UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness ofintraoperative iodine compound disinfection to prevent post operative infection after cataract surgery
Title of the study (Brief title)	Effectiveness of intraoperative iodine compound disinfection
Region	Japan

Condition
Condition	Cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate ocular surface flora amount in the surgical field and develop efficient and safe intraoperative antiseptic measure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bacterial flora amount and colony count in the surgical field
Key secondary outcomes

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Maneuver
Interventions/Control_1	Intraoperative iodine compound disinfection for surgical field
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing cataract surgery
Key exclusion criteria	Patients with pre-existing blepharitis, conjunctivitis, keratitis, or uveitis
Target sample size	200

Research contact person
Name of lead principal investigator	Yoshitsugu Inoue
Organization	Tottori university
Division name	Division of Ophthalmology and Visual Science
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859-38-6617
Email	yoinoue@grape.med.tottori-u.ac.jp

Public contact
Name of contact person	Dai Miyazaki
Organization	Tottori university
Division name	Division of Ophthalmology and Visual Science
Address	36-1 Nishi-cho, Yonago, Tottori pref.
TEL	0859-38-6617
Homepage URL
Email	dm@med.tottori-u.ac.jp

Sponsor
Institute	Tottori university, Division of Ophthalmology and Visual Science
Institute
Department

Funding Source
Organization	NIHON TENGANYAKU KENKYUSYO CO. LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	野島病院（鳥取県）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 06 Day
Anticipated trial start date	2014 Year 01 Month 10 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 06 Day
Last modified on	2017 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015496