UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015167 |
|---|---|
| Receipt number | R000017640 |
| Scientific Title | Evaluation for the new developing Toric degree gauge, especially as those postoperative outcome. |
| Date of disclosure of the study information | 2014/10/30 |
| Last modified on | 2019/09/22 08:59:48 |
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Basic information
Public title
Evaluation for the new developing Toric degree gauge, especially as those postoperative outcome.
Acronym
Evaluation for the new toric degree gauge
Scientific Title
Evaluation for the new developing Toric degree gauge, especially as those postoperative outcome.
Scientific Title:Acronym
Evaluation for the new toric degree gauge
Region
| Japan |
Condition
Condition
cataract
astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for the new developing Toric degree gauge, especially as those postoperative outcome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the postoperative visual acuity, refractive error, astigmatism and axis.
Key secondary outcomes
complication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cataract cases using Toric IOL
Key exclusion criteria
Cases not using Toric IOL
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | shinichiro |
| Middle name | |
| Last name | Shinichiro |
Organization
Nippon Medical School, Tama-Nagayama Hospital
Division name
Ophthalmology
Zip code
206-8512
Address
1-7-1, Nagayama, Tama-city
TEL
0423712111
shincova@gmail.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kobayakawa |
Organization
Nippon Medical School
Division name
Ophthalmology
Zip code
206-8512
Address
1-7-1, Nagayama, Tama-city
TEL
0423712111
Homepage URL
shincova@gmail.com
Sponsor or person
Institute
Nippon Medical School, Tama-Nagayama Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School, Tama-Nagayama Hospital
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
Nippon Medical School Tama-Nagayama Hospital
Address
1-7-1, Nagayama, Tama-city
Tel
042-371-2111
s-kobayakawa@nms.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
日本医科大学多摩永山病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.nms.ac.jp/tama-h/section/ophthalmology.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nms.ac.jp/tama-h/section/ophthalmology.html
Number of participants that the trial has enrolled
100
Results
No significant differences with conventional methods
Results date posted
| 2019 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
cataract patients
Participant flow
surgery done
Adverse events
none
Outcome measures
visual acuity, astigmatism
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
compare the results with conventional methods
Management information
Registered date
| 2014 | Year | 09 | Month | 16 | Day |
Last modified on
| 2019 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017640
| 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 |
