Back to resultsTriple Therapy of Pars Plana Vitrectomy and Grid/Focal Laser for Diabetic Macular Edema (DME)
Primary Purpose
Diabetic Retinopathy, Macular Edema
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic macular edema, Combination therapy for DME, DME
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Outcomes
Primary Outcome Measures
Best-corrected visual acuity
Measurement of visual acuity at every visit. VA at every visit was compared from VA at baseline
Secondary Outcome Measures
Central subfield macular thickness
Automatically measured central subfield thickness from Stratus OCT
Full Information
NCT ID
NCT01202461
First Posted
September 14, 2010
Last Updated
September 14, 2010
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01202461
Brief Title
Triple Therapy of Pars Plana Vitrectomy and Grid/Focal Laser for Diabetic Macular Edema (DME)
Official Title
Three-year Result of Triple Therapy of Vitrectomy, Intravitreal Triamcinolone and Macular Laser Photocoagulation for Intractable Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Edema
Keywords
Diabetic macular edema, Combination therapy for DME, DME
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best-corrected visual acuity
Description
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
Secondary Outcome Measure Information:
Title
Central subfield macular thickness
Description
Automatically measured central subfield thickness from Stratus OCT
Time Frame
0,6,12,24,36 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
S. Korea
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Triple Therapy of Pars Plana Vitrectomy and Grid/Focal Laser for Diabetic Macular Edema (DME)
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