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This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema compared with 532 subthreshold laser photocoagulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 577-MPL | Experimental | 577nm micropulse laser photocoagulation(577MPL) treatment to the macular area of retinal thickening with a focal or grid pattern |
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| 532-SLP | Active Comparator | 532nm subthreshold laser photocoagulation(532-SLP) treatment to the macular area of retinal thickening with a focal or grid pattern |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 577-MPL | Device | Device for 577nm micropulse treatment of the diabetic macular edema with the following parameters:100 microns spot size,5% duty cycle of 0.2 seconds,power is tested on micropulse mode and then reduce power to 50% of visible |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Best Corrected Visual Acuity(BCVA) | Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 10°retinal sensitivity | Retinal sensitivity will be measured by microperimetry | 1 year |
| Change of fundus autofluorescence | Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chenjin Jin | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Director |
| Lijun Zhou | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21345996 | Background | Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828. |
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| 532-SLP | Device | Device for 532nm subthreshold treatment of the diabetic macular edema, by decomposing a subthreshold short pulse, with 10 milliseconds, 100 microns, and power(100-1000mW) adjusted according to patient's diopter transparency and pigmentation |
|
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| 1 year |
| Change of Central Retinal Thickness(CRT) | Central Retinal Thickness will be performed by optical coherence tomography(OCT) | 1 year |