Micropulse Laser Photocoagulation in Diabetic Macular Edema

November 24, 2025 updated by: Younis Shabaan Aboelhassan, Sohag University

Micropulse Laser Photocoagulation Treatment of Diabetic Macular Edema ; 5 % Versus 15 % Duty Cycle

To assess the safety and efficacy of 532 nm subthreshold micropulse laser 5 % duty cycle compared with 15 % duty cycle in treatment of diabetic macular edema .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

prospective interventional randomized comparative study that will be conducted on Patients with diabetic retinopathy who Are More than 18 years old with diabetic macular edema with a central retinal thickness < 400 um and best corrected visual acuity between 6/18 and 6/60 .

The participants will be divided randomly into two groups All Patients will receive single session of 532 nm subthreshold micropulse laser ,the following parameters will be used in all cases as follows,spot size : 200-µm ,exposure duration:200-ms ,power : 500-mW

While duty cycle will differ between 2 groups as follows :- Group A : will be treated using 5 % duty cycle . Group B : will be treated using 15 % duty cycle . follow up visits as follows 1 week ,4 weeks 12 weeks after laser therapy .

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: mortada ahmed abu zeid, professor
  • Phone Number: 01203324446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients with diabetic retinopathy who:

  • Are More than 18 years old .
  • have diabetic macular edema with a central retinal thickness < 400 um .
  • have best corrected visual acuity between 6/18 and 6/60 .

Exclusion Criteria:

  • Previous lasered retina , Anti - VEGF injection or vitrectomy .
  • Extensive Macular ischemia on FFA .
  • Media opacity .
  • Associated ocular pathology as glaucoma, CNV (choroidal neovascularization ) , AMD (age related macular degenerations ), epiretinal membrane vitreomacular traction and retinal vein occlusion .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
will be treated using 5 % duty cycle
Procedure: micropulse laser photocoagulation
micropulse laser photocoagulation in treatment of diabetic macular edema, 5% duty cycle
Procedure: micropulse laser photocoagulation
micropulse laser photocoagulation in treatment of diabetic macular edema,15% duty cycle
Active Comparator: Group B
will be treated using 15 % duty cycle .
Procedure: micropulse laser photocoagulation
micropulse laser photocoagulation in treatment of diabetic macular edema, 5% duty cycle
Procedure: micropulse laser photocoagulation
micropulse laser photocoagulation in treatment of diabetic macular edema,15% duty cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central macular thickness
Time Frame: 3 months
assessment of change of central macular thickness before and after laser treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med-25-7-23MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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