UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of surgical induced astigmatism according to incision site after phakic intraocular lens implantation
Acronym	Comparison of surgical induced astigmatism according to incision site after phakic intraocular lens implantation
Scientific Title	Comparison of surgical induced astigmatism according to incision site after phakic intraocular lens implantation
Scientific Title:Acronym	Comparison of surgical induced astigmatism according to incision site after phakic intraocular lens implantation
Region	Japan

Condition
Condition	myopia,astigmatism
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of surgical induced astigmatism according to incision site after phakic intraocular lens implantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate induced astigmatism at 1 month after surgery
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	refractive error
Key exclusion criteria	There are ophthalmic diseases other than refractive error.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name kazutaka Middle name Last name kamiya
Organization	kitasato university hospital
Division name	Ophthalmology
Zip code	2520375
Address	1-15-1 kitasato,minami,sagamihara,kanagawa
TEL	042-778-8111
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	1st name wakako Middle name Last name ando
Organization	kitasato university hospital
Division name	Ophthalmology
Zip code	2520375
Address	1-15-1 kitasato,minami,sagamihara,kanagawa
TEL	042-778-8111
Homepage URL
Email	wakako@kitasato-u.ac.jp

Sponsor
Institute	kitasato university hospital
Institute
Department

Funding Source
Organization	kitasato university hospital
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	kitasato university hospital
Address	1-15-1 kitasato,minami,sagamihara,kanagawa
Tel	042-778-8111
Email	rinrib@med.kitasato-u.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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 21 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	100
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	2020 Year 11 Month 01 Day
Date of IRB	2021 Year 01 Month 08 Day
Anticipated trial start date	2021 Year 01 Month 08 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A cohort study of patients who underwent ICL insertion at kitasato university hospital from January 1, 2019 to December 31, 2019.

Management information
Registered date	2021 Year 05 Month 20 Day
Last modified on	2021 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050561