Randomized controlled trial2020Open access

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 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Independent funding
Government
National Eye Institute
Government
NEI NIH HHS
Grants
National Eye Institute (R43 EY025508)

Based on 2 listed funder(s).

Publication

Published
2019-08-11 · Retina · vol. 40 · issue 8 · pp. 1471–1482
Publisher
Lippincott Williams & Wilkins
Cited
119 citations · more than 96% of similar papers · 4.8× the field average
Impact
Top 10% most cited in its field
References
39 works
Access
Open access (hybrid journal) · CC-BY
Research areas
Laser Applications in Dentistry and Medicine · Retinal Diseases and Treatments · Ophthalmology and Visual Impairment Studies
Keywords
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 authors

From CA, CH, US

  • Samuel N. Markowitz · correspondingUniversity of Toronto
  • Robert G. Devenyi · correspondingUniversity Health Network; University of Toronto
  • Marion Ronit MunkUniversity Hospital of Bern
  • Cindy L. CroissantPeninsula Cancer Center
  • Stephanie E. TedfordPeninsula Cancer Center
  • René Rückert

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 via Europe PMC. Copyright remains with the authors or publisher (CC BY).

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