UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	High-precision of intraocular lens power determination in cataract surgery
Title of the study (Brief title)	High-precision of intraocular lens power determination in cataract surgery
Region	Japan

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

Objectives
Narrative objectives1	It is aimed to improve the postoperative visual function by accurately determining the power of the intraocular lens to be inserted in cataract surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative visual ability and refraction
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	0 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patient who was planed to receive cataract surgery and could be examined before and after the operation.
Key exclusion criteria	The patient who had another disease expect for cataract.
Target sample size	200

Research contact person
Name of lead principal investigator	Shuntaro Tsunehiro
Organization	University of Kitasato School of Medicine
Division name	Department of Ophthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.
TEL	+81-42-778-8464
Email	tsune@med.kitasato-u.ac.jp

Public contact
Name of contact person	Shuntaro Tsunehiro
Organization	University of Kitasato School of Medicine
Division name	Department of Ophthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.
TEL	+81-42-778-8464
Homepage URL
Email	tsune@med.kitasato-u.ac.jp

Sponsor
Institute	University of Kitasato School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sanno Hospital
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 09 Month 20 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2014 Year 04 Month 28 Day
Anticipated trial start date	2014 Year 04 Month 28 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	Unpublished

Management information
Registered date	2016 Year 09 Month 18 Day
Last modified on	2016 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027737