UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Scarring of filtering blebs after trabeculectomy
Title of the study (Brief title)	Bleb scarring
Region	Japan

Condition
Condition	glaucoma or ptrigium
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To obtain human tenon's fibroblast (HTF) cells.
Basic objectives2	Others
Basic objectives -Others	To investigate mRNA or protein expressions in HTF cells.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	protein and mRNA expressions
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient who are scheduled for glaucoma filtering surgery or pteriguim resection.
Key exclusion criteria	Patients who cannot or do not consent.
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshiaki Kiuchi
Organization	Hiroshima University
Division name	Department of Ophthalmology
Address	1-2-3 Kasumi Minamiku Hiroshima
TEL	082-257-5247
Email	ykiuchi@hiroshima-u.ac.jp

Public contact
Name of contact person	YANAGI, Masahide
Organization	Hiroshima University
Division name	Department of Ophthalmology
Address	1-2-3 Kasumi Minamiku Hiroshima
TEL	082-257-5247
Homepage URL
Email	myaja111@yahoo.co.jp

Sponsor
Institute	Hiroshima University, Department of Ophthalmology
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	Departmental fund
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

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 05 Month 01 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
Other related information	We are going to culture human tenon's fibroblast cells from surgically obtained Tenon's capsule.

Management information
Registered date	2012 Year 04 Month 20 Day
Last modified on	2016 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009188