Evidence map›Paper›PMID 31404033›Full record

Trial reportRetina (Philadelphia, Pa.)2020

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

Samuel N Markowitz, Robert G Devenyi, Marion R Munk, Cindy L Croissant, Stephanie E Tedford, Rene Rückert, Michael G Walker, Beatriz E Patino, Lina Chen, Monica Nido and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Retina (Philadelphia, Pa.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Photobiomodulation for non-exudative age-related macular degeneration.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. The success-failure inversion in modern medicine.Frontiers in public health · 2026
    Article
  15. Rapid Macular Thinning as a Biomarker for Geographical Atrophy.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Samuel N MarkowitzDepartment of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.
Robert G DevenyiDepartment of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.
Marion R MunkDepartment of Ophthalmology, Inselspital University Hospital Bern, Bern, Switzerland.
Cindy L CroissantLumiThera Inc, Poulsbo, Washington.
Stephanie E TedfordLumiThera Inc, Poulsbo, Washington.
Rene RückertEyegnos Consulting, Bern, Switzerland; and.
Michael G WalkerWalker Bioscience, Carlsbad, California.
Beatriz E PatinoDepartment of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.
Lina ChenDepartment of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.
Monica NidoDepartment of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.
Clark E TedfordLumiThera Inc, Poulsbo, Washington.

Funding

A pilot clinical study to evaluate the use of photobiomodulation in patients with dry age-related macular degenerationR43EY025508 · NEI · LUMITHERA, INC. · PI TEDFORD, CLARK E · 2015 to 2017
$396k
NEI NIH HHS R43 EY025508
6 · The paper itself

Abstract

purposeThe LIGHTSITE I study investigated the efficacy and safety of photobiomodulation (PBM) treatment in subjects with dry age-related macular degeneration.

methodsThirty 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.

resultsPhotobiomodulation-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.

conclusionPhotobiomodulation 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.

Indexed as

Low-Level Light TherapyAgedAged, 80 and overContrast SensitivityDouble-Blind MethodFemaleGeographic AtrophyHumansMaleMiddle AgedProspective StudiesQuality of LifeRetinal DrusenSurveys and QuestionnairesTreatment OutcomeVisual Acuity

Identifiers

PMID31404033
PMCPMC7392581

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.