UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the lowering intraocular pressure after trabeculotomy between patients with and without response to Ripasudil.
Title of the study (Brief title)	Trabeculotomy between patients with and without response to Ripasudil.
Region	Japan

Condition
Condition	1. Glaucoma 2. Ocular hypertention
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients who respond to Ripasudil may have lower intraocular pressure(IOP) after trabeculotomy than those with no response, because the mechanism of elevated IOP is associate with main outflow tract in the patients who respond to Ripasudil. We will compare IOP levels between patients who respond to Ripasudil and patients who do not.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular pressure after trabeculotomy
Key secondary outcomes	Intraocular pressure 4 weeks after Ripasudil is initiated C-value of tonography 4 weeks after Ripasudil is initiated C-value of tonography after trabeculotomy

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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Trabeculotomy 4 weeks after treatment with Ripasudil.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with medically uncontrolled glaucoma who need trabeculotomy
Key exclusion criteria	Patients who don't agree with the treatment Patients who need emergency glaucoma operation Patient who need trabeculectomy
Target sample size	40

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	011-706-5944
Email	schin@med.hokudai.ac.jp

Public contact
Name of contact person	Suimon Yuka
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5944
Homepage URL
Email	suimonyuka@gmail.com

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	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	2016 Year 07 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 08 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

Management information
Registered date	2016 Year 07 Month 19 Day
Last modified on	2016 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024749