NCT07266597

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Nov 2025Feb 2027

First Submitted

Initial submission to the registry

November 24, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

micropulse , diabetic macular edema

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 COMPARATOR

will be treated using 5 % duty cycle

Procedure: micropulse laser photocoagulation

Group B

ACTIVE COMPARATOR

will be treated using 15 % duty cycle .

Procedure: micropulse laser photocoagulation

Interventions

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

group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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 .

    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.

  • 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.

    RESULT

Central Study Contacts

younis shabaan abu alhassan, resident

CONTACT

mortada ahmed abu zeid, professor

CONTACT

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