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Recruiting NCT07295704

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

— Observational Micropulse Laser Treatment Initial Refractory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Micropulse Laser.
Who it may be relevant to
Registry conditions: Micropulse Laser, Treatment, Initial, Refractory. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Diabetic Retinopathy (DR) is a common and specific microvascular complication of diabetes that affects 17-54% of people with diabetes aged between 49 and 60 years.

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.

Interventions

  • Other 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.

Primary outcome measures

  • Change of best-corrected visual acuity [Time frame: 6 months post-procedure]
Secondary outcome measures (3)
  • Change of central macular thickness [Time frame: 6 months post-procedure]
  • Change of area thickness [Time frame: 6 months post-procedure]
  • Change of macular volume [Time frame: 6 months post-procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • the General Authority for Teaching Hospitals and Institutes — Cairo

Identifiers

NCT: NCT07295704 · HSO00011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗