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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006834
Receipt No. R000008088
Scientific Title Evaluation of the quality of life after Laser in situ keratomileusis(LASIK)
Date of disclosure of the study information 2011/12/06
Last modified on 2019/03/11

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Basic information
Public title Evaluation of the quality of life after Laser in situ keratomileusis(LASIK)
Acronym Evaluation of the quality of life after Laser in situ keratomileusis(LASIK)
Scientific Title Evaluation of the quality of life after Laser in situ keratomileusis(LASIK)
Scientific Title:Acronym Evaluation of the quality of life after Laser in situ keratomileusis(LASIK)
Region
Japan

Condition
Condition Patients who operated on LASIK
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the quality of life after Laser in situ keratomileusis(LASIK)
Basic objectives2 Others
Basic objectives -Others Subjective quality of vision and quality of life using SF-36
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual acuity, subjective quality of vision ,quality of life
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent LASIK
Key exclusion criteria A person who did not agree to this study.
A person whose examination was with many mention errors
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaoru Fujii
Organization Keio University
Division name Health center
Zip code
Address 2-15-45 Mita Minato-ku Tokyo
TEL 03-5427-1607
Email kaoru.fujii@adst.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Fujii
Organization Keio University
Division name Health center
Zip code
Address 2-15-45 Mita Minato-ku Tokyo
TEL 03-5427-1607
Homepage URL
Email kaoru.fujii@adst.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio Gijuku Academic Development Funds
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 南青山アイクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 06 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 Completed
Date of protocol fixation
2011 Year 11 Month 26 Day
Date of IRB
2011 Year 11 Month 01 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Visual acuity, subjective quality of vision ,quality of life

Management information
Registered date
2011 Year 12 Month 05 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008088

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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