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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014320
Receipt No. R000016668
Official scientific title of the study 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 2017/07/25

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Basic information
Official scientific title of the study The possibility of recovery from visual field defect by fluid replacement with low cerebrospinal fluid pressure syndrome
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Yasuhiro Shinmei
Organization Assistant Professor, the department of Ophthalmology of Hokkaido University Hospital
Division name Ophthalmology
Address West 5 North 14 kitaku sapporoshi Hokkaido
TEL 011-716-1161
Email yshinmei@med.hokudai.ac.jp

Public contact
Name of contact person Shinmei Yasuhiro
Organization Hokkaido University Hospital
Division name Ophthalmology
Address West 5 North 14 kitaku sapporoshi Hokkaido
TEL 011-706-5944
Homepage URL
Email yshinmei@med.hokudai.ac.jp

Sponsor
Institute The department of Ophthalmology of Hokkaido University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 06 Month 19 Day
Anticipated trial start date
2014 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 06 Month 19 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016668


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