OHT) 的患者中.
评估DSLT与SLT在12个月内减少IOP方面的非劣势.

主要方法:

一个前性的,多中心的,随机的,受控的,评估者掩盖的非劣等性试验.
192名参与者 (OAG/OHT,年龄≥40) 被随机分配到DSLT (n=99) 或SLT (n=93).
内压在基线和手术后6个月和12个月被测量;不良事件被监测.

主要成果:

在6个月后,没有达到非劣势的主要终点 (平均IOP降低:DSLT -5.5 mmHg,SLT -6.2 mmHg;差异 -0.7 mmHg).
在12个月后,DSLT和SLT都实现了类似的平均IOP降低 (DSLT -3.2 mmHg,SLT -3.2 mmHg;差异为0.01 mmHg),符合非劣势标准.
安全性概况相似,眼部有轻微的不良事件;点状副膜出血在DSLT中更为频繁.

结论:

在6个月后,DSLT没有达到对SLT的统计非劣势,但在12个月后显示了持续的IOP降低.
DSLT耐受性很好,是早期青光眼治疗的可行,有效的替代方案,特别是在SLT的获取有限的情况下.

关键词:

直接选择性激光轨道造形术 (DSLT) 是一种直接选择性的激光轨道造形术.眼内压力 (IOP) 是指眼内压力.眼睛高血压 (OHT) 是指眼睛的高血压.视角开放的玻璃眼 (OAG)选择性激光椎造形术 (SLT) 是一种选择性激光椎造形术.

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