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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation (Gentlewaves, Warp 10) | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ETDRS Visual Acuity | prior to intervention and 3 monthly intervals to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| change in contrast sensitivity | prior to intervention and 3 monthly to 1 year | |
| changes in retinal function parameters from Nidek MP1 assessment | prior to intervention and 3 monthly to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham F Merry, MBBS; LMCC | Dr. Graham Merry | Principal Investigator |
| Robert Dotson, M.D. | Dr. Robert Dotson | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Robert Dotson | Oak Ridge | Tennessee | 37830 | United States | ||
| Dr Graham Merry |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 22, 2012 | |
| Reset | Nov 20, 2012 | |
| Release | Apr 22, 2013 | |
| Reset | May 23, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 22, 2012 | Nov 20, 2012 | |||
| Apr 22, 2013 |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| Toronto |
| Ontario |
| M5R 1C4 |
| Canada |
| May 23, 2013 |