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| Name | Class |
|---|---|
| Topcon Corporation | INDUSTRY |
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This trial seeks to prove that sub-lethal laser power levels are as effective and less damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of diabetic patients with a disease duration of 20 or more years and is one of the most frequent causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of clinically significant macular edema, reducing the incidence of vision loss by approximately 50% at 3 years' follow-up.
Sub-visible, non-damaging visible laser (532 nm) exposures of 100 ms in duration resulted in enhanced expression of heat shock proteins in the retina. To test clinical efficacy of sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to establish proper titration methods necessary to assure on one hand the lack of tissue damage, and on the other hand sufficient hyperthermia to elicit cellular response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topcon Endpoint Management Laser | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topcon Endpoint Management laser | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Visual acuity | Improvement in visual acuity > 10 letters or two lines in the ETDRS chart | 12 months |
| Reduction of the central macular thickness by SD-OCT | Reduction of the central macular thickness by SD-OCT | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cessation of leakage areas on FA | Use of fluorescein angiography to assess leakage and identify laser burn | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pravin U Dugel, MD | Retinal Consultants of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States |
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