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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University of Paris
RECRUITING
Paris
Italy
Università degli Studi di Ferrara
RECRUITING
Ferrara
Università degli studi della Campania Luigi Vanvitelli
RECRUITING
Napoli
Università di Torino
RECRUITING
Torino
Turkey
University of Ankara
RECRUITING
Ankara
Koç University Hospital
RECRUITING
Koç
United Kingdom
Earlam and Christopher
RECRUITING
Taunton
Contact Information
Primary
Giuseppe Giannaccare
giuseppe.giannaccare@unicz.it
003909613647135
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 180
Treatments
Experimental: Treatment group
Two cycles of treatment using continuous and pulsed yellow light followed by continuous and pulsed red light.~Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).
Sham_comparator: Sham group
Sham treatment will occur using a sham mask, designed to release a very low level of light, in this way the patient will not be able to distinguish if he is receiving the treatment or not.~Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).
Sponsors
Leads: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

This content was sourced from clinicaltrials.gov

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