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Sequentially Combined Vitrectomy, IVTA and Macular Focal Laser Photocoagulation for Diabetic Macular Edema

NCT ID: NCT00371410

Last Updated: 2006-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-10-31

Brief Summary

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Macular edema constitutes the primary cause of visual impairment in diabetic patients with a disease duration of 20 years or more. Intravitreal triamcinolone (IVTA) and macular focal laser photocoagulation were reported to generate favorable results in the treatment of diabetic macular edema, but there have been patients with diffuse diabetic macular edema refractory to such treatment modalities. The present study will test the safety and the efficacy of the combined treatment of vitrectomy, IVTA and macular focal laser photocoagulation in the treatment of intractable diffuse diabetic macular edema.

Detailed Description

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Fifty eyes from 50 diabetic patients were included, who had been diagnosed with intractable diffuse diabetic macular edema (DME). Intractable diffuse DME was defined as a biomicroscopically, angiographically and tomographically proven diffuse DME, which did not respond to or recurred after the previous intravitreal triamcinolone acetonide (IVTA) and/or macular focal laser photocoagulation. The central macular thickness (CMT) had to be greater than 250 μm. Preoperative ocular examination included best corrected visual acuity (BCVA) using the ETDRS chart, applanation tonometry, slit-lamp biomicroscopy, dilated fundus examination, optical coherence tomography (OCT) and fluorescein angiography. Pars plana vitrectomy with removal of retinal internal limiting membrane (ILM) was performed in all the 50 subject eyes. On the day after vitrectomy, triamcinolone acetonide (0.1 mL, 40 mg/mL) was injected intravitreally. Macular focal laser photocoagulation was performed 2 weeks after vitrectomy. As main outcome measures, BCVA was recorded and the CMT was measured using OCT by independent observers for all subjects at 3 and 6 months after the laser photocoagulation.

Conditions

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Diabetic Macular Edema

Keywords

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Vitrectomy Intravitreal triamcinolone acetonide Macular focal laser photocoagulation Best-corrected visual acuity Central macular thickness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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vitrectomy

Intervention Type PROCEDURE

intravitreal triamcinolone acetonide

Intervention Type DRUG

macular focal laser photocoagulation

Intervention Type PROCEDURE

Eligibility Criteria

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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)
* the central macular thickness (CMT) greater than 250 μm

Exclusion Criteria

* presence of vitreomacular traction
* a prior history of treatment for the DME within 3 months or vitreoretinal surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Se Woong Kang, MD

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kang SW, Park SC, Cho HY, Kang JH. Triple therapy of vitrectomy, intravitreal triamcinolone, and macular laser photocoagulation for intractable diabetic macular edema. Am J Ophthalmol. 2007 Dec;144(6):878-885. doi: 10.1016/j.ajo.2007.07.044. Epub 2007 Oct 15.

Reference Type DERIVED
PMID: 17936715 (View on PubMed)

Other Identifiers

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2006-05-029

Identifier Type: -

Identifier Source: org_study_id