UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Title of the study (Brief title)	Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Region	Japan

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

Objectives
Narrative objectives1	To investigate surgical results of multifocal intraocular lens implantation and patient's satisfaction in Japan
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Corrected Visual acuity (Distance,near) Uncorrected Visual acuity (Distance,near)
Key secondary outcomes	usage of spectacles,questionnaire,refraction,contrast sensitivity

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who undergo cataract surgery with multifocal intraocular lens implantation at the institute registered to the registry system of advanced medical treatment( cataract surgery with multifocal intraocular lens implantation) that is administrated by the Japanese society of cataract and refractive surgery.
Key exclusion criteria	Patients who don't give their consent to this study
Target sample size	5000

Research contact person
Name of lead principal investigator	Hiroko Bissen-Miyajima
Organization	Tokyo Dental College Suidobashi Hospital
Division name	Department of ophthalmology
Address	2-9-18, Misakicho, Chiyoda-ku, Tokyo, Japan
TEL	03-5275-1856
Email	bissen@tdc.ac.jp

Public contact
Name of contact person	Hiroki Yamanishi
Organization	Japanese Society of Cataract and Refractive Surgery(JSCRS) questionnaire survey working group
Division name	Secretariat, Japanese Society of Cataract and Refractive Surgery(JSCRS)
Address	3-2-16, Misakicho, Chiyoda-ku, Tokyo Japan
TEL	03-5226-7750
Homepage URL
Email	jscrs@jscrs.jp

Sponsor
Institute	Keio university school of medicine
Institute
Department

Funding Source
Organization	Keio university school of medicine
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	慶應委義塾大学病院ほか、日本屈折矯正手術学会より日本白内障屈折矯正手術学会の先進医療（多焦点眼内レンズを用いた水晶体再建術）登録システムに登録された施設

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 01 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	none

Management information
Registered date	2017 Year 02 Month 20 Day
Last modified on	2019 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030013