UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015528 |
|---|---|
| Receipt number | R000018028 |
| Scientific Title | The efficacy of hydrogen eye drop for the ischemia-reperfusion injury of retinal artery occlusion |
| Date of disclosure of the study information | 2014/10/27 |
| Last modified on | 2014/11/01 16:12:39 |
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Basic information
Public title
The efficacy of hydrogen eye drop for the ischemia-reperfusion injury of retinal artery occlusion
Acronym
The efficacy of hydrogen eye drop for retinal artery occlusion
Scientific Title
The efficacy of hydrogen eye drop for the ischemia-reperfusion injury of retinal artery occlusion
Scientific Title:Acronym
The efficacy of hydrogen eye drop for retinal artery occlusion
Region
| Japan |
Condition
Condition
Retinal artery occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the efficiency of hydrogen eye drop for ischemia-reperfusion injury of retinal artery occlusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
visual acuity
Key secondary outcomes
inner retinal layer, retinal electogram
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
hydrogen
Interventions/Control_2
saline solution
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 with retinal artery occlusion.
Key exclusion criteria
Patients without thrombolytic therapy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takahashi |
Organization
Nippon Medical School
Division name
Ophthalmology
Zip code
Address
1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL
03-3822-2131
tutomu@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonaga Takase |
Organization
Nippon Medical School Hospital
Division name
IRB
Zip code
Address
1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL
03-3822-2131
Homepage URL
clinicaltrial@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 10 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 27 | 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
| 2014 | Year | 10 | Month | 26 | Day |
Last modified on
| 2014 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018028
