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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020706
Receipt No. 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

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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
Email 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
Email yshinmei@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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