A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION. Issue 8 (August 2020)

• Record Type: Journal Article
• Authors: Markowitz, Samuel N.; Devenyi, Robert G.; Munk, Marion R.; Croissant, Cindy L.; Tedford, Stephanie E.; Rückert, Rene; Walker, Michael G.; Patino, Beatriz E.; Chen, Lina; Nido, Monica; Tedford, Clark E.
• Is Part Of: Retina. Volume 40:Issue 8(2020)
• Publication Date: 2020-08
• Subjects: dry age-related macular degeneration -- drusen -- light-emitting diode -- low-level light therapy -- photobiomodulation -- vision loss -- best-corrected visual acuity -- mitochondria -- contrast sensitivity; Retina -- Diseases -- Periodicals; Retinal Diseases; Vitreous Body; 617.735
• DOI: 10.1097/IAE.0000000000002632
• Languages: English
• ISSNs: 0275-004X

Abstract

Abstract : Purpose: The LIGHTSITE I study investigated the efficacy and safety of photobiomodulation (PBM) treatment in subjects with dry age-related macular degeneration. Methods: 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. Results: 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. Conclusion: 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. Abstract : Photobiomodulation treatment in a randomized, sham-controlled, single-center, double-masked study conducted in 46 eyes of patients with dry age-related macular degeneration significantly improved functional (visual acuity and contrast sensitivity) and anatomical (drusen volume and central drusen thickness) outcomes. Patient improvements were reported in the VFQ-25 assessing activities of daily living.