UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012723 |
|---|---|
| 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 |
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Basic information
Public title
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Acronym
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Scientific Title
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Scientific Title:Acronym
Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of iSert Micro 255 base on multicenter data
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of postoperative endophthalmitis
Key secondary outcomes
Rate of postoperative adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(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)
Key exclusion criteria
(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
Target sample size
9000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Oshika, Yuichi Ohashi |
Organization
Tsukuba University, Ehime University
Division name
School of medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba city, Ibaraki 305-8575, Japan/ Shitsukawa, Toon, Ehime, 791-0295 Japan
TEL
029-853-3148(089-964-5111)
oshika@eye.ac
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Namba |
Organization
HOYA CORPORATION
Division name
Medical Division
Zip code
Address
Nakano Central Park Building 6F, 4-10-2 Nakano, Nakano-ku, Tokyo 164-8545 Japan
TEL
03-5913-2347
Homepage URL
eiji.namba@hoya.com
Sponsor or person
Institute
Tsukuba University, Ehime University
Institute
Department
Personal name
Funding Source
Organization
HOYA CORPORATION Medical Division
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KUREHA SPECIAL LABORATORY CO.,LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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
Management information
Registered date
| 2013 | Year | 12 | Month | 29 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014783
