About this trial
This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Both sexes.
Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20/400 or better, and center-involved DME [defined as a central macular thickness (CMT) of >250 but <700µm measured by spectral-domain optical coherence tomography].
Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).
Disqualifiers
Monocular eyes.
Chronic renal failure or renal transplant because of diabetic nephropathy.
Glycated hemoglobin (HbA1c) of more than 10%.
Vitreomacular traction syndrome.
Trial population
This prospective cohort comparative study was conducted at the Ophthalmology Department of Sohag Teaching Hospital, with approval from the institutional ethical committee.
Trial design
Cohort
Prospective
Treatments tested in this trial
Micropulse Laser
Other interventionAll laser procedures will be performed in a darkened room. The laser will be delivered together in an 8×8 pattern mode with high density (0µm of spacing) over the entire area of macular edema, including the foveal center and unthickened (200µm) retina with no attempt to target or avoid microaneurysms.
Treatment groups
Trial outcomes
Primary outcomes
Change of best-corrected visual acuity
Change of best-corrected visual acuity will be recorded.
Secondary outcomes
Change of central macular thickness
Change of central macular thickness will be recorded.
Change of area thickness
Change of area thickness will be recorded.
Change of macular volume
Change of macular volume will be recorded.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.