Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
NCT ID: NCT07295704
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-10-15
2026-03-30
Brief Summary
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Detailed Description
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Diabetic macular edema (DME) is one of the most common causes of visual loss in today's society. It affects about 10% of diabetic individuals and 29% of those who have had the condition for more than 20 years.
In micropulse mode, the laser emits short pulses, thereby reducing thermal energy in the target area.
This strategy has two properties: a shorter exposure time and a subvisible clinical endpoint, delivering energy by dividing the beam into a series of short pulses (100-300 µs). Every single pulse has an "on and off" duration (duty cycle (DC)), enabling tissues to cool down before the next pulse.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Naïve center-involved diabetic macular edema group
Patients with treatment-naïve center-involved diabetic macular edema.
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.
Refractory center-involved diabetic macular edema group
Patients with refractory center-involved diabetic macular edema.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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The General Authority for Teaching Hospitals and Institutes
NETWORK
Responsible Party
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Hossam Abdelfattah Husein Hassan
Fellow of Ophthalmology, Sohag Teaching Hospital, Egypt.
Locations
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the General Authority for Teaching Hospitals and Institutes
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Hossam A Hassan, MD
Role: primary
Other Identifiers
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HSO00011
Identifier Type: -
Identifier Source: org_study_id