UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	analysis of intraocular pressure and oxygen distribution
Title of the study (Brief title)	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	Shigeru Kinoshita
Organization	Kyoto Prefectural University of Medicine
Division name	Ophthalmology
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	Haruna Yoshikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 12 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015077