UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of accuracy of intraocular lens power calculation and measurement time using a new integrated device consisting of the optical axial length measurement apparatus and a corneal topography with those using an existing measurement devices for cataract patients
Title of the study (Brief title)	Outcomes of accuracy of intraocular lens power calculation and measurement time using a new integrated device consisting of the optical axial length measurement apparatus and a corneal topography
Region	Japan

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

Objectives
Narrative objectives1	To compare the measurement time and accuracy of intraocular lens power calculation using Galilli 6 with those using conventional devices(IOL master and CASIA)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Difference in the measurement time 2) Difference in accuracy in intraocular lens power calculation
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
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who undergo phacoemulsification and aspiration with intraocularlens implantation 2)Patients with a monofocal intraocular lens 3)Patients with good locomotive function related to the measurement 4)Patinets who are able to and give consent to participation in this study.
Key exclusion criteria	1)Patients with a systemic or ocular disease, or a history of surgery that may influence visual function 2)Patients who are using drugs that may influence visual function 3)Decrease in cognitive function and locomotive disability that may affect the results of the study 4)Contact lens users who can't stop using contact lenses for definite term before measurements
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35, Shinano-machi, Shinnjuku-ku, Tokyo, Japan
TEL	03-5363-3821
Email	fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person	Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
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
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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 22 Day
Anticipated trial start date	2013 Year 06 Month 22 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	none

Management information
Registered date	2014 Year 12 Month 15 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018533