Evidence map›Paper›PMID 32661752›Full record

Trial reportDiabetologia2020

Preclinical and clinical studies of photobiomodulation therapy for macular oedema.

Weiyong Shen, Kelvin Yi Chong Teo, John P M Wood, Anagha Vaze, Glyn Chidlow, Jack Ao, So-Ra Lee, Michelle X Yam, Elisa E Cornish, Samantha Fraser-Bell and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02181400 (Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
1.9field-weighted citation impact, top 11% of its field
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.

NCT02181400 nacompletednot on this map

Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

TypeinterventionalSponsorUniversity of SydneyRan2016 to 2019Enrolled21ConditionsDiabetic Macular OedemaArmsEllex Integre NIR laser
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 37 citations in OpenAlex.

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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

12 authors at 3 institutions in 2 countries.

Weiyong ShenSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia.
Kelvin Yi Chong TeoSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia.
John P M WoodDepartment of Ophthalmology and Visual Sciences, Adelaide Health and Medical Sciences Building, University of Adelaide, Adelaide, SA, 5000, Australia.
Anagha VazeSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia.
Glyn ChidlowDepartment of Ophthalmology and Visual Sciences, Adelaide Health and Medical Sciences Building, University of Adelaide, Adelaide, SA, 5000, Australia.
Jack AoDepartment of Ophthalmology and Visual Sciences, Adelaide Health and Medical Sciences Building, University of Adelaide, Adelaide, SA, 5000, Australia.
So-Ra LeeSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia.
Michelle X YamSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia.
Elisa E CornishSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia.
Samantha Fraser-BellSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia.
Robert J CassonDepartment of Ophthalmology and Visual Sciences, Adelaide Health and Medical Sciences Building, University of Adelaide, Adelaide, SA, 5000, Australia. casson.robert@gmail.com.
Mark C GilliesSave Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, 8 Macquarie Street, Sydney, NSW, 2000, Australia. mark.gillies@sydney.edu.au.
University of Sydney · AUUniversity of Adelaide · AUSydney Hospital · AU

Funding

National Health and Medical Research Council of Australia APP1103406
6 · The paper itself

Abstract

aims/hypothesisDiabetic macular oedema (DME) is the leading cause of visual impairment in people with diabetes. Intravitreal injections of vascular endothelial growth factor inhibitors or corticosteroids prevent loss of vision by reducing DME, but the injections must be given frequently and usually for years. Here we report laboratory and clinical studies on the safety and efficacy of 670 nm photobiomodulation (PBM) for treatment of centre-involving DME.

methodsThe therapeutic effect of PBM delivered via a light-emitting diode (LED) device was tested in transgenic mice in which induced Müller cell disruption led to photoreceptor degeneration and retinal vascular leakage. We also developed a purpose-built 670 nm retinal laser for PBM to treat DME in humans. The effect of laser-delivered PBM on improving mitochondrial function and protecting against oxidative stress was studied in cultured rat Müller cells and its safety was studied in pigmented and non-pigmented rat eyes. We then used the retinal laser to perform PBM in an open-label, dose-escalation Phase IIa clinical trial involving 21 patients with centre-involving DME. Patients received 12 sessions of PBM over 5 weeks for 90 s per treatment at a setting of 25, 100 or 200 mW/cm

resultsLED-delivered PBM enhanced photoreceptor mitochondrial membrane potential, protected Müller cells and photoreceptors from damage and reduced retinal vascular leakage resulting from induced Müller cell disruption in transgenic mice. PBM delivered via the retinal laser enhanced mitochondrial function and protected against oxidative stress in cultured Müller cells. Laser-delivered PBM did not damage the retina in pigmented rat eyes at 100 mW/cm CONCLUSIONS/

interpretationPBM results in anatomical improvement of DME over 6 months and may represent a safe and non-invasive treatment. Further testing is warranted in randomised clinical trials.

trial registrationClinicalTrials.gov NCT02181400 Graphical abstract.

Indexed as

AgedAnimalsDiabetic RetinopathyEpendymoglial CellsFemaleHumansLow-Level Light TherapyMacular EdemaMaleMiceMice, TransgenicMiddle AgedMitochondriaOxidative StressRatsTomography, Optical CoherenceClinical trialDiabetic macular oedemaMüller cellPhotobiomodulationPhotoreceptorTransgenic mice

Identifiers

PMID32661752
OpenAlexW3040716207

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.