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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202461
• Other study ID #: 2010-07-209
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2010
• Last updated: September 14, 2010
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	S. Korea

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity	Measurement of visual acuity at every visit. VA at every visit was compared from VA at baseline	At baseline, 6,12,24,36 months after surgery	No
Secondary	Central subfield macular thickness	Automatically measured central subfield thickness from Stratus OCT	0,6,12,24,36 months after surgery	No