Diabetic Macular Edema
Conditions
Keywords
diabetic macular edema, micropulse, laser, subthreshold
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.
Interventions
DEVICE577-MPL
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
DEVICE532-SLP
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
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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%)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in 10°retinal sensitivity | 1 year | Retinal sensitivity will be measured by microperimetry |
| Change of fundus autofluorescence | 1 year | Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment |
| Change of Central Retinal Thickness(CRT) | 1 year | Central Retinal Thickness will be performed by optical coherence tomography(OCT) |
Countries
China
Outcome results
None listed