UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research
Title of the study (Brief title)	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	Tetsuro Oshika, Yuichi Ohashi
Organization	Tsukuba University, Ehime University
Division name	School of medicine
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	Eiji Namba
Organization	HOYA CORPORATION
Division name	Medical Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014783