UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018273 |
|---|---|
| Receipt number | R000019103 |
| Scientific Title | A clinical study of the relation between 24-hour intraocular pressure and activities. |
| Date of disclosure of the study information | 2015/07/11 |
| Last modified on | 2020/07/14 11:25:31 |
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Basic information
Public title
A clinical study of the relation between 24-hour intraocular pressure and activities.
Acronym
The relation between 24h IOP and activities.
Scientific Title
A clinical study of the relation between 24-hour intraocular pressure and activities.
Scientific Title:Acronym
The relation between 24h IOP and activities.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation between 24 hour activities and intra-ocular pressure with wearable activity monitor and with wearable intra-ocular pressure monitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To confirm between activities' changes and intra-ocular pressure's changes.
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects and glaucoma patients.
Key exclusion criteria
Cases of corneal erosion, corneal ulcer, signs of inflammatory eye disease. Cases of post glaucoma filtering surgery.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ishikawa |
| Middle name | |
| Last name | Shinichiro |
Organization
Saga university
Division name
Department of ophthalmology
Zip code
8498501
Address
Nabeshima 5-1, Saga city, Saga prefecture, Japan
TEL
0952-34-2384
c1441@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Kimura |
| Middle name | |
| Last name | Shinya |
Organization
Saga university
Division name
IRB
Zip code
8498501
Address
Nabeshima 5-1, Saga city, Saga prefecture, Japan
TEL
0952-34-2384
Homepage URL
c1441@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga university
Institute
Department
Personal name
Funding Source
Organization
Saga university
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
Saga university hospital
Address
Nabeshima 5-1, Saga city, Saga prefecture, Japan
Tel
0952343357
c1441@cc.saga-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
| 2015 | Year | 07 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Activities' changes are corrected by Fitbit (Fitbit, SanFrancisco USA) and intra-ocular pressure's changes are corrected by Triggerfish(Sensimed, Lausanne Switzerland). Prospective, random sample study.
Management information
Registered date
| 2015 | Year | 07 | Month | 11 | Day |
Last modified on
| 2020 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019103
