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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007567
Receipt No. R000008916
Scientific Title The detection of polyols in diabetic cataract and keratopathy.
Date of disclosure of the study information 2012/03/27
Last modified on 2015/01/05

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Basic information
Public title The detection of polyols in diabetic cataract and keratopathy.
Acronym Polyols in diabetic cataract and keratopathy.
Scientific Title The detection of polyols in diabetic cataract and keratopathy.
Scientific Title:Acronym Polyols in diabetic cataract and keratopathy.
Region
Japan

Condition
Condition Diabetic cataract, Diabetic keratopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To detect and measure the amount of polyols accumulated in the tissue of cornea and cataract obtained from diabetic patients.
Basic objectives2 Others
Basic objectives -Others Bio- quantification
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The amount of polyols in the tissue of lens and cornea.
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
30 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with Diabetes Mellitus who were diagnosed diabetic cataract or keratopathy.
Key exclusion criteria a history of ocular surgery and inflammation, the presence of other ocular diseases.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL 0776-61-8403
Email ytakamura@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Shimoaiduki Matsuoka Yoshida Fukui
TEL 0776-61-8403
Homepage URL
Email ytakamura@hotmail.com

Sponsor
Institute Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department

Funding Source
Organization Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 03 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
2012 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We examine the amount of polyols in lens and cornea of diabetic patients.

Management information
Registered date
2012 Year 03 Month 24 Day
Last modified on
2015 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008916

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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