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Triple Therapy of Pars Plana Vitrectomy and Grid/Focal Laser for Diabetic Macular Edema (DME)

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ClinicalTrials.gov Identifier: NCT01202461
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : September 15, 2010
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:

This study is designed to report 3-year result of triple therapy of vitrectomy, intravitreal triamcinolone and macular laser photocoagulation for intractable diabetic macular edema.

Previously author reported 1-year result(Am J Ophthalmol. 2007 Dec;144(6):878-885. Epub 2007 Oct 15.).


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Edema Procedure: Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three-year Result of Triple Therapy of Vitrectomy, Intravitreal Triamcinolone and Macular Laser Photocoagulation for Intractable Diabetic Macular Edema
Study Start Date : August 2010
Primary Completion Date : August 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources


Intervention Details:
    Procedure: Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation

    all pars plana vitrectomy were accompanied with removal of retinal Internal limiting membrane (ILM) around fovea in round fashion with a dimension of approximately 2 disc diameters.

    IVTA was introduced at the end of surgery or on the next day (4mg in 0.1cc). Two weeks afterward, fluorescein angiography guided macular laser photocoagulation which consisted of direct photocoagulation on leaking microaneurysms and application of grid pattern laser was undertaken.



Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: At baseline, 6,12,24,36 months after surgery ]
    Measurement of visual acuity at every visit. VA at every visit was compared from VA at baseline


Secondary Outcome Measures :
  1. Central subfield macular thickness [ Time Frame: 0,6,12,24,36 months after surgery ]
    Automatically measured central subfield thickness from Stratus OCT



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of diabetes mellitus
  • intractable diffuse DME (diffuse DME which did not respond to or recurred after the previous IVTA and/or macular focal laser photocoagulation)
  • central subfield macular thickness (CST) greater than 250μm

Exclusion Criteria:

  • presence of vitreomacular traction
  • a prior history of treatment for the DME within 3 months or vitreoretinal surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202461


Locations
Korea, Republic of
Samsung Medical Center
Seoul, S. Korea, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01202461     History of Changes
Other Study ID Numbers: 2010-07-209
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Keywords provided by Samsung Medical Center:
Diabetic macular edema
Combination therapy for DME
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases