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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025885
Receipt No. R000029754
Scientific Title Investigation the glucose condition dependency for the correlation between serum and aqueous humor glucose levels in patients undergoing cataract surgery
Date of disclosure of the study information 2017/01/27
Last modified on 2018/07/23

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Basic information
Public title Investigation the glucose condition dependency for the correlation between serum and aqueous humor glucose levels in patients undergoing cataract surgery
Acronym Investigation the glucose condition dependency for the correlation between serum and aqueous humor glucose levels in patients undergoing cataract surgery
Scientific Title Investigation the glucose condition dependency for the correlation between serum and aqueous humor glucose levels in patients undergoing cataract surgery
Scientific Title:Acronym Investigation the glucose condition dependency for the correlation between serum and aqueous humor glucose levels in patients undergoing cataract surgery
Region
Japan

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

Objectives
Narrative objectives1 To investigate the glucose dependency for the correlation between serum and aqueous humor glucose levels in patients undergoing cataract surgery. Simultaneously, to examine the time lag of the glucose level changes between serum and aqueous humor.
Basic objectives2 Others
Basic objectives -Others Correlation between serum and aqueous humor glucose levels
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The difference of the relationships between aqueous humor and serum glucose levels segmented by the glucose conditions
Key secondary outcomes The change of the glucose level before and after the cataract surgery

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undertake cataract surgery
Key exclusion criteria ・Angle closure patients
・Ocular disorder besides cataract
・Patients who have extremely high or low tear secretion
・Patients who need alternatives for the agreement
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuno Negishi
Organization Keio university School of Medicine
Division name Department of ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3821
Email fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihide Kurihara
Organization Keio university School of Medicine
Division name Department of ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3821
Homepage URL
Email kurihara@z8.keio.jp

Sponsor
Institute Keio university School of Medicine
Institute
Department

Funding Source
Organization Fuji Xerox Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 01 Month 27 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 Completed
Date of protocol fixation
2017 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 27 Day
Last follow-up date
2018 Year 07 Month 12 Day
Date of closure to data entry
2018 Year 07 Month 12 Day
Date trial data considered complete
2018 Year 07 Month 12 Day
Date analysis concluded
2018 Year 07 Month 12 Day

Other
Other related information N/A

Management information
Registered date
2017 Year 01 Month 27 Day
Last modified on
2018 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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