Micropulse Laser Photocoagulation in Diabetic Macular Edema
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedStudy Start
First participant enrolled
November 30, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
December 5, 2025
November 1, 2025
1 year
November 24, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
central macular thickness
assessment of change of central macular thickness before and after laser treatment
3 months
Study Arms (2)
group A
ACTIVE COMPARATORwill be treated using 5 % duty cycle
Group B
ACTIVE COMPARATORwill be treated using 15 % duty cycle .
Interventions
micropulse laser photocoagulation in treatment of diabetic macular edema, 5% duty cycle
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Related Publications (3)
Ong J, Selvam A, Maltsev DS. Subthreshold laser systems: a narrative review of the current status and advancements for retinal diseases. Ann Eye Sci. 2022;7:15 .
RESULTBodea F, Bungau SG, Bogdan MA, Vesa CM, Radu A, Tarce AG, Purza AL, Tit DM, Bustea C, Radu AF. Micropulse Laser Therapy as an Integral Part of Eye Disease Management. Medicina (Kaunas). 2023 Jul 28;59(8):1388. doi: 10.3390/medicina59081388.
PMID: 37629677RESULT1. Bakri SJ, Wolfe JD, Regillo CD, Flynn HW, Wykoff CC. Evidence-Based Guidelines for Management of Diabetic Macular Edema. Journal of VitreoRetinal Diseases. 2019;3(3):145-152.
RESULT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
November 24, 2025
First Posted
December 5, 2025
Study Start
November 30, 2025
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
December 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share