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Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

NCT04359771 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-06-01

Study results available
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Summary

Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.

Conditions

Interventions

DEVICE

Yellow micro-pulse laser

applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea

DEVICE

Diode micro-pulse laser

applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Hany S Hamza, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2018-09-25
Completion
2018-09-25
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359771 on ClinicalTrials.gov