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Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema

Not Applicable
Conditions
Diffuse Diabetic Macular Edema.
Disorders of choroid and retina
H30-H36
Registration Number
IRCT201205029617N1
Lead Sponsor
Vice-Chancellor in Research Affairs Ahvaz Jundishapur University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
105
Inclusion Criteria

patients of either gender aged more than18 years; diabetes mellitus (type 1 or 2); best corrected visual acuity (BCVA) in the study eye between 35 and 69 ETDRS letters at 4 m (Snellen equivalent 1/10-5/10); central foveal thickness more than 270 micrometer; media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus imaging; intraocular pressure (IOP )less than 21 mmHg; ability to return for regular study visits; fellow eye has vissual acuity more than 20/400; fellow eye has received no antivascular endothelial growth factor (VEGF) treatment within the past 3 months and diffuse diabetic macular edema based on fluorescein angiography.
Exclusion criteria(ocular criteria were applied to the
study eye only): macular ischemia (foveal avascular
zone [FAZ] more than1000 micrometer
or severe perifoveal intercapillary loss on fluorescein angiography); macular edema due to a cause other than diabetic maculopathy; coexistent ocular disease: a preexisting ocular condition that was likely to preclude vissual acuity improvement despite resolution of macular edema ( foveal atrophy, amblyopia, retinal vascular occlusion, neovascular glaucoma, ...); proliferative diabetic retinopathy
more than one disc in area in peripheral retina with or without vitreous hemorrhage and history of intraoccular surgery like as cataract sugery or vitrectomy.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Central Macular Thickness. Timepoint: Before and Three months after Treatment. Method of measurement: Central Macular Thickness Evaluate with OCT Instrument.;Visual Acuity. Timepoint: Before Treatment and Three Months after Treatment. Method of measurement: Visual Acuity check with snellen chart.
Secondary Outcome Measures
NameTimeMethod
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