Abstract
INTRODUCTION: 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. METHODS: 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. RESULTS: 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(2) = 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(2) = 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(2) = 78%). Qualitative analysis suggested that PBM might enhance quality of life and clinical and anatomical outcomes compared to sham treatment. CONCLUSION: 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.