UMIN-CTR Clinical Trial

Basic information
Public title	The effect of ripasudil for patient with open-angle glaucoma after circumferential trabeculotomy
Acronym	The effect of ripasudil after circumferential trabeculotomy
Scientific Title	The effect of ripasudil for patient with open-angle glaucoma after circumferential trabeculotomy
Scientific Title:Acronym	The effect of ripasudil after circumferential trabeculotomy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the intraocular pressure (IOP)-lowering effect of ripasudil in patients with open-angle glaucoma after incising the circumferential inner wall of the Schlemm's canal.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IOP, the number of glaucoma medications
Key secondary outcomes

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

Eligibility
Age-lower limit	21 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Open-angle glaucoma without prior glaucoma surgery
Key exclusion criteria	Other types of glaucoma; a history of previous glaucoma surgery; or an ocular condition that would compromise their safety or interfere with study testing
Target sample size	30

Research contact person
Name of lead principal investigator	1st name TOMOKI Middle name Last name SATO
Organization	Sato Eye and Internal Medicine Clinic / Sato Eye Clinic
Division name	None
Zip code	8640041
Address	4160-270 Arao, Arao City, Kumamoto
TEL	0968655900
Email	zxsato@gmail.com

Public contact
Name of contact person	1st name TOMOKI Middle name Last name SATO
Organization	Sato Eye and Internal Medicine Clinic / Sato Eye Clinic
Division name	None
Zip code	8640041
Address	4160-270 Arao, Arao City, Kumamoto
TEL	0968655900
Homepage URL
Email	zxsato@gmail.com

Sponsor
Institute	Sato Eye and Internal Medicine Clinic / Sato Eye Clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Institutional Review Board and the Ethics Committee of Sato Eye and Internal Medicine Clinic
Address	4160-270 Arao, Arao City, Kumamoto
Tel	0968655900
Email	sato083@yahoo.co.jp

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	2020 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 01 Month 09 Day
Last modified on	2021 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038464

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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