Chen Kai-Yang, Lee Hung Kuan, Chan Hoi-Chun, Chan Chi-Ming
School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
School of Pharmacy, China Medical University, Taichung, Taiwan.
Ophthalmol Ther. 2025 May;14(5):969-987. doi: 10.1007/s40123-025-01119-w. Epub 2025 Mar 16.
This systematic review and meta-analysis compares the complications and effects of photobiomodulation (PBM) therapy with sham treatment in patients with age-related macular degeneration (AMD). AMD is a leading cause of visual impairment in older adults, with current treatments primarily focusing on symptom management. PBM therapy is emerging as a potential intervention to improve clinical and anatomical outcomes in patients with AMD, necessitating a comparative analysis with sham treatment to determine its efficacy and safety.
A systematic search was conducted across PubMed/Medline, Google Scholar and the Cochrane Library from inception to January 13, 2025. Randomised controlled trials (RCTs) meeting predefined inclusion criteria were selected. Meta-analysis employed random-effects models. The risk of bias in the included studies was assessed using Cochrane tools.
A total of six studies, comprising 360 patients and 477 eyes, focused on PBM for dry AMD. Five studies were eligible for meta-analysis. Best-corrected visual acuity (BCVA) showed no significant improvement with PBM (SMD - 0.30, 95% CI - 0.85 to 0.26, p = 0.30), with high heterogeneity (I = 83%). Macular drusen volume also showed no significant change (SMD - 0.08, 95% CI - 0.52 to 0.37, p = 0.74), with moderate heterogeneity (I = 48%). A single study reported no significant effect on geographic atrophy (SMD - 0.28, 95% CI - 1.26 to 0.71, p = 0.58). Central subfield thickness (SMD 0.11, 95% CI - 0.25 to 0.47, p = 0.58) and microperimetry (SMD - 0.02, 95% CI - 0.48 to 0.44, p = 0.94) also showed no significant changes. The adverse events analysis indicated a statistically significant increase in adverse events in the sham group within 6 months (RR 0.48, 95% CI 0.29-0.82, p = 0.007), while the overall effect on adverse events was non-significant (RR 1.04, 95% CI 0.51-2.12, p = 0.91, I = 78%). Qualitative analysis suggested that PBM might enhance quality of life and clinical and anatomical outcomes compared to sham treatment.
This meta-analysis suggests that, to date, there are no significant clinical benefits of PBM therapy for patients with AMD. Further long-term studies are needed to establish its clinical relevance and safety profile.
本系统评价和荟萃分析比较了光生物调节（PBM）疗法与假治疗对年龄相关性黄斑变性（AMD）患者的并发症及效果。AMD是老年人视力损害的主要原因，目前的治疗主要集中在症状管理。PBM疗法正在成为一种改善AMD患者临床和解剖学结局的潜在干预措施，因此需要与假治疗进行比较分析以确定其疗效和安全性。
从创刊至2025年1月13日，在PubMed/Medline、谷歌学术和考克兰图书馆进行了系统检索。选择符合预定义纳入标准的随机对照试验（RCT）。荟萃分析采用随机效应模型。使用考克兰工具评估纳入研究的偏倚风险。
共有6项研究，涉及360例患者和477只眼，聚焦于PBM治疗干性AMD。5项研究符合荟萃分析的条件。最佳矫正视力（BCVA）在PBM治疗后无显著改善（标准化均数差[SMD] -0.30，95%置信区间[CI] -0.85至0.26，p = 0.30），异质性高（I² = 83%）。黄斑玻璃疣体积也无显著变化（SMD -0.08，95%CI -0.52至0.37，p = 0.74），异质性中等（I² = 48%）。一项研究报告对地图样萎缩无显著影响（SMD -0.28，95%CI -1.26至0.71，p = 0.58）。中心子野厚度（SMD 0.11，95%CI -0.25至0.47，p = 0.58）和微视野检查（SMD -0.02，95%CI -0.48至0.44，p = 0.94）也无显著变化。不良事件分析表明，假治疗组在6个月内不良事件有统计学意义的增加（风险比[RR] 0.48，95%CI 0.29 - 0.82，p = 0.007），而对不良事件的总体影响无统计学意义（RR 1.04，95%CI 0.51 - 2.12，p = 0.91，I² = 78%）。定性分析表明，与假治疗相比，PBM可能提高生活质量以及临床和解剖学结局。
这项荟萃分析表明，迄今为止，PBM疗法对AMD患者没有显著的临床益处。需要进一步的长期研究来确定其临床相关性和安全性。
