Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration (TORPA)
|ClinicalTrials.gov Identifier: NCT00940407|
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : November 18, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonexudative Age-related Macular Degeneration||Device: Photobiomodulation (Gentlewaves, Warp 10)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
- Device: Photobiomodulation (Gentlewaves, Warp 10)
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.Other Names:
- Warp 10
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|