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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015167
Receipt No. 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

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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
Email 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
Email shincova@gmail.com

Sponsor
Institute Nippon Medical School, Tama-Nagayama Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017640

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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