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

Samsung Medical Center

Status and phase: Completed; Phase 1

Conditions: Macular Edema; Diabetic Retinopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01202461

2010-07-209

Details and patient eligibility

About

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.).

Enrollment: 41 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)