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对玻璃体飞蚊症采用YAG激光玻璃体溶解术与虚假对照YAG玻璃体溶解术:一个随机临床试验

Shah, C.P., Heier, J.S.

期刊名称:JAMA Ophthalmology

卷期:2017年第135卷第9期

关键词:
玻璃体 激光

摘要

摘要:重要性:玻璃体飞蚊症是常见的,可以使视觉质量恶化。 YAG玻璃体溶解术是一种未经检验的治疗飞蚊症的方法。目的:旨在评估YAG激光玻璃体溶解术与虚假对照YAG玻璃体溶解术治疗玻璃体脱离术后症状性飞蚊症。设计,设置和研究对象:从2015325日至201683日进行了一项单中心,盲性,假手术对照随机临床试验,对在一家私人眼科医院治疗的52例(36例和16例对照)的52只眼中进行了分析。措施:患者随机分配为YAG激光玻璃溶解分析或假YAG(对照)治疗。主要预后指标:主要6个月指标为使用10分视觉障碍评分,5级定性量表和国家眼科研究所视觉功能调查问卷25NEI VFQ-25)检测的主观变化,从0%至100 。次要指标包括通过彩色眼底摄影和早期治疗糖尿病视网膜病变研究最佳矫正视力的盲性分级评估的客观改变。结果:这项研究招募了52例症状性飞蚊症患者(52眼,1735女,51白人,1亚裔),(YAG激光组平均[SD]年龄,61.4 [8.0]岁,假手术组为61.1 [6.6]岁)。 YAG激光组(54%)的症状改善较对照组(9%)大(差异45; 95CI25-64; P <0.001)。在YAG激光组中,10分视力障碍评分提高了3.2 vs 0.1(假手术组)(差异为-3.0; 95CI-4.3-1.7; P <0.001)。 YAG激光组共有19名患者(53%)报告显着或完全改善,假手术组为0(差异53%,95CI36-69%,P <0.001)。与假手术组相比, NEI VFQ-25显示YAG激光组的一般视力(差异16.3; 95CI0.9-31.7; P = 0.04),外周视力(差异11.6; 95CI0.8-22.4; P = 0.04 ),作用困难(差异,17.3; 95CI8.0-26.6; P <0.001)及依赖性改善(差异,5.6; 95CI0.5-10.8; P = 0.03)。 YAG激光组最佳矫正视力为-0.2个字母变化,假手术组变化为-0.6个字母(差异为0.4; 95CI-6.55.3; P = .94)。组间不良事件无差异。结论与意义:YAG激光玻璃体溶解术主观改善了Weiss环相关症状,客观改善了Weiss环外观。对这些结果的更大信心可能来自较长时间的更大的验证性研究。试验注册:clinicaltrials.gov NCT02897583

Importance:Vitreous floaters are common and can worsen visual quality. YAG vitreolysis is an untested treatment for floaters.Objective:To evaluate YAG laser vitreolysis vs sham vitreolysis for symptomatic Weiss ring floaters from posterior vitreous detachment.Design, Setting, and Participants:This single-center, masked, sham-controlled randomized clinical trial was performed from March 25, 2015, to August 3, 2016, in 52 eyes of 52 patients (36 cases and 16 controls) treated at a private ophthalmology practice.Interventions:Patients were randomly assigned to YAG laser vitreolysis or sham YAG (control).Main Outcomes and Measures:Primary 6-month outcomes were subjective change measured from 0% to 100% using a 10-point visual disturbance score, a 5-level qualitative scale, and National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary outcomes included objective change assessed by masked grading of color fundus photography and Early Treatment Diabetic Retinopathy Study best-corrected visual acuity.Results:Fifty-two patients (52 eyes; 17 men and 35 women; 51 white and 1 Asian) with symptomatic Weiss rings were enrolled in the study (mean [SD] age, 61.4 [8.0] years for the YAG laser group and 61.1 [6.6] years for the sham group). The YAG laser group reported greater symptomatic improvement (54%) than controls (9%) (difference, 45%; 95% CI, 25%-64%; P < .001). In the YAG laser group, the 10-point visual disturbance score improved by 3.2 vs 0.1 in the sham group (difference, -3.0; 95% CI, -4.3 to -1.7; P < .001). A total of 19 patients (53%) in the YAG laser group reported significantly or completely improved symptoms vs 0 individuals in the sham group (difference, 53%; 95% CI, 36%-69%, P < .001). Compared with sham, NEI VFQ-25 revealed improved general vision (difference, 16.3; 95% CI, 0.9-31.7; P = .04), peripheral vision (difference, 11.6; 95% CI, 0.8-22.4; P = .04), role difficulties (difference, 17.3; 95% CI, 8.0-26.6; P < .001), and dependency (difference, 5.6; 95% CI, 0.5-10.8; P = .03) among the YAG laser group. Best-corrected visual acuity changed by -0.2 letters in the YAG laser group and by -0.6 letters in sham group (difference, 0.4; 95% CI, -6.5 to 5.3; P = .94). No differences in adverse events between groups were identified.Conclusions and Relevance:YAG laser vitreolysis subjectively improved Weiss ring-related symptoms and objectively improved Weiss ring appearance. Greater confidence in these outcomes may result from larger confirmatory studies of longer duration.Trial Registration:clinicaltrials.gov NCT02897583.


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