UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the cleanliness of the operative field in cataract surgery between intraoperative iodine and preoperative antibiotic drops..
Title of the study (Brief title)	Comparison between intaraoperative iodine and preoperative antibiotic drops.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the hypothesis that the intraoperative iodine application attains the efficient cleanliness of the operative field during the cataract surgery without preoperative antibiotic eyedrops.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The copy number of the polymerase chain reaction and bacterial flora amount of the operative field in cataract surgery.
Key secondary outcomes	vision grade of flare endophthalmitis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Maneuver
Interventions/Control_1	Former eye: Intraoperative iodine compound disinfection for surgical field without preoperative antibiotics
Interventions/Control_2	Second eye: Preoperative antibiotic application without intraoperative iodine disinfection.
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	Kauki Matsuura
Organization	NOjimahospital
Division name	Ophthalmology
Address	2514-1, Sezaki-cho, Kurayoshi, Tottori
TEL	0858-22-6231
Email	matsu224@ncn-k.net

Public contact
Name of contact person	Kauki Matsuura
Organization	NOjimahospital
Division name	Ophthalmology
Address	2514-1, Sezaki-cho, Kurayoshi, Tottori
TEL	0858-22-6231
Homepage URL
Email	matsu224@ncn-k.net

Sponsor
Institute	Nojima hospital
Institute
Department

Funding Source
Organization	Nojima hospital
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 12 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 29 Day
Anticipated trial start date	2017 Year 09 Month 30 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	2017 Year 10 Month 10 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=R000033094