UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032612 |
|---|---|
| Receipt number | 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 09:10:08 |
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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
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
kamiyak-kty@umin.ac.jp
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037185
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
