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HIPAA Compliant
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Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID06046118

Evaluating Yellow and Red LED Photobiomodulation for Treating Dry Age-Related Macular Degeneration

Led by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro · Updated on 2024-09-19

180

Participants Needed

7

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in people with dry age-related macular degeneration AMD. The study aims to determine whether this light therapy can reduce drusen volume and improve visual acuity and contrast sensitivity in affected patients. Participants will be randomly assigned to either the treatment group or a sham placebo group to compare outcomes. The treatment involves two cycles, each with two phases. The first phase includes 300 seconds of continuous Yellow light with eyes closed followed by 60 seconds of pulsed Yellow light with eyes open. The second phase consists of 300 seconds of continuous Red light with eyes closed and 60 seconds of pulsed Red light with eyes open. Cycle 1 has 8 sessions over 4 weeks two sessions per week, and Cycle 2 has 6 sessions over 3 weeks two sessions per week. The sham group will receive a low-level light mask that looks similar but does not provide the active treatment. Participants will undergo assessments at 1 month, 2 months, and 4 months after each treatment cycle. These include measuring best corrected visual acuity, drusen volume, and contrast sensitivity. The study uses a double-masked randomized design to compare changes between the treatment and sham groups. The total participation time includes these treatment cycles and follow-up visits to evaluate the effects of the photobiomodulation therapy.

CONDITIONS

Brief Title

Photobiomodulation in Dry Age Related Macular Degeneration

Research Team

G

Giuseppe Giannaccare

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