Triple Therapy of Pars Plana Vitrectomy and Grid/Focal Laser for Diabetic Macular Edema (DME)
|ClinicalTrials.gov Identifier: NCT01202461|
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : September 15, 2010
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Central subfield macular thickness [ Time Frame: 0,6,12,24,36 months after surgery ]Automatically measured central subfield thickness from Stratus OCT
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202461
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, S. Korea, Korea, Republic of, 135-710|