A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.
Diabetic macular edema (DME) is important vision threatening complication of diabetes mellitus. Laser photocoagulation, vitrectomy, intravitreal steroid injection and intravitreal antiVEGF (anti vascular endothelial growth factor) injection are being used as treatment of DME. Sustained releasing intravitreal dexamethasone implant has been known to be effective in reducing the central retinal thickness and gain of vision for DME. Although hard exudate at macula is important pathology of DME, impact of intravitreal dexamethasone implant on hard exudate are not studied yet. Therefore the investigators designed the descriptive study to reveal the hard exudate change in DME eyes treated with intravitreal dexamethasone implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
RECRUITINGKosin University Gospel Hospital
Busan, South Korea
RECRUITINGDong-A University hospital
Busan, South Korea
The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)
Time frame: after 12 months
The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity
Time frame: after 12 months
The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)
Time frame: after 12 months
The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography
Time frame: after 12 months
The average change in number of microaneurysm in macula
Time frame: after 12 months
The progression rate of cataract
Time frame: for 12 months
Number of eyes having increased intraocular pressure
Time frame: for 12 months
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Pusan national university hospital
Busan, South Korea
RECRUITINGInje University Haeundae Paik hospital
Busan, South Korea
RECRUITINGInje University Busan Paik hospital
Busan, South Korea
RECRUITINGKyungpook National University Hospital
Daegu, South Korea
RECRUITINGYeungnam University Medical Center
Daegu, South Korea
RECRUITING