UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of multifocal intraocular lens in cataract surgery
Acronym	multifocal intraocular lens in cataract surgery
Scientific Title	Efficacy of multifocal intraocular lens in cataract surgery
Scientific Title:Acronym	multifocal intraocular lens in cataract surgery
Region	Japan

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

Objectives
Narrative objectives1	Efficacy of multifocal intraocular lens
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Visual acuity
Key secondary outcomes	refraction

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	From Dec/2011 untill Aug/2016 fifteen cases of multifocal intraocular lens in cataract surgery
Interventions/Control_2	From Dec/2011 untill Aug/2016 fifteen cases of monofocal intraocular lens in cataract surgery
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	corneal curvature within -1.00D
Key exclusion criteria	High frequency of driving in night Dislike of clothing glasses and contact lens
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Toshinori Middle name Last name Murata
Organization	Shinshu university
Division name	Ophthalmology
Zip code	390-8621
Address	1-1-3 Asahi Matsumoto-shi Nagano JAPAN
TEL	0263-37-2664
Email	ieganka@shinshu-u.ac.jp

Public contact
1st name of contact person	1st name Toshiyuki Middle name Last name Kyomoto
Organization	Shinshu University
Division name	Ophthalmology
Zip code	390-8621
Address	1-1-3 Asahi Matsumoto-shi Nagano JAPAN
TEL	0263-37-2664
Homepage URL
Email	ieganka@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University Ophthalmology
Institute
Department

Funding Source
Organization	Shinshu University hospital
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinshu University Ophthalmology
Address	1-1-3 Asahi Matsumoto-shi Nagano JAPAN
Tel	0263-35-4600
Email	ieganka@shinshu-u.ac.jp

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	2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2011 Year 12 Month 01 Day
Date of IRB	2011 Year 12 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 01 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2011 Year 10 Month 28 Day
Last modified on	2019 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007841