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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01202461

Enrollment

Registered

2010-09-15

Start date

2010-08-31

Completion date

2010-09-30

Last updated

2010-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Macular Edema

Keywords

Diabetic macular edema, Combination therapy for DME, DME

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.).

Interventions

PROCEDURETriple 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026