RecruitingNot ApplicableNCT06046118

Photobiomodulation in Dry Age Related Macular Degeneration

Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study


Sponsor

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Enrollment

180 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are: * Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD? * Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group. Treatment consists in two cycles with two phases each: * 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened; * 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened. Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks). Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.


Eligibility

Min Age: 50 Years

Inclusion Criteria3

  • BCVA ETDRS > 40 L ETDRS at 4 meters
  • Diagnosis of DRY AMD AREDS grade 2-3
  • Ability to communicate well with the investigator and able to understand and comply with the requirements of the study

Exclusion Criteria7

  • Concomitant epilepsy
  • Neurological diseases
  • Psychiatric pathologies
  • Herpes virus infections
  • Dense cataract
  • Pregnancy
  • Other significant ocular and/or retinal diseases

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Interventions

DEVICEYellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)

Each session consists of: * 1st phase: 300 seconds of continuous Yellow light (eyes closed) + 60 seconds of pulsed Yellow light (eyes opened) * 2nd phase: 300 seconds of continuous Red light(eyes closed) + 60 seconds of pulsed Red light (eyes opened). Cycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks).

DEVICESham Mask

Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)


Locations(7)

University of Paris

Paris, France

Università degli Studi di Ferrara

Ferrara, Italy

Università degli studi della Campania Luigi Vanvitelli

Naples, Italy

Università di Torino

Torino, Italy

University of Ankara

Ankara, Turkey (Türkiye)

Koç University Hospital

Koç, Turkey (Türkiye)

Earlam and Christopher

Taunton, United Kingdom

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NCT06046118


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