A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION
Markowitz SN, Devenyi RG, Munk MR, Croissant CL, Tedford SE, Rückert R, Walker MG, Patino BE, Chen L, Nido M, Tedford CE
Retina (Philadelphia, Pa.) · 86 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Eye Institute
- Gobierno
- NEI NIH HHS
- Subvenciones
- National Eye Institute (R43 EY025508)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2019-08-11 · Retina · vol. 40 · número 8 · págs. 1471–1482
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 119 citas · más que el 96% de estudios similares · 4.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 39 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Laser Applications in Dentistry and Medicine · Retinal Diseases and Treatments · Ophthalmology and Visual Impairment Studies
- Palabras clave
- Drusen, Microperimetry, Medicine, Macular degeneration, Ophthalmology, Visual acuity, Adverse effect, Internal medicine
- MeSH
- humans, retinal drusen, treatment outcome, prospective studies, double-blind method, contrast sensitivity, visual acuity, visual fields, quality of life, aged, aged, 80 and over, middle aged, female, male, geographic atrophy, visual field tests, surveys and questionnaires, low-level light therapy
11 autores
- Samuel N. Markowitz🇨🇦 · autor de correspondenciaUniversity of Toronto
- Robert G. Devenyi🇨🇦 · autor de correspondenciaUniversity Health Network; University of Toronto
- Marion Ronit Munk🇨🇭University Hospital of Bern
- Cindy L. Croissant🇺🇸Peninsula Cancer Center
- Stephanie E. Tedford🇺🇸Peninsula Cancer Center
- René Rückert
- Michael G. Walker🇺🇸 · autor de correspondenciaWalker (United States)
- Beatriz Patiño🇨🇦 · autor de correspondenciaUniversity of Toronto
- Lina Chen🇨🇦 · autor de correspondenciaUniversity of Toronto
- Monica Daibert Nido🇨🇦 · autor de correspondenciaUniversity of Toronto
- Clark E. Tedford🇺🇸Peninsula Cancer Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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