577nm Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Registration Number
- NCT02406157
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- Aged >18 years
- Patients with diabetes mellitus type 2
- Diagnosed as diabetic retinopathy with Clinical Significant Macular Edema
- Central retinal thickness(CRT) of more than 250μm as measured by optical coherence tomography (OCT)
- ETDRS visual acuity >19 letters (Snellen equivalent of 20/400 or better)
- No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
- Blood glucose was controlled steadily(HbA1c≤10%)
- Taking part in other clinical trial within 3 months
- Planning panretinal photocoagulation(PRP) within 3 months
- Performed cataract surgery in the last 3 months
- Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
- Accompanied with severe opacity of refractive media that maybe impact therapy and observation
- Accompanied with nystagmus
- Accompanied with some history that maybe interfere with result or increase the risk of patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of Best Corrected Visual Acuity(BCVA) 1 year Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
- Secondary Outcome Measures
Name Time Method Change of fundus autofluorescence 1 year Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment
Change in 10°retinal sensitivity 1 year Retinal sensitivity will be measured by microperimetry
Change of Central Retinal Thickness(CRT) 1 year Central Retinal Thickness will be performed by optical coherence tomography(OCT)
Trial Locations
- Locations (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Zhongshan Ophthalmic Center, Sun Yat-sen University🇨🇳Guangzhou, Guangdong, China