UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013037 |
|---|---|
| Receipt number | 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 10:44:02 |
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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
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
hyosikaw@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015077
