Actively Recruiting
Photobiomodulation in Dry Age Related Macular Degeneration
Led by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro · Updated on 2024-09-19
180
Participants Needed
7
Research Sites
91 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Photobiomodulation in Dry Age Related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Best corrected visual acuity (BCVA) on ETDRS chart greater than 40 letters at 4 meters
- Diagnosis of dry age-related macular degeneration (AMD) with AREDS grade 2 or 3
- Ability to communicate well with the investigator and understand and follow study requirements
You will not qualify if you...
- History of epilepsy
- Presence of neurological diseases
- Presence of psychiatric pathologies
- Herpes virus infections
- Dense cataract
- Pregnancy
- Other significant ocular and/or retinal diseases
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of Paris
Paris, France
Actively Recruiting
2
Università degli Studi di Ferrara
Ferrara, Italy
Actively Recruiting
3
Università degli studi della Campania Luigi Vanvitelli
Naples, Italy
Actively Recruiting
4
Università di Torino
Torino, Italy
Actively Recruiting
5
University of Ankara
Ankara, Turkey (Türkiye)
Actively Recruiting
6
Koç University Hospital
Koç, Turkey (Türkiye)
Actively Recruiting
7
Earlam and Christopher
Taunton, United Kingdom
Actively Recruiting
Research Team
G
Giuseppe Giannaccare
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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