A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION.

Markowitz, Samuel N; Devenyi, Robert G; Munk, Marion; Croissant, Cindy L; Tedford, Stephanie E; Rückert, Rene; Walker, Michael G; Patino, Beatriz E; Chen, Lina; Nido, Monica; Tedford, Clark E (2019). A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION. (In Press). Retina - the journal of retinal and vitreous diseases Lippincott, Williams & Wilkins 10.1097/IAE.0000000000002632

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology

UniBE Contributor:

Munk, Marion

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0275-004X

Publisher:

Lippincott, Williams & Wilkins

Language:

English

Submitter:

Marion Munk

Date Deposited:

28 Aug 2019 15:06

Last Modified:

22 Oct 2019 21:21

Publisher DOI:

10.1097/IAE.0000000000002632

PubMed ID:

31404033

BORIS DOI:

10.7892/boris.132625

URI:

https://boris.unibe.ch/id/eprint/132625

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