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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013037
Receipt No. R000015077
Scientific Title analysis of intraocular pressure and oxygen distribution
Date of disclosure of the study information 2014/02/28
Last modified on 2018/02/06

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Basic information
Public title analysis of intraocular pressure and oxygen distribution
Acronym analysis of intraocular pressure and oxygen distribution
Scientific Title analysis of intraocular pressure and oxygen distribution
Scientific Title:Acronym analysis of intraocular pressure and oxygen distribution
Region
Japan

Condition
Condition corneal diseases, cataract, glaucoma and vitreo-retinal diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between intraocular oxygen distribution and pressure and pathogenesis of corneal diseases, cataract glaucoma and vitero-retinal diseases by direct measurement of analysis of intraocular oxygen distribution and pressure
Basic objectives2 Others
Basic objectives -Others identification of pathophysiologic mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes analysis of intraocular pressure and oxygen distribution
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients of corneal diseases, cataract, glaucoma and vitero-retinal diseases to be subjected for operations with writtened informed consents
Key exclusion criteria none
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kinoshita
Organization Kyoto Prefectural University of Medicine
Division name Ophthalmology
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku
TEL 075-251-5579
Email shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruna Yoshikawa
Organization Kyoto Prefectural University of Medicine
Division name Ophthalmology
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku
TEL 075-251-5579
Homepage URL
Email hyosikaw@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 京都府立医科大学付属病院(京都府)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 28 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
2013 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2016 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Intraocular pressure and oxygen distribution will be measured under an operating microscope at the time of surgery. After routine sterile prep and draping, a peripheral corneal paracentesis will be fashioned with a 20G keratome. Intraocular pressure will be measured using Samba Preclin fibre-optic pressure transducer. The oxygen distribution will be evaluated using an Oxylab pO2TM optical oxygen sensor.

Management information
Registered date
2014 Year 01 Month 31 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015077

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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