UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042504 |
|---|---|
| Receipt number | R000048523 |
| Scientific Title | Effect of ripasudil on corneal endothelial damage after glaucoma tube shunt surgery |
| Date of disclosure of the study information | 2020/12/25 |
| Last modified on | 2023/11/21 15:45:10 |
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Basic information
Public title
Effect of ripasudil on corneal endothelial damage after glaucoma tube shunt surgery
Acronym
Effect of ripasudil on corneal endothelial damage after glaucoma tube shunt surgery
Scientific Title
Effect of ripasudil on corneal endothelial damage after glaucoma tube shunt surgery
Scientific Title:Acronym
Effect of ripasudil on corneal endothelial damage after tube shunt surgery
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ripasudil on corneal endothelial damage after glaucoma tube shunt surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
corneal endothelial cell density during 2 years after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ripasudil eye drop 2 times/day for 2 years
Interventions/Control_2
no ripasudil eye drop
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who can be obtained informed consent
patients who have glaucoma tube shunt surgery
Key exclusion criteria
significant corneal endothelial damage
pregnancy
eye surgery within 6 months
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Hirooka |
Organization
Hiroshima University Hospital
Division name
ophthalmology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
onoehir@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Hirooka |
Organization
Hiroshima University Hospital
Division name
ophthalmology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
Homepage URL
kazuyk@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel
0822571551
iryo-seisaku@office.hiroshima-u.ac.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
愛媛大学医学部附属病院（愛媛県）、ツカザキ病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048523
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
