Unique ID issued by UMIN | UMIN000008957 |
---|---|
Receipt number | R000010506 |
Scientific Title | A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema. |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2015/12/01 17:45:10 |
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
Japan |
diffuse diabetic macular edema
Ophthalmology |
Others
NO
To compare the effectiveness at improving visual acuity and decreasing central macular thickness in early vitrectomy for diffuse diabetic macular edema with intravitreal injection of triamcinolone acetonide.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
visual acuity
central macular thickness
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Numbered container method
2
Treatment
Medicine | Maneuver |
Pars plana vitrectomy and follow up for 24 months.
Intravitreal injection of triamcinolone acetonide and follow up for 24 months.
18 | years-old | <= |
Not applicable |
Male and Female
Aged 18 years or older.
Diffuse DME(CMT 300microns < determined by OCT).
BCVA between 58 and 74 letters of a ETDRS visual acuity scale.
Eyes of signs of vitreomacular traction on biomicroscopy or OCT.
Eyes with active proliferative DR.
Eyes with known a history of glaucoma,optic nerve atrophy,vitrectomy,intravitreal injection,subtenon injection.
Eyes with known a history of photocoagulation within 3 months,cataract operation within 6 months.
Patients with any of serious heart disease, cerebrovascular disease,blood disorder, renal failure, malignant tumor, systemic steroids.
Patients with HbA1c 10% or higher, or systolic blood pressure of more than 180 mmHg or diastolic blood pressure more than 110 mmHg.
Patients with known as steroid responder.
162
1st name | |
Middle name | |
Last name | Taiji Sakamoto |
Kagoshima University Graduate School of Medical and Dental Science
Department of Ophthalmology
Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
1st name | |
Middle name | |
Last name | Taiji Sakamoto |
Kagoshima University Graduate School of Medical and Dental Science
Department of Ophthalmology
Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Kagoshima University Graduate School of Medical and Dental Science
none
Self funding
Japan
NO
2012 | Year | 10 | Month | 01 | Day |
Unpublished
Terminated
2012 | Year | 09 | Month | 21 | Day |
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 09 | Month | 21 | Day |
2015 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010506