UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Outcomes of Small Incision Lenticule Extraction. A Multicenter Study.
Title of the study (Brief title)	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	Kazutaka Kamiya
Organization	Kitasato University
Division name	School of Allied Health Sciences
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	Kazutaka Kamiya
Organization	Kitasato University
Division name	School of Allied Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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