Micropulse Laser Photocoagulation in Diabetic Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: micropulse laser photocoagulation, micropulse laser photocoagulation.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Micropulse Laser Photocoagulation Treatment of Diabetic Macular Edema ; 5 % Versus 15 % Duty Cycle
Overview
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 .
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 .
Interventions
- 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
Primary outcome measures
- central macular thickness [Time frame: 3 months]
Eligibility criteria
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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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 .
- Bodea 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 37629677
- 1. 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.
Identifiers
NCT: NCT07266597 · Soh-Med-25-7-23MS