UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Title of the study (Brief title)	An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Region	Japan

Condition
Condition	glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To aggregate analysis using clinical and biological information obtained with our previous research.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To aggregate analysis using clinical and biological information obtained with our previous research.
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	0 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Glaucomatous optic change 2) Visual field defects, comfirmed in at least two visula field examinations, for glaucoma. Visual field within the normal limits for preperimetric glaucoma 3) Patients who give written informed consent
Key exclusion criteria	1) Patients who unable to be accepted by doctor 2) Patients who unable to measure intraocular pressure 3) Patients with unable to assess ocular fundus due to corneal or lens opacity 4) Patients with poorly understand the study and unable to give written informed consent.
Target sample size	3000

Research contact person
Name of lead principal investigator	Nishiguchi KM
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	1-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
TEL	022-717-7294
Email	nishiguchi@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Yukihiro Shiga
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	1-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
TEL	022-717-7294
Homepage URL
Email	y.shiga@oph.med.tohoku.ac.jp

Sponsor
Institute	No institute
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	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2019 Year 03 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 22 Day
Anticipated trial start date	2015 Year 01 Month 27 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	An aggregate analysis of clinical and biological data obtained with our previous research in ongoing.

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

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025116