UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020706 |
|---|---|
| Receipt number | R000023894 |
| Scientific Title | The evaluation of fluid replacement test for the patient with glaucoma and optic neuropathy. |
| Date of disclosure of the study information | 2016/01/23 |
| Last modified on | 2016/01/26 17:53:15 |
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Basic information
Public title
The evaluation of fluid replacement test for the patient with glaucoma and optic neuropathy.
Acronym
The fluid replacement test for glaucoma and optic neuropathy.
Scientific Title
The evaluation of fluid replacement test for the patient with glaucoma and optic neuropathy.
Scientific Title:Acronym
The fluid replacement test for glaucoma and optic neuropathy.
Region
| Japan |
Condition
Condition
1.Glaucoma
2.Optic neuropathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to investigate the roles of intracranial hypotension in visual field defect of glaucoma and optic neuropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure before and after a rapid parenteral fluid replacement.
Optic nerve sheath diameters measured with MRI before and after a rapid parenteral fluid replacement.
Visual fields before and after a rapid parenteral fluid replacement.
Visual acuity before and after a rapid parenteral 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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Rapid parenteral fluid replacement(500ml of lactated Ringer and 500ml of maintenance transfusion/hour) for the patient with glaucoma and optic neuropathy.
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patient with visual field defects.
2. The patient who sufficiently understand visual field test.
3. The patient who can safely undergo MRI.
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 with metal in their body or claustrophobia.
5. The patient that is not appropriate as the subject by the judgement of principal researcher.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shinmei |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5944
yshinmei@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shinmei |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5944
Homepage URL
yshinmei@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine
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
| 2016 | Year | 01 | Month | 23 | 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
| 2016 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | 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
| 2016 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023894
