Age-Related Macular Degeneration
Conditions
Keywords
Age related Macular Degeneration, Photobiomodulation
Brief 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.
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)
Sponsors
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Concomitant epilepsy * Neurological diseases * Psychiatric pathologies * Herpes virus infections * Dense cataract * Pregnancy * Other significant ocular and/or retinal diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity variation | 1 month, 2 months and 4 months after each cycle | ETDRS letters |
| Drusen Volume Variation | 1 month, 2 months and 4 months after each cycle | Based on SD-OCT Heidelberg |
| Contrast sensitivity variation | 1 month, 2 months and 4 months after each cycle | Based on Pelli Robson chart |
Countries
France, Italy, Turkey (Türkiye), United Kingdom
Contacts
Primary ContactGiuseppe Giannaccare
Outcome results
None listed