Unique ID issued by UMIN | UMIN000020216 |
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Receipt number | R000023348 |
Scientific Title | Quantitative analysis of vitreous and plasma concentrations of brilliant blue G after use as a surgical adjuvant in chromovitrectomy |
Date of disclosure of the study information | 2015/12/16 |
Last modified on | 2015/12/16 11:17:13 |
Quantitative analysis of vitreous and plasma concentrations of brilliant blue G after use as a surgical adjuvant in chromovitrectomy
Residualplasma concentrations of BBG after chromovitrectomy
Quantitative analysis of vitreous and plasma concentrations of brilliant blue G after use as a surgical adjuvant in chromovitrectomy
Residualplasma concentrations of BBG after chromovitrectomy
Japan |
Chromovitrevictomy for ERM and macular hole
Ophthalmology |
Others
NO
To analyse vitreous and plasma concentration of BBG after chromovitrectomy
PK,PD
Exploratory
Phase I,II
Plasma concentrations of BBG after chromovitrectomy
Vitreous concentrations of BBG after chromovitrectomy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Brilliant Blue G
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients required for vitrectomy in one or both eyes
Primary diseases for vitrectomy are macular hole, epiretinal macular membrane, macular hole retinal detachment cased by high myopia , proliferativevitreoretinopathy, preproliferative diabetic retinopathy, diabetic macular edema, macular edema cased by occlusion of retinal vein, and stainig and peeling of internal limiting membrane in vitrectomy are necessary.
2) Age : >=20 years old at the time of obtaining informed consent
3) Male or female passed 2 years after menopause
4) Patients comply with the schedule instructed by PI or SI
5) Patients take part in this trial based on their own free will and give informed consent in written form.
1) Vitrectomized eye.
2) Has serious of digestive, circulatory, kidney, liver, or blood/coagulation complications
3) Had present and past uveitis or glaucoma
4) Has a history of drug hypersensitivity reactions for Triamcinolone acetonide, mydriatic, antibacterial eyedrops or local anesthetic.
5) Has a history of drug or alcohol abuse
6) Had taken this clinical trial
7) Will take part in in another clinical trial or clinical research during this clinical trial
8) Is deemed unsuitable for this trial by PI or SI
5
1st name | |
Middle name | |
Last name | Hiroshi Enaida |
Kyusyu University Hospital, Ohshima Hospital of Ophthalmology
Ophthalmology
3-1-1, Maidashi, Higashi-ku, Fukuoka
81-92-642-5645
enaida@cc.saga-u.ac.jp
1st name | |
Middle name | |
Last name | Makiko Uchiyama |
Kyusyu University Hospital
Center for Clinical and Translational Research
3-1-1, Maidashi, Higashi-ku, Fukuoka
81-92-642-6291
m-uchi@med.kyushu-u.ac.jp
Kyusyu University Hospital, Ohshima Hospital of Ophthalmology
The Japan Medical Association Center for Clinical Trials
Japan
NO
大島眼科病院
2015 | Year | 12 | Month | 16 | Day |
Published
http://ovidsp.tx.ovid.com/sp-3.18.0b/ovidweb.cgi?QS2=434f4e1a73d37e8c504983e01e46c99aa269a6408c9ceb4
BBG, which remained at low levels in the vitreous cavity, was not found in the systemic blood flow after the operation. Thus, any adverse effects of systemic BBG would be avoided.
Completed
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 31 | Day |
2012 | Year | 05 | Month | 31 | Day |
2012 | Year | 06 | Month | 30 | Day |
2012 | Year | 08 | Month | 31 | Day |
2015 | Year | 12 | Month | 16 | Day |
2015 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023348
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