Unique ID issued by UMIN | UMIN000015355 |
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Receipt number | R000017860 |
Scientific Title | Anterior lens capsule staining by VisionBlue(R) in cataract surgery |
Date of disclosure of the study information | 2014/10/06 |
Last modified on | 2015/10/09 18:22:30 |
Anterior lens capsule staining by VisionBlue(R) in cataract surgery
Anterior capsule staining by VisionBlue(R)
Anterior lens capsule staining by VisionBlue(R) in cataract surgery
Anterior capsule staining by VisionBlue(R)
Japan |
Cataract
Ophthalmology | Adult |
Others
NO
VisionBlue(R)(DORC International) is not approved in Japan. The object of this study is verifying safety and efficacy of VisionBlue(R) .
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
An indicator of the safety is corneal endothelial cell density, compared between preoperative and one month after surgery , if it has decreased 500cells / mm2 or more.
An indicator of the effectiveness is visibility of the anterior capsule of the lens, compared before and after dyeing.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
VisionBlue(R)
20 | years-old | <= |
Not applicable |
Male and Female
Cases of mature cataract, 4-5 degrees nuclear sclerosis cataract , cataract with corneal 0r vitreous opacity ,cataract with bad isibility of the anterior capsule.
Patients under the age of 20, during pregnancy
10
1st name | |
Middle name | |
Last name | Hajime Shinoda |
Keio University School of Medicine
Department of Ophthalmology
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-1211
shinoha@mac.com
1st name | |
Middle name | |
Last name | Hidemasa Torii |
Keio University School of Medicine
Department of Ophthalmology
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-1211
hidemasatorii@yahoo.co.jp
Keio University School of Medicine
Keio University School of Medicine
Self funding
NO
2014 | Year | 10 | Month | 06 | Day |
Unpublished
2 cases in 10 cases were dropped out.
three cases in eight cases showed a decrease of the number of corneal endothelial cells .But, the visibility of the lens anterior capsule was good in all cases.
Completed
2014 | Year | 09 | Month | 29 | Day |
2014 | Year | 10 | Month | 07 | Day |
2015 | Year | 03 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 06 | Day |
2015 | Year | 10 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017860
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