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便携式 445nm 激光治疗与强脉冲光治疗干眼症的疗效比较:一项前瞻性随机初步研究。

Efficacy of Portable 445 nm Laser Versus Intense Pulsed Light Treatment for Dry Eye: A Prospective Randomized Pilot Study.

机构信息

Sussex Premier Hospital, St Leonards-on-Sea, United Kingdom.

VBS Medical Ltd., London, United Kingdom.

出版信息

Photobiomodul Photomed Laser Surg. 2023 Mar;41(3):120-124. doi: 10.1089/photob.2022.0102.

DOI:10.1089/photob.2022.0102
PMID:36927052
Abstract

The aim of the study is to evaluate the efficacy of intense pulsed light (IPL) compared with a portable 445 nm laser device in the treatment of dry eye. Our hypothesis was that IPL and 445 nm laser can provide equal reduction of symptoms for patients with dry eye disease. Participants provided written informed consent as per the Helsinki declaration before a baseline testing (visit 1). All participants completed four in-clinic study visits and one telephone call over the course of ∼4 months. The patients were evaluated at baseline and received the first treatment (visit 1) at the same visit. Thereafter, treatment was repeated every 2 weeks until four treatments had been administered (visits 2-4). The evaluation of dry eye included the following tests for both eyes: tear break-up time (TBUT), in seconds, taken in three measurements using a timer; corneal fluorescein staining (CFS); and lissamine green (grading 0-5 as per Oxford grading system). Other tests included visual acuity and the measurement of intraocular pressure. A full medical history and current ocular and systemic medications were obtained. All participants completed the Dry Eye Questionnaire (DEQ5), as per DEWS II, at each visit, as well as during the final telephone assessment ∼2 months after their fourth treatment. Twenty-eight eyes of 14 patients were included in the study. The eyes were randomized with 14 eyes in each group receiving either 445 nm laser or IPL. The group included 10 female and 4 male participants with average age of 64.8 years (standard deviation 13.9). The primary outcome measures of TBUT, CFS, and the DEQ5 questionnaire were statistically significantly improved. TBUT IPL versus 445 nm laser  = 0.0097 versus 0.0115, CFS IPL versus 445 nm laser  = 0.0027 versus 0.0003. The questionnaire did not discriminate between the two methods but also showed highly statistically significant improvement  = 0.0001. The portable 445 nm laser and IPL were equally effective in the treatment of dry eye in this cohort. No significant adverse events were noted in either treatment group. K-Laser Blue can be considered as a substitute for IPL treatment for dry eye.

摘要

本研究旨在评估强脉冲光(IPL)与便携式 445nm 激光设备治疗干眼症的疗效。我们的假设是 IPL 和 445nm 激光可以为干眼症患者提供同等的症状缓解。

参与者在基线测试(第 1 次就诊)前根据赫尔辛基宣言签署了书面知情同意书。所有参与者在大约 4 个月的时间内完成了 4 次门诊就诊和 1 次电话随访。患者在基线时接受评估,并在同一就诊时接受第 1 次治疗(第 1 次就诊)。此后,每 2 周重复治疗,直到进行了 4 次治疗(第 2-4 次就诊)。干眼症的评估包括以下测试:泪膜破裂时间(TBUT),使用秒表进行三次测量;角膜荧光素染色(CFS);以及丽丝胺绿(根据牛津分级系统分级 0-5)。其他测试包括视力和眼压测量。获取完整的病史和当前眼部及全身用药情况。所有参与者在每次就诊时都按照 DEWS II 完成干眼问卷(DEQ5),并在第四次治疗后大约 2 个月的最后一次电话评估时完成。

本研究纳入了 14 名患者的 28 只眼。眼睛随机分为两组,每组 14 只眼,分别接受 445nm 激光或 IPL 治疗。该组包括 10 名女性和 4 名男性参与者,平均年龄为 64.8 岁(标准差 13.9)。TBUT、CFS 和 DEQ5 问卷的主要结局测量指标均有统计学意义上的显著改善。TBUT IPL 与 445nm 激光相比  = 0.0097 对 0.0115,CFS IPL 与 445nm 激光相比  = 0.0027 对 0.0003。问卷没有区分两种方法,但也显示出高度统计学意义上的显著改善  = 0.0001。在本队列中,便携式 445nm 激光和 IPL 治疗干眼症同样有效。在任何治疗组中均未观察到明显的不良事件。K-Laser Blue 可作为 IPL 治疗干眼症的替代方法。

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