UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Basic analysis of vitreous fluid and retina for chorioretinal disorders
Title of the study (Brief title)	Basic analysis of vitreous fluid and retina
Region	Japan

Condition
Condition	chorioretinal disorders includins uveitis, retinal detachment, or diabetic retinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the pathogenesis of chorioretinal disorders by the analysis of ocular tissues.
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Inflammatory cytokine levels, flow cytometric analysis, PCR, and immunohistochemical analysis of intraocular tissues.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chorioretinal disorders includins uveitis, retinal detachment, or diabetic retinopathy.
Key exclusion criteria	Patients who is determined inappropriate to participate in this study by attending physician.
Target sample size	500

Research contact person
Name of lead principal investigator	Chie Sotozono
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto city, Kyoto 602-0841, Japan
TEL	075-251-5578
Email	csotozon@koto.kpu-m.ac.jp

Public contact
Name of contact person	Kenji Nagata
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto city, Kyoto 602-0841, Japan
TEL	075-251-5578
Homepage URL
Email	kenji68@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 03 Month 02 Day
Anticipated trial start date	2011 Year 03 Month 02 Day
Last follow-up date
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	We demonstrated that CD4/CD8 ratio of vitreous-infiltrating lymphocytes has high diagnostic value in ocular sarcoidosis.
Other related information	prospective study

Management information
Registered date	2016 Year 04 Month 11 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025222