Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Enrollment
- 180
- Locations
- 7
- Primary Endpoint
- Drusen Volume Variation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Giuseppe Giannaccare
Professor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Eligibility Criteria
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
Outcomes
Primary Outcomes
Drusen Volume Variation
Time Frame: 1 month, 2 months and 4 months after each cycle
Based on SD-OCT Heidelberg
Best Corrected Visual Acuity variation
Time Frame: 1 month, 2 months and 4 months after each cycle
ETDRS letters
Contrast sensitivity variation
Time Frame: 1 month, 2 months and 4 months after each cycle
Based on Pelli Robson chart