UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	visual function and satisfaction with bifocal contact lenses after cataract surgery
Title of the study (Brief title)	bifocal contact lenses after cataract surgery
Region	Japan

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

Objectives
Narrative objectives1	To investigate visual function and satisfaction with bifocal contact lenses after cataract surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual acuity
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	To hope correction of Presbyopia after implanting monofocal IOL Corneal astigmatism less than 1.5 Best corrected decimal visual acuity more than 0.8
Key exclusion criteria	Cases having ophthalmologic diseases except for cataract Cases judged unsuitable by the research director
Target sample size	20

Research contact person
Name of lead principal investigator	Kazutaka Kamiya
Organization	Kitasato University
Division name	Department of Ophthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	042-778-9920
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	Kazutaka Kamiya
Organization	Kitasato University
Division name	Department of Ophthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	042-778-9920
Homepage URL
Email	kamiyak-tky@umin.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kitasato University
Institute
Department

Funding Source
Organization	Kitasato 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	2019 Year 02 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 12 Month 19 Day
Anticipated trial start date	2018 Year 12 Month 19 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	To investigate visual function and satisfaction with bifocal contact lenses after cataract surgery

Management information
Registered date	2019 Year 02 Month 17 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040900