Micropulse Laser Photocoagulation in Diabetic Macular Edema

NCT ID: NCT07266597

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-02-01

Brief Summary

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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

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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 .

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

will be treated using 5 % duty cycle

Group Type ACTIVE_COMPARATOR

micropulse laser photocoagulation

Intervention Type PROCEDURE

micropulse laser photocoagulation in treatment of diabetic macular edema, 5% duty cycle

Group B

will be treated using 15 % duty cycle .

Group Type ACTIVE_COMPARATOR

micropulse laser photocoagulation

Intervention Type PROCEDURE

micropulse laser photocoagulation in treatment of diabetic macular edema,15% duty cycle

Interventions

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micropulse laser photocoagulation

micropulse laser photocoagulation in treatment of diabetic macular edema, 5% duty cycle

Intervention Type PROCEDURE

micropulse laser photocoagulation

micropulse laser photocoagulation in treatment of diabetic macular edema,15% duty cycle

Intervention Type PROCEDURE

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Younis Shabaan Aboelhassan

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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younis shabaan abu alhassan, resident

Role: CONTACT

01027389944

mortada ahmed abu zeid, professor

Role: CONTACT

01203324446

References

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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 .

Reference Type RESULT

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.

Reference Type RESULT
PMID: 37629677 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

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Soh-Med-25-7-23MS

Identifier Type: -

Identifier Source: org_study_id

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