Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Retinopathy Macular Edema

Keywords

Diabetic macular edemaCombination therapy for DMEDME

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Central subfield macular thickness
0,6,12,24,36 months after surgery

Interventions

Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulationProcedure

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.

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Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

Sponsors & Collaborators

Samsung Medical Center
Otherlead

Study Sites (1)

Samsung Medical Center

Seoul, S. Korea, 135-710, South Korea

MeSH Terms

Conditions

Diabetic RetinopathyMacular Edema

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesMacular DegenerationRetinal Degeneration

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 15, 2010

Study Start

August 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2010

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations