RecruitingNot Applicable

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

Egypt50 participantsStarted 2025-10-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of best-corrected visual acuity

Timeframe: 6 months post-procedure

Trial details

NCT IDNCT07295704

SponsorThe General Authority for Teaching Hospitals and Institutes

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-03-30

Contact for this trial

Hossam A Hassan, MD

00201026808348 Dr.hossameabdalfataah@gothi.gov.eg

View on ClinicalTrials.gov More Micropulse Laser trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.