UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023227 |
|---|---|
| Receipt number | 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 22:39:46 |
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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
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
suimonyuka@gmail.com
Sponsor or person
Institute
Department of Ophthalmology Hokkaido university Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024749
