UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032067 |
|---|---|
| Receipt number | R000036582 |
| Scientific Title | The relationship between glaucomatous optic neuropathy and posture-induced intraocular pressure changes |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2021/05/23 16:20:16 |
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Basic information
Public title
The relationship between glaucomatous optic neuropathy and posture-induced intraocular pressure changes
Acronym
Glaucoma and posture-induced intraocular pressure changes
Scientific Title
The relationship between glaucomatous optic neuropathy and posture-induced intraocular pressure changes
Scientific Title:Acronym
Glaucoma and posture-induced intraocular pressure changes
Region
| Japan |
Condition
Condition
glaucoma patients and normal volunteers
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether intraocular pressure changes would be deeply implicated in glaucoma progression
Basic objectives2
Others
Basic objectives -Others
To investigate posture-induced intraocular pressure changes after surgical intervention
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
intraocular pressure in the lateral decubitus position minus that in the sitting position
Key secondary outcomes
The results from visual field and optical coherence tomography
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
glaucoma patients and normal volunteers
Key exclusion criteria
cases with ocular abnormalities except glaucoma and cataract
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sawada |
Organization
Gifu University Graduate School of Medicine
Division name
Ophthalmology
Zip code
501-1194
Address
1-1, Yanagido, Gifu 501-1194, Japan
TEL
058-230-6288
sawadaa-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sawada |
Organization
Gifu University Graduate School of Medicine
Division name
Ophthalmology
Zip code
501-1194
Address
1-1, Yanagido, Gifu 501-1194, Japan
TEL
058-230-6288
Homepage URL
sawadaa-gif@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Graduate School of Medicine
Address
1-1, Yanagido, Gifu 501-1194, Japan
Tel
058-230-6059
rinri@gifu-u.ac.jp
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
| 2020 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 04 | Month | 02 | Day |
Last modified on
| 2021 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036582
