光生物调节疗法对早中期年龄相关性黄斑变性的短期疗效:PBM4AMD研究
Short-term efficacy of photobiomodulation in early and intermediate age-related macular degeneration: the PBM4AMD study.
作者信息
Nassisi Marco, Mainetti Claudia, Paparella Giorgia Rosapia, Belloni Baroni Luca, Milella Paolo, Leone Gaia, Galli Davide, Pozzo Giuffrida Francesco, Dell'Arti Laura, Mapelli Chiara, Casalino Giuseppe, Viola Francesco
机构信息
Ophthalmology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
出版信息
Eye (Lond). 2024 Dec;38(18):3467-3472. doi: 10.1038/s41433-024-03326-4. Epub 2024 Sep 14.
OBJECTIVES
This independent prospective study evaluated the short-term effects and safety of photobiomodulation (PBM) in early and intermediate age-related macular degeneration.
METHODS
patients were treated with PBM in one eye. Functional parameters and drusen volume were measured at one (W4), three- (W12) and six-months (W24) after PBM.
RESULTS
The study included 38 subjects who completed the PBM protocol. Two patients developed macular neovascularization during the study period. Best corrected visual acuity improved from 77.82 ± 5.83 ETDRS letters at baseline to 82.44 ± 5.67 at W12 (p < 0.01), then declined to 80.05 ± 5.79 at W24 (p < 0.01 vs. baseline). Low luminance visual acuity showed a similar pattern, improving from 61.18 ± 8.58 ETDRS letters at baseline to 66.33 ± 8.55 at W12 (p < 0.01), and decreasing to 62.05 ± 9.71 at W24 (p = 0.02). Contrast sensitivity improved at W12 (20.11 ± 9.23 ETDRS letters, p < 0.01), but returned to baseline by W24 (16.45 ± 9.12, p = 0.5). Scotopic microperimetry showed a decrease in mean absolute retinal sensitivity from 9.24 ± 3.44 dB to 7.47 ± 4.41 dB at W24 (p < 0.01), while relative sensitivity decreased only at W24 (p = 0.04). Drusen volume decreased at W4 (0.018 ± 0.009 mm3, p < 0.01) and W12 (0.017 ± 0.009 mm3, p < 0.01), with a slight increase at W24 (0.019 ± 0.012 mm3, p = 0.154).
CONCLUSIONS
PBM resulted in temporary improvements in visual function and a reduction in drusen volume, but these effects were not sustained at six months. The long-term efficacy and impact on disease progression are uncertain, necessitating further research to confirm these findings and determine optimal patient selection.
目的
本独立前瞻性研究评估了光生物调节(PBM)对早期和中期年龄相关性黄斑变性的短期疗效及安全性。
方法
对患者的一只眼睛进行PBM治疗。在PBM治疗后1周(第4周)、3周(第12周)和6个月(第24周)测量功能参数和玻璃疣体积。
结果
该研究纳入了38名完成PBM方案的受试者。两名患者在研究期间发生了黄斑新生血管形成。最佳矫正视力从基线时的77.82±5.83 ETDRS字母提高到第12周时的82.44±5.67(p<0.01),然后在第24周下降至80.05±5.79(与基线相比p<0.01)。低亮度视力呈现相似模式,从基线时的61.18±8.58 ETDRS字母提高到第12周时的66.33±8.55(p<0.01),并在第24周降至62.05±9.71(p=0.02)。对比敏感度在第12周时提高(20.11±9.23 ETDRS字母,p<0.01),但在第24周时恢复到基线水平(16.45±9.12,p=0.5)。暗视微视野检查显示,在第24周时平均绝对视网膜敏感度从9.24±3.44 dB降至7.47±4.41 dB(p<0.01),而相对敏感度仅在第24周时下降(p=0.04)。玻璃疣体积在第4周(0.018±0.009 mm³,p<0.01)和第12周(0.017±0.009 mm³,p<0.01)时减小,在第24周时有轻微增加(0.019±0.012 mm³,p=0.154)。
结论
PBM可导致视觉功能暂时改善和玻璃疣体积减小,但这些效果在6个月时未持续。其长期疗效及对疾病进展的影响尚不确定,需要进一步研究以证实这些发现并确定最佳患者选择。