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

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

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.


Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01202461

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 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

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Edema
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Vascular Diseases processed this record on February 10, 2016