UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016028 |
|---|---|
| Receipt number | R000018580 |
| Scientific Title | Multifocal Intraocular Lens Inplantation in cataract patients |
| Date of disclosure of the study information | 2014/12/24 |
| Last modified on | 2019/06/26 14:12:05 |
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Basic information
Public title
Multifocal Intraocular Lens Inplantation in cataract patients
Acronym
Multifocal Intraocular Lens
Scientific Title
Multifocal Intraocular Lens Inplantation in cataract patients
Scientific Title:Acronym
Multifocal Intraocular Lens
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of multifocal intraocular lens, inserted in cataract patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative far and near visual acuity, porefractive power
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
multifocal intraocular lens inplantation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cataract patients who have no other ocular disease
patients who show agreement by the written consent
Key exclusion criteria
patients who refuse the operation
patients that the study chief and coworker judge as inappropriate participants
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Yoshizako |
Organization
Shimane University
Division name
Department of Ophthalmology
Zip code
Address
89-1 Enya-cho, Izumo City, Shimane
TEL
0853-23-2111
hyoshiza@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Yoshizako |
Organization
Shimane University
Division name
Department of Ophthalmology
Zip code
Address
89-1 Enya-cho, Izumo City, Shimane
TEL
0853-23-2111
Homepage URL
hyoshiza@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane 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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 24 | 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
| 2014 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018580
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
