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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01202461
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 40.3

Study Details

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.).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Macular Edema	Procedure: Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Three-year Result of Triple Therapy of Vitrectomy, Intravitreal Triamcinolone and Macular Laser Photocoagulation for Intractable Diabetic Macular Edema
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Outcome Measures

Primary Outcome Measures

1. 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

1. Central subfield macular thickness [0,6,12,24,36 months after surgery]

   Automatically measured central subfield thickness from Stratus OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul	S. Korea	Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01202461
• Other Study ID Numbers: 2010-07-209
• First Posted: Sep 15, 2010
• Last Update Posted: Sep 15, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: Diabetic macular edema; Combination therapy for DME; DME
• Additional relevant MeSH terms: Macular Edema; Diabetic Retinopathy; Edema

Study Results

No Results Posted as of Sep 15, 2010