A Phase 1 interventional study of Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation in Diabetic Retinopathy and Macular Edema, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-09-15.
Sponsored by Samsung Medical Center · Phase 1, Interventional, and Treatment
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.).
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's planned enrollment of 41 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Measurement of visual acuity at every visit. VA at every visit was compared from VA at baseline
Time frame: At baseline, 6,12,24,36 months after surgery
Central subfield macular thickness
Automatically measured central subfield thickness from Stratus OCT
Time frame: 0,6,12,24,36 months after surgery
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center