Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration (TORPA)
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.
|Nonexudative Age-related Macular Degeneration||Device: Photobiomodulation (Gentlewaves, Warp 10)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.|
- 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 ]
|Study Start Date:||January 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Device: Photobiomodulation (Gentlewaves, Warp 10)
- Warp 10
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940407
|United States, Tennessee|
|Dr Robert Dotson|
|Oak Ridge, Tennessee, United States, 37830|
|Dr Graham Merry|
|Toronto, Ontario, Canada, M5R 1C4|
|Principal Investigator:||Graham F Merry, MBBS; LMCC||Dr. Graham Merry|
|Principal Investigator:||Robert Dotson, M.D.||Dr. Robert Dotson|