Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.
Department of Ophthalmology, University Health Network, Toronto, Ontario, Canada.
Retina. 2020 Aug;40(8):1471-1482. doi: 10.1097/IAE.0000000000002632.
The LIGHTSITE I study investigated the efficacy and safety of photobiomodulation (PBM) treatment in subjects with dry age-related macular degeneration.
Thirty subjects (46 eyes) were treated with the Valeda Light Delivery System, wherein subjects underwent two series of treatments (3× per week for 3-4 weeks) over 1 year. Outcome measures included best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments.
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) and Month 7 (M7). Approximately 50% of PBM-treated subjects showed improvement of ≥5 letters versus 13.6% in sham-treated subjects at M1. High responding subjects (≥5-letter improvement) in the PBM-treated group showed a gain of 8 letters after initial treatment (P < 0.01) and exhibited earlier stages of age-related macular degeneration disease. Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P < 0.05). No device-related adverse events were reported.
Photobiomodulation treatment statistically improved clinical and anatomical outcomes with more robust benefits observed in subjects with earlier stages of dry age-related macular degeneration. Repeated PBM treatments are necessary to maintain benefits. These pilot findings support previous reports and suggest the utility of PBM as a safe and effective therapy in subjects with dry age-related macular degeneration.
LIGHTSITE I 研究调查了光生物调节（PBM）治疗干性年龄相关性黄斑变性患者的疗效和安全性。
30 名受试者（46 只眼）接受了 Valeda 光输送系统治疗，其中受试者在 1 年内接受了两系列治疗（每周 3 次，持续 3-4 周）。疗效评估包括最佳矫正视力、对比敏感度、微视野计、中心玻璃膜疣体积和玻璃膜疣厚度以及生活质量评估。
光生物调节治疗组在第 1 个月（M1）和第 7 个月（M7）每次治疗系列结束后立即显示最佳矫正视力平均字母评分提高 4 个字母。与假治疗组相比，约 50%的 PBM 治疗组受试者在 M1 时改善≥5 个字母，而假治疗组仅为 13.6%。PBM 治疗组中高反应（≥5 个字母改善）受试者在初始治疗后获得了 8 个字母的提高（P < 0.01），并且表现出更早期的年龄相关性黄斑变性疾病。观察到对比敏感度、中心玻璃膜疣体积、中心玻璃膜疣厚度和生活质量的统计学显著改善（P < 0.05）。未报告与设备相关的不良事件。
光生物调节治疗在统计学上改善了临床和解剖学结果，在更早期的干性年龄相关性黄斑变性患者中观察到更显著的益处。需要重复进行 PBM 治疗以维持益处。这些初步研究结果支持了之前的报告，并表明 PBM 作为一种安全有效的干性年龄相关性黄斑变性治疗方法具有实用性。
