UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010756 |
|---|---|
| Receipt number | R000012571 |
| Scientific Title | The influence that low-concentrated muscarinic receptor inhibition eye drops give to an eyeball |
| Date of disclosure of the study information | 2013/05/20 |
| Last modified on | 2016/08/17 16:26:47 |
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Basic information
Public title
The influence that low-concentrated muscarinic receptor inhibition eye drops give to an eyeball
Acronym
Influence on eyeball of low-concentrated atropine
Scientific Title
The influence that low-concentrated muscarinic receptor inhibition eye drops give to an eyeball
Scientific Title:Acronym
Influence on eyeball of low-concentrated atropine
Region
| Japan |
Condition
Condition
The volunteer that adjustment powers not to have eye disease except the ametropia are enough
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I investigate the action to an eyeball of the low-concentrated atropine instillation thoroughly.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pupil diameter
Accommodation
Key secondary outcomes
Wavefront aberration
Axial length
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
0.1% atropine instillation
Interventions/Control_2
0.05% atropine instillation
Interventions/Control_3
0.025% atropine instillation
Interventions/Control_4
0.01% atropine instillation
Interventions/Control_5
0.005% atropine instillation
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
accommodation enough
Key exclusion criteria
a whole body disease and eye disease except the ametropia
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kinohsita |
Organization
Kyoto Prefectrural University of Medicine
Division name
ophthalmology
Zip code
Address
465, Kajiicho in Kawaramachi, Kamigyo-ku, Kyoto-City, Japan
TEL
075-251-5578
shigeruk@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Hieda |
Organization
Kyoto Prefectrural University of Medicine
Division name
ophthalmology
Zip code
Address
465, Kajiicho in Kawaramachi, Kamigyo-ku, Kyoto-City, Japan
TEL
075-251-5578
Homepage URL
ohieda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectrural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants for Scientific Research
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
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
| 2013 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The effect duration of the low-concentrated atropine was relatively short
The effect to a pupil is present
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
Main results already published
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 20 | 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
| 2013 | Year | 05 | Month | 18 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012571
