LIGHTSITE III

作者：David S. Boyer, Allen Y. H. Hu, David J. Warrow, Samantha Xavier, Víctor H. González, Eleonora Maries Lad, Richard B. Rosen, Diana Do, Todd E. Schneiderman, Allen Y. H. Hu, Marion Ronit Munk, Glenn J. Jaffe, Stephanie E. Tedford, Cindy L. Croissant, Michael G. Walker, René Rückert, Clark E. Tedford · 发表于：Retina · 年份：2023 · DOI：10.1097/iae.0000000000003980 · 被引用次数：76 · 研究领域：Laser Applications in Dentistry and Medicine、Retinal Diseases and Treatments、Ophthalmology and Visual Impairment Studies

PURPOSE: The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) age-related macular degeneration (AMD) using the LumiThera Valeda Light Delivery System. METHODS: LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were given multiwavelength PBM (590, 660, and 850 nm) or Sham treatment delivered in a series of nine sessions over 3 to 5 weeks every four months over 24 months. Subjects were assessed for efficacy and safety outcomes. Data from the 13-month analysis are presented in this report. RESULTS: A total of 100 subjects (148 eyes) with dry AMD were randomized. LIGHTSITE III met the primary efficacy best-corrected visual acuity endpoint with a significant difference between PBM (n = 91 eyes) and Sham (n = 54 eyes) groups (Between group difference: 2.4 letters (SE 1.15), CI: -4.7 to -0.1, P = 0.02) (PBM alone: 5.4 letters (SE 0.96), CI: 3.5 to 7.3, P < 0.0001; Sham alone: 3.0 letters (SE 1.13), CI: 0.7-5.2, P < 0.0001). The PBM group showed a significant decrease in new onset geographic atrophy ( P = 0.024, Fisher exact test, odds ratio 9.4). A favorable safety profile was observed. CONCLUSION: LIGHTSITE III provides a prospective, randomized, controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM therapy.