UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039093 |
|---|---|
| Receipt number | R000038464 |
| Scientific Title | The effect of ripasudil for patient with open-angle glaucoma after circumferential trabeculotomy |
| Date of disclosure of the study information | 2020/01/09 |
| Last modified on | 2021/02/27 10:19:16 |
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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
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
zxsato@gmail.com
Sponsor or person
Institute
Sato Eye and Internal Medicine Clinic / Sato Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038464
