Micropulse Laser Photocoagulation in Diabetic Macular Edema

Sohag University

Status: Not yet enrolling

Conditions: Diabetic Macular Edema

Treatments: Procedure: micropulse laser photocoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07266597

Soh-Med-25-7-23MS

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

group A

Active Comparator group

Description:

will be treated using 5 % duty cycle

Treatment:

Procedure: micropulse laser photocoagulation

Procedure: micropulse laser photocoagulation

Group B

Active Comparator group

Description:

will be treated using 15 % duty cycle .

Treatment:

Procedure: micropulse laser photocoagulation

Procedure: micropulse laser photocoagulation