UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical outcome of multi focal intraocular lens(IOL)
Title of the study (Brief title)	Clinical outcome of multi focal intraocular lens(IOL)
Region	Japan

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

Objectives
Narrative objectives1	To investigate the clinical result of multifocal intraocular lens implantation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ25) The Quality of Vision (QoV) Questionnaire
Key secondary outcomes	visual acuity contrast aberration

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing implantation with multifocal IOL
Key exclusion criteria	Patients found to have other ocular diseases
Target sample size	150

Research contact person
Name of lead principal investigator	Santaro Noguchi
Organization	Saneikai Tsukazaki Hospital
Division name	Department of Ophthalmology
Address	68-1 Waku Aboshi-ku Himeji HYOGO,JAPAN
TEL	0792728555
Email	s.noguchi@tsukazaki-eye.net

Public contact
Name of contact person	Santaro Noguchi
Organization	Saneikai Tsukazaki Hospital
Division name	Department of Ophthalmology
Address	68-1 Waku Aboshi-ku Himeji HYOGO,JAPAN
TEL	0792728555
Homepage URL
Email	s.noguchi@tsukazaki-eye.net

Sponsor
Institute	Saneikai Tsukazaki Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Saneikai Tsukazaki Hospital
Organization
Division
Category of Funding Organization	Self funding
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	ツカザキ病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 02 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 02 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	observation test

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025068