UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the change of the aqueous humor spillage before and after the glaucoma treatment
Title of the study (Brief title)	Examination of the change of the aqueous humor spillage before and after the glaucoma treatment
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluate
Basic objectives2	Others
Basic objectives -Others	study of
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	check
Key secondary outcomes	intraocular pressure

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	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	in patients with glaucoma,who have eye drop or operation
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	glaucoma patients
Key exclusion criteria	LASIK injured
Target sample size	30

Research contact person
Name of lead principal investigator	Chin Shinki
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of ophthalmology
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-704-5944
Email	schin@med.hokudai.ac.jp

Public contact
Name of contact person	Kasumi Kikuchi
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-704-5944
Homepage URL
Email	kakikuchi-spr@umin.ac.jp

Sponsor
Institute	Department of Ophthalmology Hokkaido University Graduate School 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	Department of Ophthalmology Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 17 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	no results
Other related information

Management information
Registered date	2016 Year 02 Month 17 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023967