一项双掩盖,随机,假对照的单中心研究,具有光生物调节,用于处理干燥年龄相关的黄斑变性。
摘要来源:
endina。 2019年8月9日。EPUB 2019年8月9日。PMID: 314040404033 3140404033 Devenyi, Marion R Munk, Cindy L Croissant, Stephanie E Tedford, Rene Rückert, Michael G Walker, Beatriz E Patino, Lina Chen, Monica Nido, Clark E Tedford
Article Affiliation:Samuel N Markowitz
Abstract:PURPOSE: The LIGHTSITE I study investigated the efficacy and safety of photobiomodulation (PBM) treatment in subjects with dry age-related macular degeneration.
METHODS: Thirty subjects (46 eyes) were treated with the Valeda Light Delivery System, wherein subjects underwent two一年的一系列治疗(每周3×每周3-4周)。 Outcome measures included best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments.
RESULTS: Photobiomodulation-treated subjects showed a best-corrected visual acuity mean letter score gain of 4 letters immediately after each treatment series at Month 1 (M1)和第7个月(M7)。在M1时,在假治疗的受试者中,大约50%的PBM治疗受试者显示出≥5个字母,而13.6%。 PBM处理组的高反应受试者(≥5个字母的改善)显示初次治疗后8个字母的增益(P <0.01),并且表现出与年龄相关的黄斑变性疾病的早期阶段。观察到对比度灵敏度,中央drusen体积,中央drusen厚度和生活质量的统计显着改善(p <0.05)。没有与设备相关的不利前夕报告了NT。重复的PBM治疗对于维持利益是必要的。这些试点调查结果支持先前的报告,并提出PBM作为与干燥年龄相关的黄斑变性受试者的安全有效疗法的实用性。