UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of multifocal intraocular lenses on standard automated perimetry test
Title of the study (Brief title)	Influence of multifocal intraocular lenses on standard automated perimetry test
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the influence of implanted multifocal intraocular lenses on glaucoma patients using standard automated perimetry (SAP)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mean deviation, visual field index and pattern standard deviation.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)Glaucoma patients implanted a multifocal IOL 2)written informed consent from patient.
Key exclusion criteria	Exclusion criteria were patient refusal and any anticipated difficulties with examination or follow up
Target sample size	20

Research contact person
Name of lead principal investigator	Naito Tomoko
Organization	Okayama University
Division name	Ophthalmology
Address	2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL	81-86-235-7297
Email	opth@cc.okayama-u.ac.jp

Public contact
Name of contact person	Miki Takako
Organization	Okayama University
Division name	Ophthalmology
Address	2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL	81-86-235-7297
Homepage URL
Email	opth@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
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	Okayama University
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 08 Day
Anticipated trial start date	2016 Year 06 Month 08 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	prospective study of changes for glaucoma patients implanted a multifocal IOL

Management information
Registered date	2016 Year 06 Month 28 Day
Last modified on	2016 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025833