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

Phase 1

Completed

• Conditions: Diabetic Retinopathy; Macular Edema

• Registration Number: NCT01202461
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-08
• Status Verified: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Last Update Submitted: 2010-09-14
• Study First Posted: 2010-09-15
• Last Update Posted: 2010-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity	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 Outcome Measures

Name	Time	Method
Central subfield macular thickness	0,6,12,24,36 months after surgery	Automatically measured central subfield thickness from Stratus OCT

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, S. Korea, Korea, Republic of