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

NCT07295704 | Recruiting

• 1 other identifier: HSO00011
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory; Treatment; Initial; Micropulse Laser; Center-Involved Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change of best-corrected visual acuity

  Change of best-corrected visual acuity will be recorded.

  6 months post-procedure

Secondary Outcomes (3)

• Change of central macular thickness

  6 months post-procedure

• Change of area thickness

  6 months post-procedure

• Change of macular volume

  6 months post-procedure

Study Arms (2)

Naïve center-involved diabetic macular edema group

Patients with treatment-naïve center-involved diabetic macular edema.

Other: Micropulse Laser

Refractory center-involved diabetic macular edema group

Patients with refractory center-involved diabetic macular edema.

Other: Micropulse Laser

Interventions

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.

Naïve center-involved diabetic macular edema group; Refractory center-involved diabetic macular edema group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The General Authority for Teaching Hospitals and Institutes: lead

Study Sites (1)

the General Authority for Teaching Hospitals and Institutes

Cairo, 11562, Egypt

RECRUITING

Central Study Contacts

Hossam A Hassan, MD

CONTACT

00201026808348; Dr.hossameabdalfataah@gothi.gov.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of Ophthalmology, Sohag Teaching Hospital, Egypt.

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 22, 2025
• Study Start: October 15, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)