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Safety, tolerability, and short-term efficacy of low-level light therapy for dry age-related macular degeneration

dc.contributor.coauthorBorrelli, Enrico
dc.contributor.coauthorCoco, Giulia
dc.contributor.coauthorPellegrini, Marco
dc.contributor.coauthorMura, Marco
dc.contributor.coauthorCiarmatori, Nicolo
dc.contributor.coauthorScorcia, Vincenzo
dc.contributor.coauthorCarnevali, Adriano
dc.contributor.coauthorLucisano, Andrea
dc.contributor.coauthorBorselli, Massimiliano
dc.contributor.coauthorRossi, Costanza
dc.contributor.coauthorReibaldi, Michele
dc.contributor.coauthorRicardi, Federico
dc.contributor.coauthorVagge, Aldo
dc.contributor.coauthorNicolo, Massimo
dc.contributor.coauthorForte, Paolo
dc.contributor.coauthorCartabellotta, Antonio
dc.contributor.coauthorDemirel, Sibel
dc.contributor.coauthorYanik, Ozge
dc.contributor.coauthorBernabei, Federico
dc.contributor.coauthorRothschild, Pierre-Raphael
dc.contributor.coauthorFarrant, Sarah
dc.contributor.coauthorGiannaccare, Giuseppe
dc.contributor.departmentSchool of Medicine
dc.contributor.kuauthorHasanreisoğlu, Murat
dc.contributor.kuauthorKesim, Cem
dc.contributor.schoolcollegeinstituteSCHOOL OF MEDICINE
dc.date.accessioned2025-03-06T20:59:52Z
dc.date.issued2024
dc.description.abstractIntroductionPhotobiomodulation (PBM) has become a promising approach for slowing the progression of early and intermediate dry age-related macular degeneration (dAMD) to advanced AMD. This technique uses light to penetrate tissues and activate molecules that influence biochemical reactions and cellular metabolism. This preliminary analysis is aimed at assessing the safety, tolerability, and short-term effectiveness of the EYE-LIGHT (R) PBM treatment device in patients with dAMD.MethodsThe EYE-LIGHT (R) device employs two wavelengths, 590 nm (yellow) and 630 nm (red), in both continuous and pulsed modes. Patients over 50 years of age with a diagnosis of dAMD in any AREDS (Age-Related Eye Disease Study) category were randomly assigned to either the treatment group or the sham group. The treatment plan consisted of an initial cycle of two sessions per week for 4 weeks. Safety, tolerability, and compliance outcomes, along with functional and anatomical outcomes, were assessed at the end of the fourth month.ResultsThis preliminary analysis included data from 76 patients (152 eyes). All patients were fully compliant with treatment sessions, and only one fifth of patients treated with PBM reported mild ocular adverse events, highlighting exceptional results in terms of tolerability and adherence. Changes in best-corrected visual acuity (BCVA) from baseline to month 4 differed significantly between the sham and PBM-treated groups, favoring the latter, with a higher proportion achieving a gain of five or more letters post-treatment (8.9% vs. 20.3%, respectively;p = 0.043). No significant differences in central subfield thickness (CST) were observed between the two groups over the 4-month period. The study also found a statistically significant disparity in mean drusen volume changes from baseline to month 4 between the groups in favor of patients treated with PBM (p = 0.013).ConclusionThese preliminary results indicate that PBM treatment using the EYE-LIGHT (R) system is safe and well tolerated among patients with dAMD. Furthermore, both functional and anatomical data support the treatment's short-term efficacy.Trial RegistrationClinicalTrials.gov identifier NCT06046118.
dc.description.indexedbyWOS
dc.description.indexedbyScopus
dc.description.indexedbyPubMed
dc.description.publisherscopeInternational
dc.description.sponsoredbyTubitakEuN/A
dc.identifier.doi10.1007/s40123-024-01030-w
dc.identifier.eissn2193-6528
dc.identifier.issn2193-8245
dc.identifier.issue11
dc.identifier.quartileQ2
dc.identifier.scopus2-s2.0-85204117423
dc.identifier.urihttps://doi.org/10.1007/s40123-024-01030-w
dc.identifier.urihttps://hdl.handle.net/20.500.14288/27796
dc.identifier.volume13
dc.identifier.wos1312057700002
dc.keywordsAge related macular degeneration
dc.keywordsDrusen
dc.keywordsDry AMD
dc.keywordsLow-level light therapy
dc.keywordsPhotobiomodulation
dc.language.isoeng
dc.publisherSpringer
dc.relation.ispartofOphthalmology and Therapy
dc.subjectOphthalmology
dc.titleSafety, tolerability, and short-term efficacy of low-level light therapy for dry age-related macular degeneration
dc.typeJournal Article
dspace.entity.typePublication
local.contributor.kuauthorHasanreisoğlu, Murat
local.contributor.kuauthorKesim, Cem
local.publication.orgunit1SCHOOL OF MEDICINE
local.publication.orgunit2School of Medicine
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