UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014320 |
|---|---|
| Receipt number | R000016668 |
| Scientific Title | The possibility of recovery from visual field defect by fluid replacement with low cerebrospinal fluid pressure syndrome |
| Date of disclosure of the study information | 2014/06/19 |
| Last modified on | 2023/07/10 05:34:51 |
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Basic information
Public title
The possibility of recovery from visual field defect by fluid replacement with low cerebrospinal fluid pressure syndrome
Acronym
The possibility of recovery from visual field defect by fluid replacement with low cerebrospinal fluid pressure syndrome
Scientific Title
The possibility of recovery from visual field defect by fluid replacement with low cerebrospinal fluid pressure syndrome
Scientific Title:Acronym
The possibility of recovery from visual field defect by fluid replacement with low cerebrospinal fluid pressure syndrome
Region
| Japan |
Condition
Condition
Low cerebrospinal fluid syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We intend to examine the relation between low cerebrospinal fluid syndrome and optic nerve disorder, and to create the new diagnostic method of optic nerve disorder with low cerebrospinal fluid syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of visual acuity and the value of MD by fluid replacement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous drip injection of 500ml of Solita-T No.3 and 500ml of Bicarbon for 90 minutes
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
| 10 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient with low cerebrospinal pressure syndrome
The person is diagnosed as visual field defect of traumatic low cerebrospinal pressure syndrome by cervical sprain of traffic accident and so on.
The patient with glaucome
The person is diagnosed as open angle glaucoma.
Key exclusion criteria
1. The patient with hypermagnesemia or hypothyloidism
2. The patient with lactacidemia, Addison disease, hyperkalemia, azotemia, severe burn or oliguria
3. The patient with heart failure
4. The patient that is not appropriate as the subject by the judgement of principal researcher
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shinmei |
Organization
Assistant Professor, the department of Ophthalmology of Hokkaido University Hospital
Division name
Ophthalmology
Zip code
Address
West 5 North 14 kitaku sapporoshi Hokkaido
TEL
011-716-1161
yshinmei@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinmei Yasuhiro |
Organization
Hokkaido University Hospital
Division name
Ophthalmology
Zip code
Address
West 5 North 14 kitaku sapporoshi Hokkaido
TEL
011-706-5944
Homepage URL
yshinmei@med.hokudai.ac.jp
Sponsor or person
Institute
The department of Ophthalmology of Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
| 2014 | Year | 06 | Month | 19 | 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
| 2014 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016668
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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