UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of multifocal intraocular lens implantation for cataract patients
Acronym	Efficacy of multifocal iontraocular lens
Scientific Title	Efficacy of multifocal intraocular lens implantation for cataract patients
Scientific Title:Acronym	Efficacy of multifocal iontraocular lens
Region	Japan

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

Objectives
Narrative objectives1	To evaluate near and far postoperative visual acuity, satisfaction after multifocal intraocular lens implantation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intra and postoperative complication postoperative non-corrected visual acuity (near, far, refraction) satisfuction
Key secondary outcomes

Base
Study type	Interventional

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	Device,equipment
Interventions/Control_1	implantation of multifocal intraocular lens after cataract removal
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	cataract patients who understand the contents of this study
Key exclusion criteria	patients with another ocular diseases exept cataract patients with corneal astigmatism over than -0.5D patients who cannot understand the efficacy and disadvantage of multifocal intraocular lens patients judged as inadequate for the participents
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Koh-Hei Middle name Last name Sonoda
Organization	Yamaguchi University
Division name	Department of Ophthalmology
Zip code	7558505
Address	1-1-1 Minami-Kogushi, Ube City
TEL	0836-22-2278
Email	sonodak@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name Morishige
Organization	School of Medicine
Division name	Ophthalmology
Zip code	7558505
Address	1-1-1 Minami-Kogushi
TEL	0836-22-2278
Homepage URL
Email	morishig@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Center For Clinical Research. Yamaguchi University Hospital
Address	1-1-1Minami-Kogushi, Ube city, Yamaguchi prefecture
Tel	0836-22-2428
Email	me223@yamaguchi-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	2013 Year 09 Month 12 Day

Related information
URL releasing protocol	none
Publication of results	Unpublished

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	7
Results	For patients with a multifocal intraocular lens inserted, we listened to postoperative visual function such as distant, near and intermediate visual acuity and patient satisfaction. We were able to examine the usefulness of multifocal intraocular lenses and the appropriateness of intraocular lens selection.
Results date posted	2021 Year 09 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Cataract patients
Participant flow	1.Surgery application 2.Cataract surgery 3.Postoperative evaluation
Adverse events	none
Outcome measures	visual acuity Level of satisfaction
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 10 Day
Date of IRB	2012 Year 04 Month 05 Day
Anticipated trial start date	2012 Year 08 Month 26 Day
Last follow-up date	2014 Year 02 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 12 Day
Last modified on	2021 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013723