UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051891 |
|---|---|
| Receipt number | R000059210 |
| Scientific Title | Exploratory study of contributory factors of presbyopia |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2023/08/11 08:22:16 |
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Basic information
Public title
Exploratory study of contributory factors of presbyopia
Acronym
Contributory factors of presbyopia
Scientific Title
Exploratory study of contributory factors of presbyopia
Scientific Title:Acronym
Contributory factors of presbyopia
Region
| Japan |
Condition
Condition
presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore contributory factors of presbyopia in eye clinic patients
Basic objectives2
Others
Basic objectives -Others
To contibute to diagnosis and treatment of presbyopia by analysis of factors on presbyopia
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
severity of presbyopia
Key secondary outcomes
age, ocular findings
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
| 10 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
best corrected vusual acuity better than 20/30
Key exclusion criteria
within one month after eye surgery
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | masahiko |
| Middle name | |
| Last name | ayaki |
Organization
ootake eye clinic
Division name
eye
Zip code
1580082
Address
Yamato city, Kanagawa, Japan
TEL
09022118355
mayaki@olive.ocn.ne.jp
Public contact
Name of contact person
| 1st name | masahiko |
| Middle name | |
| Last name | ayaki |
Organization
ootake eye clinic
Division name
eye
Zip code
1580082
Address
Yamato city, Kanagawa, Japan
TEL
09022118355
Homepage URL
mayaki@olive.ocn.ne.jp
Sponsor or person
Institute
ootake eye clinic
Institute
Department
Personal name
Funding Source
Organization
self funding
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
kanagawa medical association
Address
yokohama, kanagawa
Tel
045-241-7000
k-arai@kanagawa.med.or.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
| 2023 | Year | 08 | Month | 15 | 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
Suspended
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
severity of presbyopia, ocular findings
Management information
Registered date
| 2023 | Year | 08 | Month | 11 | Day |
Last modified on
| 2023 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
