UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006628 |
|---|---|
| Receipt number | R000007841 |
| Scientific Title | Efficacy of multifocal intraocular lens in cataract surgery |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2019/05/04 09:58:21 |
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Basic information
Public title
Efficacy of multifocal intraocular lens in cataract surgery
Acronym
multifocal intraocular lens in cataract surgery
Scientific Title
Efficacy of multifocal intraocular lens in cataract surgery
Scientific Title:Acronym
multifocal intraocular lens in cataract surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of multifocal intraocular lens
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity
Key secondary outcomes
refraction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
From Dec/2011 untill Aug/2016
fifteen cases of multifocal intraocular lens in cataract surgery
Interventions/Control_2
From Dec/2011 untill Aug/2016
fifteen cases of monofocal intraocular lens in cataract surgery
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
corneal curvature within -1.00D
Key exclusion criteria
High frequency of driving in night
Dislike of clothing glasses and contact lens
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | Murata |
Organization
Shinshu university
Division name
Ophthalmology
Zip code
390-8621
Address
1-1-3 Asahi Matsumoto-shi Nagano JAPAN
TEL
0263-37-2664
ieganka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kyomoto |
Organization
Shinshu University
Division name
Ophthalmology
Zip code
390-8621
Address
1-1-3 Asahi Matsumoto-shi Nagano JAPAN
TEL
0263-37-2664
Homepage URL
ieganka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Shinshu University hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Ophthalmology
Address
1-1-3 Asahi Matsumoto-shi Nagano JAPAN
Tel
0263-35-4600
ieganka@shinshu-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
| 2011 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 28 | Day |
Last modified on
| 2019 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007841
