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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032612
Receipt No. R000037185
Scientific Title driving simulation and kinetic visual acuity in eyes with posterior chamber phakic intraocular lens implantation
Date of disclosure of the study information 2018/05/16
Last modified on 2019/01/29

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Basic information
Public title driving simulation and kinetic visual acuity in eyes with posterior chamber phakic intraocular lens implantation
Acronym driving simulation and kinetic visual acuity in eyes with posterior chamber phakic intraocular lens implantation
Scientific Title driving simulation and kinetic visual acuity in eyes with posterior chamber phakic intraocular lens implantation
Scientific Title:Acronym 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
1st name
Middle name
Last name Kamiya Kazutaka
Organization Kitasato university school of allied health Sciences
Division name Sight function therapy studies specialty
Zip code
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
1st name
Middle name
Last name Kamiya Kazutaka
Organization Kitasato university school of allied health Sciences
Division name Sight function therapy studies specialty
Zip code
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)

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 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

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 Main results already published
Date of protocol fixation
2018 Year 05 Month 16 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000037185

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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