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低水平光疗在白内障手术前后预防术后干眼的疗效:一项前瞻性随机双盲对照临床试验。

Outcomes of low-level light therapy before and after cataract surgery for the prophylaxis of postoperative dry eye: a prospective randomised double-masked controlled clinical trial.

机构信息

Department of Ophthalmology, Magna Graecia University of Catanzaro, Catanzaro, Italy

Eye Clinic, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.

出版信息

Br J Ophthalmol. 2024 Jul 23;108(8):1172-1176. doi: 10.1136/bjo-2023-323920.

Abstract

BACKGROUND

Despite increasing evidence shows that optimising ocular surface before cataract surgery is fundamental in patients with pre-existing dry eye disease (DED) to achieve the desired postoperative outcomes, the prophylactic treatment of healthy patients undergoing surgery aiming at preventing iatrogenic DED is worth investigating.

METHODS

This was a prospective, interventional, randomised, controlled, double-masked clinical trial. Patients were randomly assigned 1:1 to receive either low-level light therapy (LLLT) or sham treatment (LLLT with a power output <30%). Patients underwent two treatment sessions: 7±2 days before cataract surgery (T0) and 7±2 days after (T1). Outcome measures evaluated 30±4 days after surgery (T2) included Ocular Surface Disease Index (OSDI) questionnaire, non-invasive break-up time (NIBUT), tear meniscus height, meibomian gland loss (MGL) and redness score.

RESULTS

Out of 153 patients randomised to receive LLLT (n=73) or sham treatment (n=80), 131 (70 men, 61 women, mean age 73.53±7.29 years) completed regularly the study. Patients treated with LLLT had significantly lower OSDI scores compared with controls at T1 and T2 (respectively, 7.2±8.8 vs 14.8±13.0 and 9.0±9.0 vs 18.2±17.9; both p<0.001), higher NIBUT values at T2 (12.5±6.6 vs 9.0±7.8; p=0.007) and lower MGL Meiboscore values at T1 (1.59±0.70 vs 1.26±0.69; p=0.008). Unlike controls, patients treated with LLLT had significantly lower OSDI scores and higher NIBUT values at T2 compared with T0 (respectively, 9.0±9.0 vs 21.2±16.1; p<0.001 and 12.5±6.6 vs 9.7±7.2; p=0.007).

CONCLUSION

Two sessions of LLLT performed before and after cataract surgery were effective in ameliorating tear film stability and ocular discomfort symptoms.

TRIAL REGISTRATION NUMBER

NCT05754437.

摘要

背景

尽管越来越多的证据表明,对于患有预先存在的干眼(DED)的患者,在白内障手术前优化眼表至关重要,以实现预期的术后效果,但对接受手术的健康患者进行预防性治疗以预防医源性 DED 值得研究。

方法

这是一项前瞻性、干预性、随机、对照、双盲临床试验。患者被随机分配 1:1 接受低水平光疗(LLLT)或假治疗(LLLT 输出功率<30%)。患者接受两次治疗:白内障手术前 7±2 天(T0)和手术后 7±2 天(T1)。术后 30±4 天(T2)评估的结局测量包括眼表疾病指数(OSDI)问卷、非侵入性泪膜破裂时间(NIBUT)、泪膜高度、睑板腺缺失(MGL)和发红评分。

结果

在随机接受 LLLT(n=73)或假治疗(n=80)的 153 名患者中,131 名(70 名男性,61 名女性,平均年龄 73.53±7.29 岁)定期完成了研究。与对照组相比,接受 LLLT 治疗的患者在 T1 和 T2 时的 OSDI 评分明显更低(分别为 7.2±8.8 vs 14.8±13.0 和 9.0±9.0 vs 18.2±17.9;均 p<0.001),T2 时 NIBUT 值更高(12.5±6.6 vs 9.0±7.8;p=0.007),T1 时 MGL Meiboscore 值更低(1.59±0.70 vs 1.26±0.69;p=0.008)。与对照组不同,接受 LLLT 治疗的患者与 T0 相比,在 T2 时 OSDI 评分和 NIBUT 值明显更低(分别为 9.0±9.0 vs 21.2±16.1;p<0.001 和 12.5±6.6 vs 9.7±7.2;p=0.007)。

结论

白内障手术前后进行两次 LLLT 治疗可有效改善泪膜稳定性和眼不适症状。

试验注册号

NCT05754437。

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