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Clinical Trials in Egypt / NCT07295704
Recruiting Observational

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

NCT07295704 · tracked via the Priya Life Science Egypt tracker
Sponsor
The General Authority for Teaching Hospitals and Institutes
Phase
Observational
Started
2025-10-15
Last updated
2025-12-22

Condition(s) studied

Micropulse LaserTreatmentInitialRefractoryCenter-Involved Diabetic Macular Edema

Investigational drug(s) / intervention(s)

Micropulse Laser

Micropulse 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Change of best-corrected visual acuity — 6 months post-procedure
    Change of best-corrected visual acuity will be recorded.

Trial sites (1)

FacilityCityRegionStatus
the General Authority for Teaching Hospitals and Institutes Cairo Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07295704 on ClinicalTrials.gov ↗ ← All trials in Egypt