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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012723
Receipt No. 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

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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)
Email 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
Email eiji.namba@hoya.com

Sponsor
Institute Tsukuba University, Ehime University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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