RecruitingNCT07295704

Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema

Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema

Sponsor

The General Authority for Teaching Hospitals and Institutes

Enrollment

50 participants

Start Date

Oct 15, 2025

Study Type

OBSERVATIONAL

Conditions

Treatment Refractory Micropulse Laser Initial Center-Involved Diabetic Macular Edema

Summary

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

Min Age: 18 Years

Inclusion Criteria4

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).

Exclusion Criteria13

Monocular eyes.
Chronic renal failure or renal transplant because of diabetic nephropathy.
Glycated hemoglobin (HbA1c) of more than 10%.
Vitreomacular traction syndrome.
Epiretinal membrane.
PRP within 4months before the treatment.
Intraocular surgery within 6months, including cataract or vitreoretinal operation.
Rubeosis iridis.
Severe glaucoma.
High-risk proliferative diabetic retinopathy.
Poor dilation.
Increased foveal avascular zone.
Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.

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Interventions

OTHERMicropulse Laser

All 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.