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.
1. To evaluate the efficacy of 577nm micropulse laser photocoagulation with grid/focal treatment for diabetic macular edema. 2. To investigate influence of 577nm micropulse laser photocoagulation on structure and function of macula compared with 532nm subthreshold laser photocoagulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
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
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
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Change of Best Corrected Visual Acuity(BCVA)
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Time frame: 1 year
Change in 10°retinal sensitivity
Retinal sensitivity will be measured by microperimetry
Time frame: 1 year
Change of fundus autofluorescence
Fundus autofluorescence will be evaluated for different patterns(normal, increased, and decreased)before and after treatment
Time frame: 1 year
Change of Central Retinal Thickness(CRT)
Central Retinal Thickness will be performed by optical coherence tomography(OCT)
Time frame: 1 year
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