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NCT Number: NCT01202461

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

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.).

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, S. Korea, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation

Procedure

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 outcomes

  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 outcomes

  1. Central subfield macular thickness

    Time frame: 0,6,12,24,36 months after surgery

    Automatically measured central subfield thickness from Stratus OCT

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Three-year Result of Triple Therapy of Vitrectomy, Intravitreal Triamcinolone and Macular Laser Photocoagulation for Intractable Diabetic Macular Edema

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2010
Registry last updated
Sep 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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