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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01202461
First received: September 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Best-corrected visual acuity [ Time Frame: At baseline, 6,12,24,36 months after surgery ] [ Designated as safety issue: No ]
    Measurement of visual acuity at every visit. VA at every visit was compared from VA at baseline


Secondary Outcome Measures:
  • Central subfield macular thickness [ Time Frame: 0,6,12,24,36 months after surgery ] [ Designated as safety issue: No ]
    Automatically measured central subfield thickness from Stratus OCT


Estimated Enrollment: 41
Study Start Date: August 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202461

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

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01202461     History of Changes
Other Study ID Numbers: 2010-07-209
Study First Received: September 14, 2010
Last Updated: September 14, 2010
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 22, 2014