The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on patients with dry Age Related Macular Degeneration (AMD). Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and energy directly on the eye to improve retinal function and delay AMD progression. This is a prospective 2 center phase 2 clinical pilot study with no placebo group.
Dry AMD is a progressive sight threatening disease affecting central acute vision. Dry AMD may progress to the wet form where leaking and bleeding in the retina can cause sudden severe visual loss. There are no proven active treatments for Dry AMD. Dry AMD accounts for over 80% of AMD cases. There are estimated to be 30 million people afflicted with AMD by the year 2020 in North America. Photobiomodulation in this study is utilised by using two devices that are already approved for other indications by the FDA and Health Canada. Photobiomodulation is a novel clinical application for treating dry AMD. As this is a pilot study there is no placebo or control group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Two separate light emitting devices that are already approved for other indications are used. Treatment will consist of 18 treatments lasting approximately two minutes per treatment.
Dr Robert Dotson
Oak Ridge, Tennessee, United States
Dr Graham Merry
Toronto, Ontario, Canada
Change in ETDRS Visual Acuity
Time frame: prior to intervention and 3 monthly intervals to 1 year
change in contrast sensitivity
Time frame: prior to intervention and 3 monthly to 1 year
changes in retinal function parameters from Nidek MP1 assessment
Time frame: prior to intervention and 3 monthly to 1 year
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