UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	driving simulation and kinetic visual acuity in eyes with posterior chamber phakic intraocular lens implantation
Title of the study (Brief title)	driving simulation and kinetic visual acuity in eyes with posterior chamber phakic intraocular lens implantation
Region	Japan

Condition
Condition	refractive error
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The superiority of the art backsight function is reported as well as safety, the effectiveness that is higher than LASIK, but which operation goes wrong and notices a and hello, and, as for the back room type existence crystalline lens intraocular lens, possibility to affect it at the time of driving is thought about. However, because the influence on important driving and kinetic vision to play its part is not done as a means of transportation for a patient after this art until now, I compare it with the normalcy eyes of the same age and examine the influence by this operation quantitatively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Honda driving simulation kinetic vision tester cowa AS-4F
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	Person having a common car license
Key exclusion criteria	The person who does not usually have car licenses
Target sample size	40

Research contact person
Name of lead principal investigator	Kamiya Kazutaka
Organization	Kitasato university school of allied health Sciences
Division name	Sight function therapy studies specialty
Address	Minami-ku, Sagamihara-shi, Kanagawa Kitasato 1-15-1
TEL	042-778-9681
Email	kamiyak-kty@umin.ac.jp

Public contact
Name of contact person	Kamiya Kazutaka
Organization	Kitasato university school of allied health Sciences
Division name	Sight function therapy studies specialty
Address	Minami-ku, Sagamihara-shi, Kanagawa Kitasato 1-15-1
TEL	042-778-9681
Homepage URL
Email	kamiyak-kty@umin.ac.jp

Sponsor
Institute	Kitasato university
Institute
Department

Funding Source
Organization	No
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	北里大学医療衛生学部(神奈川県)

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 05 Month 16 Day
Anticipated trial start date	2018 Year 05 Month 16 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	The name, the date of birth, sex, distant view eyesight level, kinetic vision level, steering wheel operation, attention distribution, plural work, run result data

Management information
Registered date	2018 Year 05 Month 16 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037185