UMIN-CTR Clinical Trial

Basic information
Public title	Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Acronym	Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Scientific Title	Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Scientific Title:Acronym	Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate postoperative visual function in eyes with monofocal and multifocal intraocular lenses using functional visual acuity measurement and to elucidate detailed visual function in eyes with multifocal intraocular lens.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	functional visual acuity
Key secondary outcomes

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
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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 will undergo cataract surgery at our hospital. Over 1.0 of expected postoperative visual acuity Patients whose axial length is 22.5 mm and longer as well as shorter than 30 mm.
Key exclusion criteria	Patients under 20 years old, difficulity in obtaining conscent for this study. Patients who have systemic or ocular complications that affect their visual functions intraoperative complicaions.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	35, Shinano-machi, Shinnjuku-ku, Tokyo, Japan
TEL	03-5363-
Email	fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	35, Shinano-machi, Shinnjuku-ku, Tokyo, Japan
TEL	03-5363-3821
Homepage URL
Email	fwic7788@mb.infoweb.ne.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
Email

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	慶応義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 20 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	Terminated
Date of protocol fixation	2015 Year 11 Month 09 Day
Date of IRB	2016 Year 01 Month 08 Day
Anticipated trial start date	2016 Year 01 Month 20 Day
Last follow-up date	2020 Year 05 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Refraction, visual acuity, contrast visual acuity, functional visual acuity , Schirmer test, tear break up time, and slit lamp findings of the patients who are planned to undergo cataract surgery at Keio University Hospital will be evaluated preoperatively and 1 month postoperatively.

Management information
Registered date	2016 Year 01 Month 19 Day
Last modified on	2020 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023742