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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023227
Receipt No. R000024749
Scientific Title Comparison of the lowering intraocular pressure after trabeculotomy between patients with and without response to Ripasudil.
Date of disclosure of the study information 2016/07/20
Last modified on 2016/07/23

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Basic information
Public title Comparison of the lowering intraocular pressure after trabeculotomy between patients with and without response to Ripasudil.
Acronym Trabeculotomy between patients with and without response to Ripasudil.
Scientific Title Comparison of the lowering intraocular pressure after trabeculotomy between patients with and without response to Ripasudil.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Chin Shinki
Organization Hokkaido University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
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
1st name
Middle name
Last name Suimon Yuka
Organization Hokkaido University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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

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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