UMIN-CTR Clinical Trial

Basic information
Public title	Determination of age-related factors in cataract.
Acronym	Determination of age-related factors in cataract.
Scientific Title	Determination of age-related factors in cataract.
Scientific Title:Acronym	Determination of age-related factors in cataract.
Region	Japan

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

Objectives
Narrative objectives1	To determine the age-related molecular factors in cataract
Basic objectives2	Others
Basic objectives -Others	To determine the molecular factors related to aging process in lens materials obtained during cataract surgery.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To determine the age-related factors in cataract.
Key secondary outcomes	To determine the molecular factors related to aging process such as amyloid and D-amino acids in cataract.

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients receiving cataract surgery.
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Kaji
Organization	University of Tsukuba
Division name	Majors in Medical Sciences
Zip code	3050006
Address	1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL	0298533148
Email	kajiyuichi@gmai.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Kaji
Organization	University of Tsukuba
Division name	Majors in Medical Sciences
Zip code	3050006
Address	1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL	0298533148
Homepage URL
Email	kajiyuichi@gmai.com

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tsukuba Univ
Address	Tennoudai 1-1-1
Tel	0298533148
Email	kajiyuichi@gmail.com

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	2015 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2016 Year 03 Month 15 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2020 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Age, Sex, Types of cataract

Management information
Registered date	2015 Year 09 Month 17 Day
Last modified on	2020 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022030