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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031473
Receipt No. R000035926
Scientific Title Clinical Outcomes of Small Incision Lenticule Extraction. A Multicenter Study.
Date of disclosure of the study information 2018/02/26
Last modified on 2018/02/25

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Basic information
Public title Clinical Outcomes of Small Incision Lenticule Extraction. A Multicenter Study.
Acronym Clinical Outcomes of Small Incision Lenticule Extraction.
Scientific Title Clinical Outcomes of Small Incision Lenticule Extraction. A Multicenter Study.
Scientific Title:Acronym Clinical Outcomes of Small Incision Lenticule Extraction.
Region
Japan

Condition
Condition Myopia and Myopic Astigmatism
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To retrospectively assess the clinical outcomes of SMILE as a multicenter study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, refraction, predictability, stability, adverse events
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Intolerance of eyes glass and contract lens, Myopia and myopic astigmatism
Key exclusion criteria Corneal diseases, Previous history of ocular surgery or ocular trauma
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Email kamiyak-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Homepage URL
Email kamiyak-tky@umin.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 26 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
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preoperatively and 3 months postoperatively, we assessed the safety, efficacy, predictability, and adverse events of surgery.

Management information
Registered date
2018 Year 02 Month 25 Day
Last modified on
2018 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035926

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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