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NCT Number: NCT07295704

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the General Authority for Teaching Hospitals and Institutes

Cairo, 11562, Egypt

Location status: Recruiting

Location contact

Hossam A Hassan, MD

CONTACT

[email protected]

00201026808348

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micropulse Laser

Other

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 outcomes

  1. Change of best-corrected visual acuity

    Time frame: 6 months post-procedure

    Change of best-corrected visual acuity will be recorded.

Secondary outcomes

  1. Change of central macular thickness

    Time frame: 6 months post-procedure

    Change of central macular thickness will be recorded.

  2. Change of area thickness

    Time frame: 6 months post-procedure

    Change of area thickness will be recorded.

  3. Change of macular volume

    Time frame: 6 months post-procedure

    Change of macular volume will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Hossam A Hassan, MD

CONTACT

[email protected]

00201026808348

Sponsors and collaborators

Lead sponsor

The General Authority for Teaching Hospitals and Institutes

Network

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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