Micropulse Laser Photocoagulation Treatment of Diabetic Macular Edema ; 5 % Versus 15 % Duty Cycle
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sohag University
- Enrollment
- 50
- Primary Endpoint
- central macular thickness
Overview
Brief Summary
To assess the safety and efficacy of 532 nm subthreshold micropulse laser 5 % duty cycle compared with 15 % duty cycle in treatment of diabetic macular edema .
Detailed Description
prospective interventional randomized comparative study that will be conducted on Patients with diabetic retinopathy who Are More than 18 years old with diabetic macular edema with a central retinal thickness < 400 um and best corrected visual acuity between 6/18 and 6/60 .
The participants will be divided randomly into two groups All Patients will receive single session of 532 nm subthreshold micropulse laser ,the following parameters will be used in all cases as follows,spot size : 200-µm ,exposure duration:200-ms ,power : 500-mW
While duty cycle will differ between 2 groups as follows :- Group A : will be treated using 5 % duty cycle . Group B : will be treated using 15 % duty cycle . follow up visits as follows 1 week ,4 weeks 12 weeks after laser therapy .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with diabetic retinopathy who:
- •Are More than 18 years old .
- •have diabetic macular edema with a central retinal thickness \< 400 um .
- •have best corrected visual acuity between 6/18 and 6/60 .
Exclusion Criteria
- •Previous lasered retina , Anti - VEGF injection or vitrectomy .
- •Extensive Macular ischemia on FFA .
- •Media opacity .
- •Associated ocular pathology as glaucoma, CNV (choroidal neovascularization ) , AMD (age related macular degenerations ), epiretinal membrane vitreomacular traction and retinal vein occlusion .
Outcomes
Primary Outcomes
central macular thickness
Time Frame: 3 months
assessment of change of central macular thickness before and after laser treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Younis Shabaan Aboelhassan
principle investigator
Sohag University