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

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.

Study Overview

• Status: Recruiting
• Conditions: Treatment; Refractory; Micropulse Laser; Initial; Center-Involved Diabetic Macular Edema
• Intervention / Treatment: Other: Micropulse Laser

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Hossam A Hassan, MD; Phone Number: 00201026808348; Email: Dr.hossameabdalfataah@gothi.gov.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • The General Authority for Teaching Hospitals and Institutes
    • Contact: Hossam A Hassan, MD; Phone Number: 00201026808348; Email: Dr.hossameabdalfataah@gothi.gov.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This prospective cohort comparative study was conducted at the Ophthalmology Department of Sohag Teaching Hospital, with approval from the institutional ethical committee.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Naïve center-involved diabetic macular edema group; Patients with treatment-naïve center-involved diabetic macular edema.	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.
Refractory center-involved diabetic macular edema group; Patients with refractory center-involved diabetic macular edema.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of best-corrected visual acuity	Change of best-corrected visual acuity will be recorded.	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of central macular thickness	Change of central macular thickness will be recorded.	6 months post-procedure
Change of area thickness	Change of area thickness will be recorded.	6 months post-procedure
Change of macular volume	Change of macular volume will be recorded.	6 months post-procedure

Collaborators and Investigators

• Sponsor: The General Authority for Teaching Hospitals and Institutes

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HSO00011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No