Unique ID issued by UMIN | UMIN000012723 |
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Receipt number | R000014783 |
Scientific Title | Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research |
Date of disclosure of the study information | 2014/01/06 |
Last modified on | 2017/01/05 17:44:53 |
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Japan |
cataract
Ophthalmology |
Others
NO
To confirm the safety of iSert Micro 255 base on multicenter data
Safety
Rate of postoperative endophthalmitis
Rate of postoperative adverse events
Observational
40 | years-old | <= |
90 | years-old | >= |
Male and Female
(1) Patient in the age is from 40 to 90 at the time of consent acquisition
(2) Patient who cooperate in postoperative follow-up (A patient who can visit a hospital at least postoperative 2nd month)
(1) Patient who already extracted his/her crystalline lens and has become an aphakic eye or a fake (artificial) crystalline lens eye
(2) Patient who simultaneously undergoes other eye surgery or intravitreal injection of various medicines
(3) Patient with following preexisting conditions
*Patient with active uveitis
*Patient with rubeosis iriditis
*Patient with uncontrollable glaucoma
*Patient with progressive diabetic retinopathy
(4) Patient who is assessed as ineligible for this research by an research doctor
(5) Patient who decline to cooperate with the research
9000
1st name | |
Middle name | |
Last name | Tetsuro Oshika, Yuichi Ohashi |
Tsukuba University, Ehime University
School of medicine
1-1-1 Tennodai, Tsukuba city, Ibaraki 305-8575, Japan/ Shitsukawa, Toon, Ehime, 791-0295 Japan
029-853-3148(089-964-5111)
oshika@eye.ac
1st name | |
Middle name | |
Last name | Eiji Namba |
HOYA CORPORATION
Medical Division
Nakano Central Park Building 6F, 4-10-2 Nakano, Nakano-ku, Tokyo 164-8545 Japan
03-5913-2347
eiji.namba@hoya.com
Tsukuba University, Ehime University
HOYA CORPORATION Medical Division
Profit organization
KUREHA SPECIAL LABORATORY CO.,LTD.
NO
2014 | Year | 01 | Month | 06 | Day |
Published
Completed
2013 | Year | 10 | Month | 25 | Day |
2014 | Year | 01 | Month | 06 | Day |
Outbreak of late onset toxic anterior segment syndrome after implantation of one piece intraocular lenses.
Suzuki T, Ohashi Y, Oshika T, Goto H, Hirakata A, Fukushita K, Miyata K; Japanese Ophthalmological Society HOYA Intraocular Lens Related Endophthalmitis Investigation Commission.
Am J Ophthalmol. 2015 May;159(5):934 9.e2. doi: 10.1016/j.ajo.2015.01.023. Epub 2015 Jan 28
2013 | Year | 12 | Month | 29 | Day |
2017 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014783
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